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Liao TJ, Crosby L, Cross K, Chen M, Elespuru R. Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects. Regul Toxicol Pharmacol 2024; 149:105591. [PMID: 38467236 DOI: 10.1016/j.yrtph.2024.105591] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2023] [Revised: 02/09/2024] [Accepted: 02/21/2024] [Indexed: 03/13/2024]
Abstract
Post-market medical device-associated failures and patient problems are reported in Medical Device Reports (MDRs) to the US Food and Drug Administration. Reports are accessible through Manufacturer and User Facility Device Experience (MAUDE), a database including both required and voluntary submissions. We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated "no health consequences"; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred more frequently in females, many of which were related to immune effects. The analyses are subject to uncertainties and potential bias based on data available and data selected for analysis. However, such an overview of post-market MDR data, not previously published, fills a gap in understanding medical device issues and patient-based outcomes related to medical device use. Trends identified may be subjects of additional hypotheses, analysis, and research.
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Affiliation(s)
- Tsung-Jen Liao
- Office of Research, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA
| | - Lynn Crosby
- Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA
| | | | - Minjun Chen
- Office of Research, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA
| | - Rosalie Elespuru
- Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
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2
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Ahrari A, Healy GM, Min A, Alkhalifah F, Oreopoulos G, Teng Tan K, Jaberi A, Rajan DK, Mafeld S. Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database. J Endovasc Ther 2023:15266028231219226. [PMID: 38110358 DOI: 10.1177/15266028231219226] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2023]
Abstract
PURPOSE Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. MATERIALS AND METHODS Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. RESULTS There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). CONCLUSIONS The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. CLINICAL IMPACT Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.
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Affiliation(s)
- Aida Ahrari
- Department of Radiology, University of Toronto, Toronto, ON, Canada
- Joint Department of Medical Imaging, University Health Network and Sinai Health System, Toronto, ON, Canada
| | - Gerard M Healy
- Department of Radiology, St Vincent's University Hospital, Dublin, Ireland
| | - Adam Min
- Department of Radiology, University of Toronto, Toronto, ON, Canada
- Joint Department of Medical Imaging, University Health Network and Sinai Health System, Toronto, ON, Canada
| | - Fahd Alkhalifah
- Department of Radiology, University of Toronto, Toronto, ON, Canada
- Joint Department of Medical Imaging, University Health Network and Sinai Health System, Toronto, ON, Canada
| | - George Oreopoulos
- Joint Department of Medical Imaging, University Health Network and Sinai Health System, Toronto, ON, Canada
- Division of Vascular Surgery, University Health Network, Toronto, ON, Canada
| | - Kong Teng Tan
- Department of Radiology, University of Toronto, Toronto, ON, Canada
- Joint Department of Medical Imaging, University Health Network and Sinai Health System, Toronto, ON, Canada
| | - Arash Jaberi
- Department of Radiology, University of Toronto, Toronto, ON, Canada
- Joint Department of Medical Imaging, University Health Network and Sinai Health System, Toronto, ON, Canada
| | - Dheeraj K Rajan
- Department of Radiology, University of Toronto, Toronto, ON, Canada
- Joint Department of Medical Imaging, University Health Network and Sinai Health System, Toronto, ON, Canada
| | - Sebastian Mafeld
- Department of Radiology, University of Toronto, Toronto, ON, Canada
- Joint Department of Medical Imaging, University Health Network and Sinai Health System, Toronto, ON, Canada
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Sheikh AS, Connolly DL, Abdul F, Varma C, Sharma V. Intravascular lithotripsy for severe coronary calcification: a systematic review. Minerva Cardiol Angiol 2023; 71:643-652. [PMID: 34713678 DOI: 10.23736/s2724-5683.21.05776-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
INTRODUCTION Coronary artery calcification remains a challenge in percutaneous coronary interventions, due to the higher risk of suboptimal result with subsequent poor clinical outcomes. Intravascular lithotripsy is a novel way of treating severe coronary calcification as it has the ability to modify calcium both circumferentially as well as transmurally, facilitating stent expansion and apposition. We conducted a systematic overview of the published literature on intravascular lithotripsy (IVL) assessing the efficacy and feasibility of IVL in treating severe coronary calcification. EVIDENCE ACQUISITION Of the retrieved publications, 62 met our inclusion criteria and were included. A total of 1389 patients (1414 lesions) with significant coronary calcification or under-expanded stents underwent IVL. EVIDENCE SYNTHESIS The mean age was 72.03 years (74.7% male). There was a significant improvement in acute and sustained vessel patency, with mean minimal lumen diameter of 2.78±0.46 mm, resulting in acute gain of 1.72±0.51 mm. The acute procedural success rate was 78.2 to 100% with in-hospital complication rate of 5.6 to 7.0%. The majority of the studies reported 30-day MACE, which was between 2.2 to 7.8%. CONCLUSIONS The recent studies have highlighted that the use of IVL with adjuvant intracoronary imaging has revolutionized the way of treating heavily calcified, non-dilatable coronary lesions and is likely to succeed the conventional ways of treating these complex lesions. We need further studies to gauge the long-term efficacy and safety of IVL against techniques currently available for calcium modification including conventional balloons, cutting or scoring balloons, rotational atherectomy and laser atherectomy.
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Affiliation(s)
- Azeem S Sheikh
- Department of Cardiology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK -
| | - Derek L Connolly
- Department of Cardiology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
| | - Fairoz Abdul
- Department of Cardiology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
| | - Chetan Varma
- Department of Cardiology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
| | - Vinoda Sharma
- Department of Cardiology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
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Khalid N, Ahmad SA. Editorial: Adverse events from intra-aortic balloon counterpulsation therapy: Insights from the MAUDE database. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2023; 56:41-42. [PMID: 37544803 DOI: 10.1016/j.carrev.2023.07.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2023] [Accepted: 07/18/2023] [Indexed: 08/08/2023]
Affiliation(s)
- Nauman Khalid
- Section of Interventional Cardiology, St. Francis Medical Center, Monroe, LA, USA.
| | - Sarah Aftab Ahmad
- Section of Cardiothoracic Surgery, St. Francis Medical Center, Monroe, LA, USA
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Rola P, Włodarczak S, Barycki M, Furtan Ł, Jastrzębski A, Kędzierska M, Doroszko A, Lesiak M, Włodarczak A. Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR). J Clin Med 2023; 12:5842. [PMID: 37762782 PMCID: PMC10532293 DOI: 10.3390/jcm12185842] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/11/2023] [Revised: 08/24/2023] [Accepted: 09/06/2023] [Indexed: 09/29/2023] Open
Abstract
BACKGROUND Coronary calcifications represent a challenging subset for the interventional cardiologist performing percutaneous coronary intervention (PCI) and are well-established risk factors for adverse outcomes. Adequate plaque modification prior to stent implantation is critical to achieve an optimal outcome following PCI. Recently, a novel orbital atherectomy device has been introduced into clinical practice to modify calcified plaques. We evaluated the mid-term safety and efficacy of OA in a high-risk "all-comers" population. METHODS We evaluated 96 consecutive patients with severely calcified coronary lesions who underwent PCI facilitated by the orbital atherectomy device. RESULTS In-hospital MACCE was 5.2% without target lesion revascularization. At 6-month follow-up, the MACCE rate was 10.4% with a concomitant TLR rate of 1%. CONCLUSIONS Our mid-term data showed good safety and efficacy of orbital atherectomy as a plaque-modifying tool in an all-comers cohort with severely calcified coronary lesions.
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Affiliation(s)
- Piotr Rola
- Faculty of Health Sciences and Physical Culture, Witelon Collegium State University, 59-220 Legnica, Poland;
- Department of Cardiology, Provincial Specialized Hospital, 59-220 Legnica, Poland; (M.B.); (Ł.F.)
| | - Szymon Włodarczak
- Department of Cardiology, The Copper Health Centre (MCZ), 59-300 Lubin, Poland; (S.W.); (A.J.)
| | - Mateusz Barycki
- Department of Cardiology, Provincial Specialized Hospital, 59-220 Legnica, Poland; (M.B.); (Ł.F.)
| | - Łukasz Furtan
- Department of Cardiology, Provincial Specialized Hospital, 59-220 Legnica, Poland; (M.B.); (Ł.F.)
| | - Artur Jastrzębski
- Department of Cardiology, The Copper Health Centre (MCZ), 59-300 Lubin, Poland; (S.W.); (A.J.)
| | | | - Adrian Doroszko
- Department of Cardiology, Center for Heart Diseases, 4th Military Hospital, Faculty of Medicine, Wroclaw University of Science and Technology, 50-981 Wroclaw, Poland;
| | - Maciej Lesiak
- 1st Department of Cardiology, University of Medical Sciences, 61-848 Poznan, Poland;
| | - Adrian Włodarczak
- Faculty of Health Sciences and Physical Culture, Witelon Collegium State University, 59-220 Legnica, Poland;
- Department of Cardiology, The Copper Health Centre (MCZ), 59-300 Lubin, Poland; (S.W.); (A.J.)
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Alhusain R, Patel D, Osman H, Subahi A, Ahmed AK, Shaikheldin A, Hussein S, Abdelrahim A, Dandu C, Chalek A, Patel N, Elhussein M, Hamza M, Alamzaib SM, Sattar Y, Alraies MC. Coronary Intra-orbital Atherectomy Complications and Procedural Failure: Insight From the Manufacturer and User Facility Device Experience (MAUDE) Database. Cureus 2023; 15:e40817. [PMID: 37485105 PMCID: PMC10362969 DOI: 10.7759/cureus.40817] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/22/2023] [Indexed: 07/25/2023] Open
Abstract
BACKGROUND The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St. Paul, MN) is the first and only orbital atherectomy system approved by the US FDA for the treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal. METHODS The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports on the Diamondback 360® Coronary from January 2019 to January 2022. RESULTS A total of 566 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 547 reports. The most common mode of failure was break or separation of a device part (40.4%, n = 221) mainly due to breaking in the tip of the ViperWire (66.1%), driveshaft (22.7%), or crown (12.2%). The most common vessel associated with events was the left anterior descending artery (31.4%), followed by the right coronary artery (26.9%), left circumflex (21.6%), and left main coronary artery (6.4%). The most common clinical adverse outcome was perforation (33.0%, n = 181) with 23.7% resulting in cardiac tamponade. Most perforation cases were treated by covered stent (44.2%), surgery (30.5%), stent (98%), and balloon angioplasty (9%). There were 89 (16.3%) events of death with 67% due to perforation (p < 0.001). CONCLUSION Our study provided a glimpse of real-world adverse outcomes and common modes of failure due to orbital atherectomy. The most common mode of failure was the break or separation of a device part and the most common complication was perforation according to the MAUDE database. It will help physicians to anticipate complications and escalate care appropriately.
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Affiliation(s)
| | - Dhruvil Patel
- Internal Medicine, Wayne State University School of Medicine, Detroit, USA
| | - Heba Osman
- Internal Medicine/Pediatrics, Wayne State University Detroit Medical Center, Detroit, USA
| | - Ahmed Subahi
- Internal Medicine, Beaumont Hospital, Detroit, USA
| | | | | | - Sami Hussein
- Internal Medicine, Ascension Saint Joseph Hospital, Chicago, USA
| | | | - Chaitu Dandu
- Vascular Surgery, Wayne State University School of Medicine, Detroit, USA
| | - Adam Chalek
- Internal Medicine, Wayne State University School of Medicine, Detroit, USA
| | - Neel Patel
- Internal Medicine, New York Medical College/Landmark Medical Center, Woonsocket, USA
| | | | | | - Sardar Muhammad Alamzaib
- Cardiovascular Medicine, Marshall University Joan C. Edwards School of Medicine, Huntington, USA
| | - Yasar Sattar
- Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, USA
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7
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Akase H, Okamura T, Fujimura T, Miyazaki Y, Matsuyama T, Yano M. Mechanism of a Stuck Crown of the Orbital Atherectomy System and Successful Retrieval Procedure. JACC Cardiovasc Interv 2022; 15:e89-e90. [PMID: 35151610 DOI: 10.1016/j.jcin.2022.01.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/07/2021] [Accepted: 01/04/2022] [Indexed: 11/28/2022]
Affiliation(s)
- Hideaki Akase
- Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan
| | - Takayuki Okamura
- Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan.
| | - Tatsuhiro Fujimura
- Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan
| | - Yosuke Miyazaki
- Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan
| | - Tetsuya Matsuyama
- Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan
| | - Masafumi Yano
- Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan
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8
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Khalid N, Pandey Y, Khalid U, Kamran H, Wermers JP, Chhabra L, Alam M, Jneid H, Kayani WT. Modes of failure with fractional flow reserve guidewires: Insights from the manufacturer and user facility device experience database. World J Cardiol 2021; 13:223-229. [PMID: 34367506 PMCID: PMC8326154 DOI: 10.4330/wjc.v13.i7.223] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/17/2021] [Revised: 02/26/2021] [Accepted: 07/05/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Fractional flow reserve (FFR) measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques. Robust real-world data on complications and modes of failure of FFR guidewires are limited.
AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database for commonly used FFR guidewires.
METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires [PressureWireTM X (Abbott), CometTM (Boston Scientific), and VerrataTM (Philips)] by searching for the following events: “Injury”, “malfunction”, “death”, and “other”. This yielded 544 reports. After excluding incomplete reports, 486 reports were analyzed.
RESULTS Guidewire tip fracture was the most commonly reported mode of failure, in 174 (35.8%) cases followed by guidewire kinking (n = 152, 31.3%), communication failure (n = 141, 29.0%), and shaft fracture (n = 67, 13.8%). In total, 133 (27.4%) device failures resulted in patient adverse events. The most common adverse event was retained guidewire tip, in 71 (53.4%) cases, followed by freshly deployed stent dislodgment (n = 26, 19.6%) and coronary artery dissection (n = 23, 17.3%). Seven deaths were reported.
CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events. The MAUDE database serves as an important platform for improved collaboration among clinicians, device manufacturers, and regulators to improve device performance and optimize patient outcomes. Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.
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Affiliation(s)
- Nauman Khalid
- Department of Interventional Cardiology, St. Francis Medical Center, Monroe, LA 71201, United States
| | - Yagya Pandey
- Department of Internal Medicine, Baylor College of Medicine, Houston, TX 77030, United States
| | - Umair Khalid
- Department of Interventional Cardiology, Michael E. DeBakey VA Medical Center, Houston, TX 77030, United States
| | - Hassan Kamran
- Department of Interventional Cardiology, Baylor College of Medicine, Houston, TX 77030, United States
| | - Jason P Wermers
- Health Sciences, University of Maryland Graduate School, Baltimore, MD 21201, United States
| | - Lovely Chhabra
- Department of Cardiology, Westchester Medical Center Network Advanced Physician Services, New York, NY 12601, United States
| | - Mahboob Alam
- Department of Interventional Cardiology, Baylor College of Medicine, Houston, TX 77030, United States
| | - Hani Jneid
- Department of Interventional Cardiology, Michael E. DeBakey VA Medical Center, Houston, TX 77030, United States
| | - Waleed Tallat Kayani
- Department of Interventional Cardiology, Baylor College of Medicine, Houston, TX 77030, United States
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Shinoda A, Dan K, Okada H, Fujii M, Tsuzura D, Ichihashi K, Teramura M, Maeda T, Tanaka N, Teramoto T. Fractured Driveshaft Tip and Guidewire of Orbital Atherectomy System Retrieved With Micro Basket Catheter. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2021; 32:77-78. [PMID: 33750658 DOI: 10.1016/j.carrev.2021.03.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/07/2021] [Revised: 02/19/2021] [Accepted: 03/01/2021] [Indexed: 11/20/2022]
Affiliation(s)
- Akira Shinoda
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
| | - Kazuhiro Dan
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan.
| | - Hisashi Okada
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
| | - Masato Fujii
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
| | - Daichi Tsuzura
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
| | - Kei Ichihashi
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
| | - Masanori Teramura
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
| | - Takuya Maeda
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
| | - Nobukiyo Tanaka
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
| | - Tomohiko Teramoto
- Department of Cardiovascular medicine, Ichinomiya Nishi Hospital, Japan
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Case BC, Kumar S, Yerasi C, Forrestal BJ, Musallam A, Chezar-Azerrad C, Khalid N, Shlofmitz E, Chen Y, Khan JM, Satler LF, Ben-Dor I, Hashim H, Bernardo NL, Rogers T, Waksman R. Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience. Catheter Cardiovasc Interv 2021; 98:572-577. [PMID: 33539651 DOI: 10.1002/ccd.29501] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2020] [Accepted: 01/15/2021] [Indexed: 12/17/2022]
Abstract
OBJECTIVES We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). BACKGROUND Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. METHODS Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. RESULTS Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. CONCLUSIONS Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.
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Affiliation(s)
- Brian C Case
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Sant Kumar
- Department of Cardiology, Georgetown University School of Medicine, Washington, District of Columbia
| | - Charan Yerasi
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Brian J Forrestal
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Anees Musallam
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Chava Chezar-Azerrad
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Nauman Khalid
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Evan Shlofmitz
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Yuefeng Chen
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Jaffar M Khan
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.,Cardiovascular Branch, Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland
| | - Lowell F Satler
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Itsik Ben-Dor
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Hayder Hashim
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Nelson L Bernardo
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
| | - Toby Rogers
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.,Cardiovascular Branch, Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland
| | - Ron Waksman
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
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11
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Case BC, Yerasi C, Forrestal BJ, Kumar S, Musallam A, Chezar-Azerrad C, Khalid N, Shlofmitz E, Khan JM, Satler LF, Ben-Dor I, Rogers T, Waksman R. Real-World Experience of the MANTA Closure Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2021; 27:63-66. [PMID: 33402323 DOI: 10.1016/j.carrev.2020.11.023] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/18/2020] [Accepted: 11/18/2020] [Indexed: 12/20/2022]
Abstract
BACKGROUND/PURPOSE The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access-site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania). METHODS/MATERIALS Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports. RESULTS Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1). CONCLUSIONS Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD.
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Affiliation(s)
- Brian C Case
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Charan Yerasi
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Brian J Forrestal
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Sant Kumar
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Anees Musallam
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Chava Chezar-Azerrad
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Nauman Khalid
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Evan Shlofmitz
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Jaffar M Khan
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America
| | - Lowell F Satler
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Itsik Ben-Dor
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Toby Rogers
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America
| | - Ron Waksman
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.
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Khalid N, Javed H, Shlofmitz E, Chen Y, Dheendsa A, Musallam A, Khan JM, Wermers JP, Case BC, Forrestal BJ, Chezar-Azerrad C, Yerasi C, Rogers T, Hashim H, Ben-Dor I, Bernardo NL, Satler L, Waksman R. Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2020; 27:57-62. [PMID: 33071196 DOI: 10.1016/j.carrev.2020.08.038] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2020] [Revised: 08/04/2020] [Accepted: 08/24/2020] [Indexed: 11/18/2022]
Abstract
BACKGROUND/PURPOSE Coronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. METHODS/MATERIALS We queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis. RESULTS Percentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery. CONCLUSION An analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality.
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Affiliation(s)
- Nauman Khalid
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Hasan Javed
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Evan Shlofmitz
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Yuefeng Chen
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Aaphtaab Dheendsa
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Anees Musallam
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Jaffar M Khan
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Jason P Wermers
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Brian C Case
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Brian J Forrestal
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Chava Chezar-Azerrad
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Charan Yerasi
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Toby Rogers
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America
| | - Hayder Hashim
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Itsik Ben-Dor
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Nelson L Bernardo
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Lowell Satler
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America
| | - Ron Waksman
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.
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Sorini Dini C, Nardi G, Ristalli F, Mattesini A, Hamiti B, Di Mario C. Contemporary Approach to Heavily Calcified Coronary Lesions. Interv Cardiol 2019; 14:154-163. [PMID: 31867062 PMCID: PMC6918474 DOI: 10.15420/icr.2019.19.r1] [Citation(s) in RCA: 44] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2019] [Accepted: 09/30/2019] [Indexed: 12/17/2022] Open
Abstract
Percutaneous treatment of heavily calcified coronary lesions still represents a challenge for interventional cardiology, with higher risk of immediate complications, late failure due to stent underexpansion and malapposition, and consequently poor clinical outcome. Good characterisation of calcium distribution with multimodal imaging is important to improve the successful treatment of these lesions. The use of traditional or new dedicated devices for the treatment of calcified lesions allows better lesion preparation; therefore, it is important that we know the different mechanisms and technical features of these devices.
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Affiliation(s)
- Carlotta Sorini Dini
- Structural Interventional Cardiology, Careggi University HospitalFlorence, Italy
- Cardiology Division, Spedali RiunitiLivorno, Italy
| | - Giulia Nardi
- Structural Interventional Cardiology, Careggi University HospitalFlorence, Italy
| | - Francesca Ristalli
- Structural Interventional Cardiology, Careggi University HospitalFlorence, Italy
| | - Alessio Mattesini
- Structural Interventional Cardiology, Careggi University HospitalFlorence, Italy
| | - Brunilda Hamiti
- Structural Interventional Cardiology, Careggi University HospitalFlorence, Italy
| | - Carlo Di Mario
- Structural Interventional Cardiology, Careggi University HospitalFlorence, Italy
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