04938nam a22007457a 4500
201229s20202020 xxu||||| |||| 00| 0 eng d
1878-0938
10.1016/j.carrev.2020.08.038 [doi]
S1553-8389(20)30507-8 [pii]
Ovid MEDLINE(R)
33071196
Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database.
Cardiovascular Revascularization Medicine. 27:57-62, 2021 06.
Cardiovasc Revasc Med. 27:57-62, 2021 06.
Cardiovasc Revasc Med. 2020 Aug 27
Cardiovascular revascularization medicine : including molecular interventions
2021
FY2021
aheadofprint
ppublish
2020-12-29
Cardiovascular Revascularization Medicine. 2020 Aug 27
FY2021
Available in print through MWHC library: 2002 - present
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.
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.
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.
SUMMARY: We interrogated the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to summarize the most commonly reported adverse events and device-related issues associated with the rotational atherectomy systems (Rotablator and the newer iteration, Rotapro). The MAUDE database serves as an important tool for improved collaboration between clinicians, device manufacturers, and regulatory bodies to optimize device safety and patient outcomes. Copyright (c) 2020. Published by Elsevier Inc.
English
*Atherectomy, Coronary
*Coronary Artery Disease
Atherectomy, Coronary/ae [Adverse Effects]
Coronary Artery Disease/dg [Diagnostic Imaging]
Coronary Artery Disease/su [Surgery]
Databases, Factual
Humans
Risk Factors
Treatment Outcome
United States
United States Food and Drug Administration
MedStar Heart & Vascular Institute
Journal Article
Ben-Dor, Itsik
Bernardo, Nelson L
Case, Brian C
Chen, Yuefeng
Chezar-Azerrad, Chava
Dheendsa, Aaphtaab
Forrestal, Brian J
Hashim, Hayder
Javed, Hasan
Khalid, Nauman
Khan, Jaffar M
Musallam, Anees
Rogers, Toby
Satler, Lowell F
Shlofmitz, Evan
Waksman, Ron
Wermers, Jason P
Yerasi, Charan
Ben-Dor I, Bernardo NL, Case BC, Chen Y, Chezar-Azerrad C, Dheendsa A, Forrestal BJ, Hashim H, Javed H, Khalid N, Khan JM, Musallam A, Rogers T, Satler L, Shlofmitz E, Waksman R, Wermers JP, Yerasi C
https://dx.doi.org/10.1016/j.carrev.2020.08.038
https://dx.doi.org/10.1016/j.carrev.2020.08.038
ART
Article
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Article
authcat
authcat
2020-12-29
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33071196
33071196
2020-12-29
2020-12-29
ART
5874
5874