Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database. (Record no. 5874)

MARC details
000 -LEADER
fixed length control field 04938nam a22007457a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 201229s20202020 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1878-0938
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1016/j.carrev.2020.08.038 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code S1553-8389(20)30507-8 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 33071196
245 ## - TITLE STATEMENT
Title Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database.
251 ## - Source
Source Cardiovascular Revascularization Medicine. 27:57-62, 2021 06.
252 ## - Abbreviated Source
Abbreviated source Cardiovasc Revasc Med. 27:57-62, 2021 06.
252 ## - Abbreviated Source
Former abbreviated source Cardiovasc Revasc Med. 2020 Aug 27
253 ## - Journal Name
Journal name Cardiovascular revascularization medicine : including molecular interventions
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2021
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2021
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2020-12-29
268 ## - Previous citation
-- Cardiovascular Revascularization Medicine. 2020 Aug 27
269 ## - Original dates
Original fiscal year FY2021
501 ## - WITH NOTE
Local holdings Available in print through MWHC library: 2002 - present
520 ## - SUMMARY, ETC.
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.
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract 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.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Atherectomy, Coronary
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Coronary Artery Disease
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Atherectomy, Coronary/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Coronary Artery Disease/dg [Diagnostic Imaging]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Coronary Artery Disease/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Databases, Factual
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Risk Factors
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element United States
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element United States Food and Drug Administration
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Ben-Dor, Itsik
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Local Authors Bernardo, Nelson L
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Local Authors Case, Brian C
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Local Authors Chen, Yuefeng
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Chezar-Azerrad, Chava
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Local Authors Dheendsa, Aaphtaab
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Forrestal, Brian J
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Local Authors Hashim, Hayder
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Local Authors Javed, Hasan
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Local Authors Khalid, Nauman
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Local Authors Khan, Jaffar M
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Local Authors Musallam, Anees
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Local Authors Rogers, Toby
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Satler, Lowell F
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Local Authors Shlofmitz, Evan
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Waksman, Ron
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Wermers, Jason P
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Yerasi, Charan
790 ## - Authors
All authors 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
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1016/j.carrev.2020.08.038">https://dx.doi.org/10.1016/j.carrev.2020.08.038</a>
Public note https://dx.doi.org/10.1016/j.carrev.2020.08.038
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
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