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 |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Bernardo, Nelson L |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Case, Brian C |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Chen, Yuefeng |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Chezar-Azerrad, Chava |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Dheendsa, Aaphtaab |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Forrestal, Brian J |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Hashim, Hayder |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Javed, Hasan |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Khalid, Nauman |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Khan, Jaffar M |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Musallam, Anees |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Rogers, Toby |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Satler, Lowell F |
700 ## - ADDED ENTRY--PERSONAL NAME |
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 |