MARC details
000 -LEADER |
fixed length control field |
04533nam a22008057a 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
191219s20202020 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.2019.11.014 [doi] |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
S1553-8389(19)30760-2 [pii] |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
Ovid MEDLINE(R) |
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
PMID |
31780421 |
245 ## - TITLE STATEMENT |
Title |
Real-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. |
251 ## - Source |
Source |
Cardiovascular Revascularization Medicine. 21(2):235-238, 2020 02. |
252 ## - Abbreviated Source |
Abbreviated source |
Cardiovasc Revasc Med. 21(2):235-238, 2020 02. |
252 ## - Abbreviated Source |
Former abbreviated source |
Cardiovasc Revasc Med. 2019 Nov 22 |
253 ## - Journal Name |
Journal name |
Cardiovascular revascularization medicine : including molecular interventions |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Year |
2020 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Manufacturer |
FY2020 |
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 |
2019-12-17 |
268 ## - Previous citation |
-- |
Cardiovascular Revascularization Medicine. 2019 Nov 22 |
501 ## - WITH NOTE |
Local holdings |
Available in print through MWHC library: 2002 - present |
520 ## - SUMMARY, ETC. |
Abstract |
BACKGROUND/PURPOSE: The Sentinel Cerebral Protection System (Boston Scientific, Marlborough, Massachusetts) is indicated for use as a cerebral protection device to capture and remove embolic material during transcatheter aortic valve procedures and was approved by the US Food and Drug Administration (FDA) in 2017. Robust data on the most commonly reported complications and modes of failure associated with the Sentinel device are limited. |
520 ## - SUMMARY, ETC. |
Abstract |
CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, the Sentinel Cerebral Protection System may be associated with complications, including death, stroke, vascular injury, and difficulties with the device itself. The MAUDE database serves as an important tool for both physicians and manufacturers to optimize performance and clinical outcomes. Copyright (c) 2019. Published by Elsevier Inc. |
520 ## - SUMMARY, ETC. |
Abstract |
METHODS/MATERIALS: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from 2017 through 2019, yielding 43 reports. |
520 ## - SUMMARY, ETC. |
Abstract |
RESULTS: Of the 43 reports of major complications involving Sentinel devices, 23 involved either death (3) or injury (20) related to the device. The 3 deaths were due to stroke, while 18 of the 20 injuries were reported as stroke. The other 20 reports were related to device modes of failure. Modes of failure were due to damaged device (5), difficulty retrieving/resheathing the device (5); package contamination (4), difficulty deploying the device (3), and, finally, complications with preparation (3). |
546 ## - LANGUAGE NOTE |
Language note |
English |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Device Approval |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Embolic Protection Devices |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Intracranial Embolism/pc [Prevention & Control] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Product Surveillance, Postmarketing |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Stroke/pc [Prevention & Control] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Transcatheter Aortic Valve Replacement/is [Instrumentation] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*United States Food and Drug Administration |
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 |
Intracranial Embolism/dg [Diagnostic Imaging] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Intracranial Embolism/et [Etiology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Intracranial Embolism/mo [Mortality] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Patient Safety |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Prosthesis Design |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Risk Assessment |
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 |
Stroke/dg [Diagnostic Imaging] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Stroke/et [Etiology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Stroke/mo [Mortality] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/mo [Mortality] |
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 |
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 |
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 |
Forrestal, Brian J |
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 |
Yerasi, Charan |
790 ## - Authors |
All authors |
Ben-Dor I, Case BC, Chen Y, Chezar-Azerrad C, Forrestal BJ, Khalid N, Khan JM, Musallam A, Rogers T, Satler LF, Shlofmitz E, Waksman R, Yerasi C |
856 ## - ELECTRONIC LOCATION AND ACCESS |
DOI |
<a href="https://dx.doi.org/10.1016/j.carrev.2019.11.014">https://dx.doi.org/10.1016/j.carrev.2019.11.014</a> |
Public note |
https://dx.doi.org/10.1016/j.carrev.2019.11.014 |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Journal Article |
Item type description |
Article |