Real-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. (Record no. 4809)

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
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
          MedStar Authors Catalog MedStar Authors Catalog 12/17/2019   31780421 31780421 12/17/2019 12/17/2019 Journal Article

Powered by Koha