000			04533nam a22008057a 4500
008			191219s20202020 xxu||||| |||| 00| 0 eng d
022			_a1878-0938
024			_a10.1016/j.carrev.2019.11.014 [doi]
024			_aS1553-8389(19)30760-2 [pii]
040			_aOvid MEDLINE(R)
099			_a31780421
245			_aReal-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.
251			_aCardiovascular Revascularization Medicine. 21(2):235-238, 2020 02.
252			_aCardiovasc Revasc Med. 21(2):235-238, 2020 02.
252			_zCardiovasc Revasc Med. 2019 Nov 22
253			_aCardiovascular revascularization medicine : including molecular interventions
260			_c2020
260			_fFY2020
265			_saheadofprint
265			_sppublish
266			_d2019-12-17
268			_aCardiovascular Revascularization Medicine. 2019 Nov 22
501			_aAvailable in print through MWHC library: 2002 - present
520			_aBACKGROUND/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			_aCONCLUSIONS: 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			_aMETHODS/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			_aRESULTS: 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			_aEnglish
650			_a*Device Approval
650			_a*Embolic Protection Devices
650			_a*Intracranial Embolism/pc [Prevention & Control]
650			_a*Product Surveillance, Postmarketing
650			_a*Stroke/pc [Prevention & Control]
650			_a*Transcatheter Aortic Valve Replacement/is [Instrumentation]
650			_a*United States Food and Drug Administration
650			_aDatabases, Factual
650			_aHumans
650			_aIntracranial Embolism/dg [Diagnostic Imaging]
650			_aIntracranial Embolism/et [Etiology]
650			_aIntracranial Embolism/mo [Mortality]
650			_aPatient Safety
650			_aProsthesis Design
650			_aRisk Assessment
650			_aRisk Factors
650			_aStroke/dg [Diagnostic Imaging]
650			_aStroke/et [Etiology]
650			_aStroke/mo [Mortality]
650			_aTranscatheter Aortic Valve Replacement/ae [Adverse Effects]
650			_aTranscatheter Aortic Valve Replacement/mo [Mortality]
650			_aTreatment Outcome
650			_aUnited States
651			_aMedStar Heart & Vascular Institute
657			_aJournal Article
700			_aBen-Dor, Itsik
700			_aCase, Brian C
700			_aChen, Yuefeng
700			_aChezar-Azerrad, Chava
700			_aForrestal, Brian J
700			_aKhalid, Nauman
700			_aKhan, Jaffar M
700			_aMusallam, Anees
700			_aRogers, Toby
700			_aSatler, Lowell F
700			_aShlofmitz, Evan
700			_aWaksman, Ron
700			_aYerasi, Charan
790			_aBen-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			_uhttps://dx.doi.org/10.1016/j.carrev.2019.11.014 _zhttps://dx.doi.org/10.1016/j.carrev.2019.11.014
942			_cART _dArticle
999			_c4809 _d4809