Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience. (Record no. 11369)

MARC details
000 -LEADER
fixed length control field 10477nam a22007097a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 210218s20212021 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1522-1946
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1002/ccd.29501 [doi]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 33539651
245 ## - TITLE STATEMENT
Title Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.
251 ## - Source
Source Catheterization & Cardiovascular Interventions. 98(3):572-577, 2021 09.
252 ## - Abbreviated Source
Abbreviated source Catheter Cardiovasc Interv. 98(3):572-577, 2021 09.
252 ## - Abbreviated Source
Former abbreviated source Catheter Cardiovasc Interv. 2021 Feb 04
253 ## - Journal Name
Journal name Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2021
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2022
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 2021-02-18
268 ## - Previous citation
-- Catheterization & Cardiovascular Interventions. 2021 Feb 04
269 ## - Original dates
Original fiscal year FY2021
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
520 ## - SUMMARY, ETC.
Abstract BACKGROUND: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited.
520 ## - SUMMARY, ETC.
Abstract CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices. Copyright (c) 2021 Wiley Periodicals LLC.
520 ## - SUMMARY, ETC.
Abstract METHODS: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports.
520 ## - SUMMARY, ETC.
Abstract OBJECTIVES: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott).
520 ## - SUMMARY, ETC.
Abstract RESULTS: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vascular Closure Devices
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Femoral Artery/su [Surgery]
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 Sutures
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 Christopher
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 John
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Hashim, Hayder
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 Teja Reddy
790 ## - Authors
All authors Ben-Dor I, Bernardo NL, Case BC, Chen Y, Chezar-Azerrad C, Forrestal BJ, Hashim H, Khalid N, Khan JM, Kumar S, Musallam A, Rogers T, Satler LF, Shlofmitz E, Waksman R, Yerasi C
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1002/ccd.29501">https://dx.doi.org/10.1002/ccd.29501</a>
Public note https://dx.doi.org/10.1002/ccd.29501
858 ## - ORCID
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-- Khan, Jaffar M
-- Satler, Lowell F
-- Shlofmitz, Evan
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858 ## - ORCID
ORCID text Khalid, Nauman
-- Khan, Jaffar M
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858 ## - ORCID
ORCID text Khalid, Nauman
-- Khan, Jaffar M
-- Satler, Lowell F
-- Shlofmitz, Evan
-- Waksman, Ron
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858 ## - ORCID
ORCID text Khalid, Nauman
-- Khan, Jaffar M
-- Satler, Lowell F
-- Shlofmitz, Evan
-- Waksman, Ron
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858 ## - ORCID
ORCID text Khalid, Nauman
-- Khan, Jaffar M
-- Satler, Lowell F
-- Shlofmitz, Evan
-- Waksman, Ron
Orcid <a href="https://orcid.org/0000-0003-4159-555X">https://orcid.org/0000-0003-4159-555X</a>
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942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
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