MedStar Authors catalog › Details for: Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.
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Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

by Case, Brian Christopher; Yerasi, Charan Teja Reddy; Forrestal, Brian John; Musallam, Anees; Chezar-Azerrad, Chava; Khalid, Nauman; Shlofmitz, Evan; Chen, Yuefeng; Khan, Jaffar M; Satler, Lowell F; Ben-Dor, Itsik; Hashim, Hayder; Bernardo, Nelson L; Rogers, Toby; Waksman, Ron.
Citation: Catheterization & Cardiovascular Interventions. 2021 Feb 04.Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.Published: ; 2021ISSN: 1522-1946.Full author list: Case BC; Kumar S; Yerasi C; Forrestal BJ; Musallam A; Chezar-Azerrad C; Khalid N; Shlofmitz E; Chen Y; Khan JM; Satler LF; Ben-Dor I; Hashim H; Bernardo NL; Rogers T; Waksman R.UI/PMID: 33539651.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1002/ccd.29501 (Click here) ORCID: Khalid, Nauman https://orcid.org/0000-0003-4159-555XShlofmitz, Evan https://orcid.org/0000-0002-0907-5258Khan, Jaffar M https://orcid.org/0000-0001-6099-0753Satler, Lowell F https://orcid.org/0000-0001-6446-2683Waksman, Ron https://orcid.org/0000-0002-4063-9226 (Click here) | (Click here) | (Click here) | (Click here) | (Click here) Abbreviated citation: Catheter Cardiovasc Interv. 2021 Feb 04.Local Holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006.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).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.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.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.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.

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