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Real‐world experience of suture‐based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience
Author(s) -
Case Brian C.,
Kumar Sant,
Yerasi Charan,
Forrestal Brian J.,
Musallam Anees,
ChezarAzerrad Chava,
Khalid Nauman,
Shlofmitz Evan,
Chen Yuefeng,
Khan Jaffar M.,
Satler Lowell F.,
BenDor Itsik,
Hashim Hayder,
Bernardo Nelson L.,
Rogers Toby,
Waksman Ron
Publication year - 2021
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.29501
Subject(s) - medicine , fibrous joint , vascular closure device , surgery , closure (psychology) , medical emergency , femoral artery , market economy , economics
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). 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. 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. 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. 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.