Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.
Brian C CaseSant KumarCharan YerasiBrian J ForrestalAnees MusallamChava Chezar-AzerradNauman KhalidEvan ShlofmitzYuefeng ChenJaffar M KhanLowell F SatlerItsik Ben-DorHayder HashimNelson L BernardoToby RogersRon WaksmanPublished in: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2021)
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.