Poll: Suture-Based Vascular Closure Devices
A recently published review1 of reports of complications of suture-based vascular closure devices from the US Food & Drug Administration MAUDE (Manufacturer and User Facility Device Experience) post-marketing surveillance database identified 827 reports of major complications with Perclose ProGlide (Abbott Cardiovascular; Abbott Park, IL) and 175 reports of major complications with Prostar XL (Abbott Cardiovascular; Abbott Park, IL). Actual injury occurred in 404 Perclose ProGlide complications and 94 Prostar XL complications, including 1 death in each group. Complications included failure to deploy, bleeding, hematoma, and device failure, including suture or deployment issues. The authors conclude that appropriate patient selection and operator training are important components of safe use of these devices.
- Case BC, Kumar S, Yerasi C, et al. Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience. Catheter Cardiovasc Interv 2021;Feb 4:[Epub ahead of print].
Keywords: Coronary Angiography, Vascular Closure Devices, Patient Selection, Laboratories, Sutures, Hemorrhage, Hematoma, Equipment Failure, Reference Standards, Pharmaceutical Preparations
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