Complications and Failure Modes of the Perclose Vascular Closure Device: Insights From MAUDE Database
Journal of the Society for Cardiovascular Angiography & Interventions
The Perclose vascular closure device (VCD) (Abbott Vascular, Redwood City CA) was the first suture mediated closure system approved by the FDA in 1997. Real-world data on the most common mode of failures and complications associated with the use of Perclose
The MAUDE “Manufacturer and User Facility Device Experience” database was quired for reports of Perclose VCD from July 2015 through June 2021.
Of the 108 reports of major complications, 97 reports involved the malfunctioning of the device. The most common modes of failure were detachment or break of the device (36%; n=39), failed deployment (35%; n-38) and Entrapment (19%; n=20). The most common adverse outcome was device embedment within the tissues (30%; n=32). Other less frequent clinical consequence were vessel occlusion, vessel dissection, and bleeding. No deaths were reported.
Despite a high success rate, the Perclose VCD was shown to be associated with complications including device embedment, vascular injury, and bleeding which thought to be likely driven by patient vascular disease severity.
Alhusain R, Awadelkarim A, Bishop P, Chalek A, Dandu C, Zghouzi M, et al. [Elmakshbr N, Gardi DO]. Complications and failure modes of the Perclose vascular closure device: insights from MAUDE database. J Soc Cardiov Angiogr Interv. 2022 May-Jun;1(3 Suppl):100255. doi:10.1016/j.jscai.2022.100255.