Complications of the MANTA Closure Device: Insights From MAUDE Database

BackgroundThe collagen-based MANTA device (Teleflex, PA, USA) is used for closure of large-bore vascular access. There is a paucity of data on complications associated with its use in a real-life setting.MethodsWe queried the “Manufacturer and User Facility Device Experience” MAUDE database between February 2019 and December 2020 for reports on MANTA device.ResultsWe identified 250 reports in the MAUDE database from February 2019 through December 2020. The most common failure complication of MANTA is persistent bleeding (48.8%) and vessel occlusion or stenosis (29.6%). Most complications were managed successfully with an endovascular approach (48.4%), but a high number of patients required surgical intervention (40.4%). The most commonly reported failure mechanism was the failure of deployment (22%) followed by subcutaneous deployment (7.6%), intraluminal deployment (4.8%) amd detachment of collagen (2.8%). Access site infection was rare (1.2%). The 18 Fr. MANTA was associated with a lower risk of failure of deployment compared with the 14 Fr. device but was associated with a higher risk of vessel occlusion or stenosis (32.4% vs. 16.3%, p = 0.04) and thrombosis (11.6% vs 0%, p = 0.03).ConclusionsThe most common complication of the MANTA device reported to the MAUDE registry was persistent bleeding (48.8% of reports) followed by vessel occlusion (29.6%). These complications were managed successfully using an endovascular approach in 48.4% of the reports.