Complications of the MANTA closure device. Insights from MAUDE database.


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Complications of the MANTA closure device. Insights from MAUDE database.

Cardiovasc Revasc Med. 2021 Feb 15;:

Authors: Megaly M, Sedhom R, Abdelmaseeh P, ElBebawy B, Goel SS, Karam J, Pershad A, Brilakis ES, Garcia S

Abstract
BACKGROUND: The 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.
METHODS: We queried the “Manufacturer and User Facility Device Experience” MAUDE database between February 2019 and December 2020 for reports on MANTA device.
RESULTS: We 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).
CONCLUSIONS: The 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.

PMID: 33612411 [PubMed – as supplied by publisher]

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