Complications of the MANTA closure device. Insights from MAUDE database

Michael Megaly, Ramy Sedhom, Peter Abdelmaseeh, Bishoy ElBebawy, Sachin S. Goel, Joseph Karam, Ashish Pershad, Emmanouil S. Brilakis, Santiago Garcia

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalCardiovascular Revascularization Medicine
DOIs
StateAccepted/In press - 2021

Keywords

  • Complications
  • Large-bore access
  • MANTA
  • Vascular closure devices

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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