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 journalArticlepeer-review

5 Scopus citations

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)
Pages (from-to)75-79
Number of pages5
JournalCardiovascular Revascularization Medicine
Volume34
DOIs
StatePublished - Jan 2022
Externally publishedYes

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint

Dive into the research topics of 'Complications of the MANTA Closure Device: Insights From MAUDE Database'. Together they form a unique fingerprint.

Cite this