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Complications of the MANTA Closure Device: Insights From MAUDE Database
Michael Megaly1, Ramy Sedhom2, Peter Abdelmaseeh2
1Division of Cardiology, Banner University Medical Center, University of Arizona, Phoenix, AZ, USA.
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.
Insights
The collagen-based MANTA device for large-bore vascular access closure can cause persistent bleeding and vessel occlusion. While endovascular approaches often succeed, some cases require surgery.
Area of Science:
- Vascular Surgery
- Medical Device Safety
- Interventional Cardiology
Background:
- The MANTA device is a collagen-based system for closing large-bore vascular access sites.
- Real-world data on MANTA device complications are limited.
Purpose of the Study:
- To analyze complications associated with the MANTA device using real-world data.
- To identify common failure modes and management strategies for MANTA device-related adverse events.
Main Methods:
- A retrospective analysis of the Manufacturer and User Facility Device Experience (MAUDE) database.
- Inclusion of reports on the MANTA device from February 2019 to December 2020.
Main Results:
- 250 reports identified, with persistent bleeding (48.8%) and vessel occlusion/stenosis (29.6%) being most frequent complications.
- Endovascular management was successful in 48.4% of cases; 40.4% required surgical intervention.
- Common failure mechanisms included deployment failure (22%) and subcutaneous deployment (7.6%).
- The 18 Fr. MANTA showed higher rates of vessel occlusion/stenosis and thrombosis compared to the 14 Fr. device.
Conclusions:
- Persistent bleeding and vessel occlusion are the primary complications of the MANTA device.
- Endovascular treatment is effective for many MANTA device complications, but surgical intervention remains necessary in a significant proportion of cases.
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