Complications of the MANTA Closure Device: Insights From MAUDE Database.
Complications
Large-bore access
MANTA
Vascular closure devices
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
21
01
2021
revised:
06
02
2021
accepted:
10
02
2021
pubmed:
23
2
2021
medline:
26
3
2022
entrez:
22
2
2021
Statut:
ppublish
Résumé
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. We queried the "Manufacturer and User Facility Device Experience" MAUDE database between February 2019 and December 2020 for reports on MANTA device. 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). 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.
Sections du résumé
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.
Identifiants
pubmed: 33612411
pii: S1553-8389(21)00097-X
doi: 10.1016/j.carrev.2021.02.013
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
75-79Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Santiago Garcia: consultant for Surmodics, Osprey Medical, Medtronic, Edwards Lifesciences, and Abbott. Grant support from Edwards Lifesciences and the VA Office of Research and Development. Emmanouil Brilakis: consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), CSI, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; research support from Regeneron and Siemens. Shareholder: MHI Ventures. Sachin Goel: Speaker's bureau for Abbott Structural Heart. All other authors have nothing to disclose.