Real-World Experience of the MANTA Closure Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.
Real-World Experience of the MANTA Closure Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.
- 2021
Available in print through MWHC library: 2002 - present
BACKGROUND/PURPOSE: The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania). CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD. Copyright (c) 2020. Published by Elsevier Inc. METHODS/MATERIALS: Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports. RESULTS: Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1).
English
1878-0938
10.1016/j.carrev.2020.11.023 [doi] S1553-8389(20)30773-9 [pii]
*Vascular Closure Devices
Databases, Factual
Femoral Artery
Hemorrhage/et [Etiology]
Humans
Treatment Outcome
United States
United States Food and Drug Administration
MedStar Heart & Vascular Institute
Journal Article
Available in print through MWHC library: 2002 - present
BACKGROUND/PURPOSE: The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania). CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD. Copyright (c) 2020. Published by Elsevier Inc. METHODS/MATERIALS: Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports. RESULTS: Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1).
English
1878-0938
10.1016/j.carrev.2020.11.023 [doi] S1553-8389(20)30773-9 [pii]
*Vascular Closure Devices
Databases, Factual
Femoral Artery
Hemorrhage/et [Etiology]
Humans
Treatment Outcome
United States
United States Food and Drug Administration
MedStar Heart & Vascular Institute
Journal Article