MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 18F; VASCULAR CLOSURE DEVICE

Catalog Number	2115
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "manta 18f deployed to right femoral artery post tavr procedure.Upon selective contrast injection to right femoral artery, complete occlusion noted at deployment site of manta.Ct surgeon performed a cutdown to right femoral artery.Upon cutting out manta closure device, the suture, radiopaque marker and collagen were retrieved, but the footplate was not obtained.Physician repaired vessel and distal pulses were present via doppler to right lower extremity." additional information: " upon the cut down, the collagen appeared to be deployed extra vascular per the ct surgeon.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.The device lot history record review for lot number 73d2400116 manta 18f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.Case details were reviewed.Post tavr procedure, a contrast injection of the right femoral artery indicated an obstruction of flow causing a complete occlusion at the access site.The cardio-thoracic surgeon was called in and performed a cutdown.The manta device, suture, collagen, and radiopaque marker were explanted during the surgical intervention, but the anchor was not obtained.The manta anchor was seen positioned within the vessel, and according to the surgeon, the collagen appeared to have been deployed extravascular.Therefore, the root cause of the occlusion requiring endovascular intervention is likely attributed to user error due to the manta anchor being deployed malpositioned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "manta 18f deployed to right femoral artery post tavr procedure.Upon selective contrast injection to right femoral artery, complete occlusion noted at deployment site of manta.Ct surgeon performed a cutdown to right femoral artery.Upon cutting out manta closure device, the suture, radiopaque marker and collagen were retrieved, but the footplate was not obtained.Physician repaired vessel and distal pulses were present via doppler to right lower extremity." additional information: " upon the cut down, the collagen appeared to be deployed extra vascular per the ct surgeon.".

• Brand Name: MANTA 18F
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21409920
• Report Number: 3010252479-2025-00013
• Device Sequence Number: 9318014
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240402(17)251002(10)73D2400116(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73D2400116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 108 KG