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

Catalog Number	2115
Medical Device Problem Codes	Obstruction of Flow (2423); Malposition of Device (2616)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "manta 18f closure was used by physician per ifu and patient developed cold leg while in recovery.The event occurred in post-op recovery.Vascular surgery was required to determine why there was no blood flow to the leg.".
Additional Manufacturer Narrative
Qn#(b)(4).The device was not returned for investigation.No return product evaluation could be completed.Teleflex obtained photos.Ct image revealed measurements of the vessel.The second image showed the explanted manta collagen plug (suture, collagen, and anchor).The device lot history record review indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.A 78-year-old, male patient, 73in., 185lb.S, 24.4 bmi, presented in the or for a tavr procedure.A centrally positioned access was achieved utilizing micropuncture with ultrasound for guidance.The right common femoral arteriotomy (rcfa) was 7.5+cm, with mild calcification noted in the lower third of the femoral head, anterior wall calcification, with a measured deployment depth of 3.5mm + 1mm.No issues were encountered advancing or withdrawing the 16f expandable procedural sheath during the case.Before closure, activated clotting time (act) was below 250, heparin and protamine were administered, and an 18f manta was deployed to the measured depth.Hemostasis was immediate, and the patient was transferred to recovery.While in recovery, the patient developed a cold leg and a loss of pulses.The vascular surgeon was called in for surgical intervention.During the cut-down, the manta anchor was seen malpositioned and a dissection was obstructing flow.The manta device was explanted, and the vessel was repaired.Dissections are a common event in large bore procedures.It is inconclusive if the dissection was caused during the procedure or by the manta device.Therefore, the root cause of the occlusion requiring surgical intervention is likely contributed to a dissection resulting in ischemia present at the access site potentially disrupting the proper placement of the manta anchor.The device was not returned, there is believed to be no device failure.Risk documentation has been reviewed , and occlusion is a known device risk.The patient did not experience any health consequences from this event and the outcome post-procedure is fine.The manta instructions for use (ifu) lists potential adverse events related to the deployment of vascular closure devices including ischemia of the leg or stenosis of the femoral artery; local trauma to the femoral or iliac artery wall, such as dissection and other access site complications leading to bleeding, hematoma, pseudoaneurysm, etc., possibly requiring blood transfusion, surgical repair, or endovascular intervention.Potential adverse events associated with any large bore intervention, including the use of the manta vascular closure device, include but are not limited to vessel laceration or trauma.There appears to be no product quality issue concerning manufacture, documentation, or labeling.The der process will continue to monitor and investigate any similar events.No risk evaluation is required as the actual severity does not exceed the expected severity per the risk documentation.
Additional Manufacturer Narrative
(b)(4).Imdrf bcd codes updated.
Event or Problem Description
It was reported that "manta 18f closure was used by physician per ifu and patient developed cold leg while in recovery.The event occurred in post-op recovery.Vascular surgery was required to determine why there was no blood flow to the leg.".

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 21406424
• Report Number: 3010252479-2025-00011
• Device Sequence Number: 20891726
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240423(17)251023(10)73D2401024(21)
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/24/2025

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: 10/23/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73D2401024
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2024
• 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.
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG