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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Case details were reviewed.A surgeon reported three manta incidents that occurred over a month ago.In the first case, following a tavr procedure, an 18f manta was unsuccessfully deployed for closure.The interventional cardiologist decided to perform a cutdown (3010252479-2025-00008).In the second case, following a tavr, an 18f manta was unsuccessfully deployed for closure.The interventional cardiologist decided to perform a cutdown (3010252479-2025-00009).In the third case, following a tavr procedure, an 18f manta was unsuccessfully deployed for closure.The interventional cardiologist decided to deploy a covered stent.Due to no further information being provided by the facility or any further response received regarding this complaint, the root cause of the delivery of the implant not being effective in creating hemostasis requiring a covered stent remains undeterminable.Risk documentation has been reviewed and this is a known risk of the device.The manta instructions for use (ifu) lists potential adverse events associated with the deployment of vascular closure devices that have been identified and include other access site complications leading to bleeding, possibly requiring surgical repair, and/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 late arterial bleeding.The ifu precautions if bleeding from the femoral access site persists after the use of the manta device, assess the situation.Based on the amount of bleeding, use manual or mechanical compression, application of balloon pressure, placement of a covered stent, and/or surgical repair to obtain hemostasis.
Event or Problem Description
It was reported that: "surgeon shared 3 cases which manta failed.2 cut down and one stent." associated complaints 3010252479-2025-00008, 3010252479-2025-00009.".
Event or Problem Description
It was reported that: "surgeon shared 3 cases which manta failed.2 cut down and one stent." associated complaints 3010252479-2025-00008, 3010252479-2025-00009 and 3010252479-2025-00010.".
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (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: 73d2401021 manta 18f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.There appears to be no product quality issue concerning manufacturing, documentation, or labelling.The der process will continue to monitor and investigate similar events-no risk evaluation is required as the actual severity does not exceed the expected severity per the risk documentation.

• 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, NC 27560
• MDR Report Key: 21383233
• Report Number: 3010252479-2025-00010
• Device Sequence Number: 8705044
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240423(17)251023(10)73D2401021(21)
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73D2401021
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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 Sex: Unknown