MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 14F; VASCULAR CLOSURE DEVICE

Catalog Number	2156
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for investigation.No return product evaluation could be completed.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.An 84-year-old male patient, (69.4kg, 170.2cm, 23.96kgs/m2) presented in the or for a tavr procedure.Access was gained utilizing ultrasound for guidance.The left common femoral arteriotomy had a measured deployment depth of 4.0cm.No issues were encountered advancing or withdrawing the procedural sheath during the case.Following the tavr procedure, heparin and protamine were administered, and a 14f manta device was deployed for closure.Following deployment, a doppler examination indicated peddle pulses were absent.A peripheral angiography revealed a distal dissection and evidence of thrombosis.Dissections are a common event in large bore procedures.It is inconclusive if the dissection was caused during the procedure, or by the manta closure device.The vascular surgeon was called in and performed a left femoral artery thrombectomy.The patient regained pulses to the lower left extremity and was transferred to a skilled nursing facility.There appears to be no product quality issue concerning manufacturing, 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.
Event or Problem Description
The report states: "14f manta vascular closure device was deployed in left femoral access site.Post deployment pedal pulses were absent under doppler exam.Peripheral angiography revealed distal dissection and evidence of thrombi.Cardiovascular operating room and vascular surgery notified and in room for intervention.".
Event or Problem Description
The report states: "14f manta vascular closure device was deployed in left femoral access site.Post deployment pedal pulses were absent under doppler exam.Peripheral angiography revealed distal dissection and evidence of thrombi.Cardiovascular operating room and vascular surgery notified and in room for intervention.".
Additional Manufacturer Narrative
Qn# (b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (b)(4).

• Brand Name: MANTA 14F
• 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: 21409183
• Report Number: 3010252479-2025-00012
• Device Sequence Number: 8244713
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)231010(17)250402(10)MN2301556(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): 01/28/2025

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: 04/30/2025
• Device Catalogue Number: 2156
• Device Lot Number: MN2301556
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 69 KG