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

Catalog Number	2156
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Reduced Blood Flow (4598)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "manta deployed during evar case.Left sided manta to close a 12f sheath.Vessel was 7.6mm and calcified.Post deployment there was excessive bleeding.Manta "redeployed" at steeper angel.No change in bleeding.Angio taken but due to bleeding physician was unable to remove pressure from access site.Md made decision to hold manual pressure for 40 minutes total.Post pressure there was no bleeding present, no hematoma, and doppler distal pulse to access site.Check on patient on (b)(6) 2025 site appeared within normal limits.Blood pressure was 90s/60s.There was reportedly tortuosity in iliac bilaterally.Measured depth for manta was 2.5+1.4000 units of heparin and 50mg or protamine was given during the procedure.The patient needed 1 unit of blood transfused.Received message today explaining that the left foot had become mottled and patient taken to or.Manta removed from within artery.Secondary procedure to remove manta occlusion on (b)(6) 2025.Additional information: following an evar performed on (b)(6) 2025 a teleflex manta closure device was inserted into the left common femoral artery, with the patient having heavily calcified vessels the footplate of the device and the closure material both caught on the calcium deploying the manta device but still observing bleed back.Manual pressure was held, and hemostasis was obtained.Post-op pulses were obtained and followed daily (b)(6) 2025 at a +2 femoral/popliteal/ ds + dp/pt.No hematoma was present any of those days.It was stated on the patient examination on (b)(6) 2025 that his left 1st toe had discoloration present.On (b)(6) 2025 a ct abd/pelvis with iv contrast was performed to evaluate aaa post op.At this time, it was noted that the left sided closure device foot plate was more situated centrally in the artery as opposed to against the anterior wall.The physician determined it was in the patient's best interest once cleared from icu to proceed to the operating room to remove the manta closure device, though on the ct the contrast passed the common femoral artery without hesitation it was high likelihood for thrombus to form at closure device site.On (b)(6) 2025 a left common femoral artery endarterectomy was performed and closure device was removed.

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22201499
• Report Number: 3010252479-2025-00061
• Device Sequence Number: 6765046
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)241015(17)260415(10)73K2400551(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 05/20/2025

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: 04/15/2026
• Device Catalogue Number: 2156
• Device Lot Number: 73K2400551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown