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

Catalog Number	2115
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "manta deployed per ifu in right femoral artery post evar procedure.Upon assessment of tibial and pedal pulses, pulses were absent on right foot.Ultrasound performed, flow to vessel was limited distal to manta closure device.Physician proceeded with cutdown to repair vessel; grafted vessel sutured in place.".
Additional Manufacturer Narrative
Qn# (b)(4).No return product evaluation could be completed as the device was not returned for investigation.A device lot history record review for lot number 73b2400749 manta 18f ce was performed and no relevant findings were identified.Case details were reviewed.Post-evar, an 18f manta was deployed in the right femoral artery for closure.Post-deployment tibial and pedal pulse assessment indicated no flow in the right foot.An ultrasound indicated limited flow distal to the manta access site.The physician chose to perform a cut-down, grafted the vessel, and sutured it in place.The root cause of occlusion requiring local surgical repair, could not be determined could not be determined from the available information.
Event or Problem Description
It was reported that: "manta deployed per ifu in right femoral artery post evar procedure.Upon assessment of tibial and pedal pulses, pulses were absent on right foot.Ultrasound performed, flow to vessel was limited distal to manta closure device.Physician proceeded with cutdown to repair vessel, grafted vessel sutured in place.".

• 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: 20459636
• Report Number: 3010252479-2024-00171
• Device Sequence Number: 20782064
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240220(17)250820(10)73B2400749(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): 10/03/2024

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: 08/20/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73B2400749
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• 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: 71 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG