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

Catalog Number	2115
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Ischemia (1942); Reduced Blood Flow (4598)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "just notified of vascular complication, patient developed foot drop (r) post op immediate or pod 1.On pod 2 developed acute limb ischemia (r).Underwent thrombectomy on 10/18 (r)sfa underwent hematoma excavation on 10/20.".
Additional Manufacturer Narrative
(b)(4).Correction to section d: udi number.Additional information: no return product evaluation could be completed as the device was not returned for investigation.The device lot history record review for lot number 73b2400960 manta 18f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.Following a tavr procedure, an 18f manta was deployed for closure.Post-op day one the patient developed a foot drop on the right side.On post-op day two the patient developed acute limb ischemia of the right side.The patient was transferred to surgery for a thrombectomy of the right superficial artery.Post-op day four the patient underwent a hematoma excavation; the patient outcome post-procedure was fine.Without the device to evaluate, the probable root cause could not be determined from the available information.There appears to be no product quality issue concerning manufacturing, documentation, or labelling.The der process will continue to monitor and investigate any similar events.
Event or Problem Description
It was reported that: "just notified of vascular complication, patient developed foot drop (r) post op immediate or pod 1.On pod 2 developed acute limb ischemia (r).Underwent thrombectomy on 10/18 (r)sfa underwent hematoma excavation on 10/20.".

• Brand Name: 18F MANTA
• 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: 20721565
• Report Number: 3010252479-2024-00183
• Device Sequence Number: 6471554
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240227(17)250827(10)73B2400960(21)
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/25/2024

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: 08/27/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73B2400960
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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