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

Catalog Number	2115
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/15/2025
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.Case details were reviewed.A seventy-five-year-old male patient (124.5kgs., 274.47lbs.), presented in the or for a tavr procedure.Mid-positioned access was gained by utilizing a micropuncture kit with ultrasound for guidance.The right common femoral arteriotomy was 8.6mm, clear of calcification and tortuosity, with a measured deployment depth of 4.5cm + 1cm.Issues were encountered advancing and withdrawing the 14f expandable procedural sheath and manta sheath, due to the presence of copious scare tissue.Following the tavr, an 18f manta was deployed to the measured deployment depth, and hemostasis was less than five minutes.A post-deployment angiography revealed an occlusion in the vessel.The vascular surgeon was called in for surgical intervention.During the cut-down procedure, the surgeon found that the entire manta device had been deployed intraarterially.The manta device was explanted, and the vessel was repaired.The patient did not experience any harm, injury, or health consequences due to this event, and the outcome post-procedure was fine.The root cause of the delivery of the implant not being effective in creating hemostasis requiring surgical cutdown is due to user error in deploying the entire manta device intravascular.Numerous causes for intraarterial deployment have been established.However, the exact reason for this intraarterial deployment is potentially due to user error.The severity of harm is ranked as a 3 due to surgical intervention being used as a treatment to achieve hemostasis.The manta instructions for use (ifu) lists potential adverse events related to the deployment of vascular closure devices including ischemia of the leg or stenosis of the femoral artery, and other access site complications leading to bleeding, possibly requiring surgical repair and endovascular intervention.
Event or Problem Description
It was reported that: "manta deployed inside vessel and cutdown performed to remove manta and close vessel.".
Additional Manufacturer Narrative
Qn#(b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (b)(4).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.
Event or Problem Description
It was reported that: "manta deployed inside vessel and cutdown performed to remove manta and close vessel.".

• 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: 21320033
• Report Number: 3010252479-2025-00006
• Device Sequence Number: 21006598
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240305(17)250905(10)73C2400113(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/15/2025

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 Catalogue Number: 2115
• Device Lot Number: UNKNOWN
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Sex: Unknown
• Patient Weight: 124 KG