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

Catalog Number	2115
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).Udi will be provided with the follow up report.
Event or Problem Description
It was reported that "manta anchor caught on calcium, not allowing full opposition to vessel.Manta pgla anchor diminished flow to sfa and profunda.Balloon angioplasty attempted with no success.Cutdown performed on left fa.Manta device fully recovered and flow restored." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the left common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.Measured depth for the manta was 4.5+1.Systolic bp was 130 and act was 238.Heparin was given during the procedure.The entire manta was removed during the cutdown and the patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.The device lot history record review for lot number 73e2400582 manta 18f indicated no non-conformities related to this lot, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.Post-tavr, an 18f manta was deployed to the measured depth for closure.During the deployment, the manta anchor caught on a piece of calcium and became malpositioned.The anchor could not fully adhere to the vessel wall due to the presence of plaque.Balloon angioplasty was attempted, although not successfully, and the physician decided to surgically intervene.The manta device was explanted, the vessel was repaired, sutured for closure, and flow was restored.The patient did not experience any harm, injury, or health consequences from 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 intervention, is likely contributed to user error, due to poor patient selection, since the vessel was calcified.
Event or Problem Description
It was reported that "manta anchor caught on calcium, not allowing full opposition to vessel.Manta pgla anchor diminished flow to sfa and profunda.Balloon angioplasty attempted with no success.Cutdown performed on left fa.Manta device fully recovered and flow restored." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the left common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.Measured depth for the manta was 4.5+1.Systolic bp was 130 and act was 238.Heparin was given during the procedure.The entire manta was removed during the cutdown and the patient was reported as fine post the procedure.".

• 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: 21857018
• Report Number: 3010252479-2025-00041
• Device Sequence Number: 11941896
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240515(17)251115(10)73E2400582(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): 03/27/2025

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: 11/15/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73E2400582
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2024
• 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; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown