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 Codes	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "footplate got wedged into the vessel and when the physician was trying to get a wire past to balloon he caused a dissection and a perforation.Cutdown was performed and a patch was placed." additional information received on 18oct2024: "micro puncture and ultrasound were utilized to gain access in the right common femoral artery.Vessel size was 8mm with no reported calcification or tortuosity.Measured depth for the manta was 6+1cm.Both heparin and protamine were administered during the procedure.The dissection was caused by the physician trying to get a wire past where the obstruction was - which the obstruction was caused by the foot plate.The obstruction was the manta foot plate that was not flush against the arteriotomy.".
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 73b2400587 manta 18f indicated no non-conformities related to this lot.No impact related to the device, no reworks, or other issues related, therefore, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.Following the tavr, an 18f manta was deployed to the measured depth, and hemostasis was immediate.A post-deployment angiography revealed an obstruction in the vessel.The manta anchor appeared partially lodged in the vessel wall and was not flush.The physician attempted to get a wire past the obstruction, causing a dissection and perforation.Balloon angioplasty was applied, and the decision was made to intervene surgically.The vascular surgeon explanted the manta device and patch-repaired the vessel.The vascular surgeon noted the access was high.High-access sites are listed as contraindications to the manta device due to the possibility of not achieving an optimal seal and causing more difficulty in controlling bleeding.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 user error in deploying the manta device partially into the vessel wall.Numerous causes for intraarterial deployment have been established.However, the exact reason for this intraarterial deployment is potentially due to user error.
Event or Problem Description
It was reported that: "footplate got wedged into the vessel and when the physician was trying to get a wire past to balloon he caused a dissection and a perforation.Cutdown was performed and a patch was placed." additional information received on 18oct2024: "micro puncture and ultrasound were utilized to gain access in the right common femoral artery.Vessel size was 8mm with no reported calcification or tortuosity.Measured depth for the manta was 6+1cm.Both heparin and protamine were administered during the procedure.The dissection was caused by the physician trying to get a wire past where the obstruction was - which the obstruction was caused by the foot plate.The obstruction was the manta foot plate that was not flush against the arteriotomy.".

• 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: 20568400
• Report Number: 3010252479-2024-00179
• Device Sequence Number: 12645320
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240214(17)250819(10)73B2400587(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,Followup
• Report Date (Section B): 10/14/2024

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: 08/19/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73B2400587
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2024
• 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: Female