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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "18 fr manta deployed post edwards tavr valve.Large post closure leak from 12mm above femoral arteriotomy.Covered stent deployed to seal leak with good result".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The complaint of hemostasis not being achieved and two covered stents needing to be used could not be confirmed with the investigation of the returned sample.The customer returned one manta dilator and manta closure device.Signs of use in the form of blood particulates were observed on the device.Visual analysis revealed no damage to the device.Unit looked to be deployed as normal with blue lever engaged, collagen deployed, and suture cut.A device history record review was performed, and no relevant findings were identified.Additional information was received that there was mild tortuosity and distal calcium on the access vessel site.Manta was deployed successfully despite minor valve resistance from bypass tube introduction.The leak occurred 12mm above access site that sealed properly with manta.Patient ended up needing a surgical cutdown after covered stents were deployed and a blood transfusion.The instructions for use included in this kit cautions the user, "in the event that bleeding from the femoral access site persists after the use of the manta device, the physician should assess the situation.Based on the physician assessment of the amount of bleeding, use manual or mechanical compression, application of balloon pressure from a secondary access site, placement of a covered stent, and/or surgical repair to obtain hemostasis.".Based on the customer report and sample received, the root cause of this event cannot be determined.Teleflex will continue to monitor and trend for events of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "18 fr manta deployed post edwards tavr valve.Large post closure leak from 12mm above femoral arteriotomy.Covered stent deployed to seal leak with good result".No patient harm or injury.The patient status is reported as "fine".

• 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 27560
• MDR Report Key: 22884875
• Report Number: 3010252479-2025-00082
• Device Sequence Number: 20062478
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)250110(17)260710(10)73A2500358(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2026
• Device Catalogue Number: 2115
• Device Lot Number: 73A2500358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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: N/A.; N/A.
• Patient Sex: Unknown