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

Catalog Number	2115
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "tavr case.Physician got access with mik and ultrasound.Puff of contrast showed he was in a dissection plane.Removed mik, held pressure and re-stuck a second time with mik and ultrasound.Pre femoral angio was in true lumen, proceeded with tavr case.No issues advancing sheaths.When the valve entered through e-sheath, patient became irritable and was in pain.Continued with the tavr procedure.Physician was concerned about the dissection from the initial stick, so he took an angio with the sheath pulled back to the femoral.Sheath was occlusive.Physician removed e-sheath and closed with manta.When physician took the angio post manta, the vessel was occluded from iliac to distal to the manta closure.Physician consulted vascular surgery.Cut down was performed and the manta device was removed in its entirety.The patient was stable post the procedure.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The details of the complaint were reviewed.It is likely that the dissection or vessel factors caused by the initial stick and/or the e-sheath could have led to occlusion.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "tavr case.Physician got access with mik and ultrasound.Puff of contrast showed he was in a dissection plane.Removed mik, held pressure and re-stuck a second time with mik and ultrasound.Pre femoral angio was in true lumen, proceeded with tavr case.No issues advancing sheaths.When the valve entered through e-sheath, patient became irritable and was in pain.Continued with the tavr procedure.Physician was concerned about the dissection from the initial stick, so he took an angio with the sheath pulled back to the femoral.Sheath was occlusive.Physician removed e-sheath and closed with manta.When physician took the angio post manta, the vessel was occluded from iliac to distal to the manta closure.Physician consulted vascular surgery.Cut down was performed and the manta device was removed in its entirety.The patient was stable 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: 22042511
• Report Number: 3010252479-2025-00051
• Device Sequence Number: 8781899
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240515(17)251115(10)73E2400582(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 04/30/2025

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?: 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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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 Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 109 KG