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

Catalog Number	2115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: " during a tavr procedure ultrasound and micropuncture were utilized to gain central acces in the left common femoral artery.Vessel size was 6.5mm with no reported clacification or tortuosity.Measured depth for the manta was 2+1cm.Post deployment, dissection at manta site- ballooned to restore flow.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).The customer report of vessel damage/dissection was confirmed by visual inspection of the customer supplied photo and videos.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Additional information indicated that a transcatheter aortic valve replacement (tavr) was being performed.The procedure sheath was a 14fr edwards esheath.No issues with advancing or withdrawing procedure sheaths during the case.The artery access location was the left common femoral artery (cfa), and the vessel size was 6.5mm.The cfa access location was central.A micropuncture kit was used to gain access with ultrasound, and only one attempt was needed.There was no calcification or tortuosity.The manta was deployed at the measured deployment depth of 2+1cm.Time to hemostasis was immediate.Medical intervention was required in the form of balloon angioplasty.No blood transfusion was performed.The manta was deployed on a soft j-wire exchanged prior to deployment.It is unknown if the reported dissection was caused by the procedural sheath or the manta sheath.Per the customer, it is unclear if the anchor was positioned correctly in the vessel.The collagen was not deployed within the vessel.The issue was resolved with a balloon angioplasty procedure.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: " during a tavr procedure ultrasound and micropuncture were utilized to gain central access in the left common femoral artery.Vessel size was 6.5mm with no reported calcification or tortuosity.Measured depth for the manta was 2+1cm.Post deployment, dissection at manta site- ballooned to restore flow.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: 23476271
• Report Number: 3010252479-2025-00109
• Device Sequence Number: 10329529
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)240605(17)251205(10)73F2400237(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 12/05/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73F2400237
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2024
• 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 Age: 88 YR
• Patient Sex: Female
• Patient Weight: 64 KG