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	Extravasation (1842)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "dr.(b)(6) deployed a 18f manta per ifu specks post tvar.During the procedure there was a noted issue with the valve, a second one needed to be used.When an angiogram was taken, we noticed a large blush.A covered stent was needed to complete the procedure.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of extended hemostasis was confirmed by visual inspection of the customer supplied 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.The details of the complaint were reviewed.The patient underwent a transcatheter aortic valve replacement (tavr) via common femoral artery (cfa) access.Ultrasound-guided micro access was obtained on the first attempt.Mild calcification and tortuosity were noted.The measured manta depth was 3+1, and an amplatz wire was used for manta deployment.The anchor was reported to be positioned correctly within the vessel.There were no difficulties advancing or withdrawing sheaths.The patient received both heparin and protamine during the procedure.An issue was encountered with the initial edwards valve, necessitating use of a second valve.Following valve deployment, a large blush was observed at the access site.Medical intervention was required, and a gore covered stent was successfully deployed to manage the issue.Time to hemostasis was approximately 20 minutes.The patient's post-procedure outcome was stable with no reported harm or adverse health consequences.Without the device to evaluate, 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 "dr d.Deployed a 18f manta per ifu specks post tvar.During the procedure there was a noted issue with the valve, a second one needed to be used.When an angiogram was taken we noticed a large blush.A covered stent was needed to complete the procedure.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 PA
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton PA 19341
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23987601
• Report Number: 3010252479-2026-00001
• Device Sequence Number: 18798322
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)240611(17)251211(10)73F2400402(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 12/11/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73F2400402
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2024
• 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: Unknown