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

Catalog Number	2115
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "manta 18fr was used post tavr valve with good result and post image.7 days later pt presented with femoral occlusion requiring surgical intervention to restore flow.Manager reported that surgical consultant said it was a plaque shift in the artery likely not from the manta itself.Occlusion location was not identified.The manta looked like it was in the proper position.There was distal flow and no extravasation.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing of an occlusion seven days after manta placement 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 was received that after the original procedure; there was distal flow and no extravasation.Surgical repair confirmed the occlusion was plaque shift in the femoral and the anchor was partially in the intima of the vessel.The instructions-for-use (ifu) provided with this kit warns the user, "do not use in patients with severe calcification of the access vessel".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: "manta 18fr was used post tavr valve with good result and post image.7 days later pt presented with femoral occlusion requiring surgical intervention to restore flow.Manager reported that surgical consultant said it was a plaque shift in the artery likely not from the manta itself.Occlusion location was not identified.The manta looked like it was in the proper position.There was distal flow and no extravasation.".

• Brand Name: MANTA 18FR
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24531602
• Report Number: 3010252479-2026-00009
• Device Sequence Number: 21418283
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)251010(17)270410(10)73K2500562(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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
• Device Catalogue Number: 2115
• Device Lot Number: 73K2500562
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2025
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown