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	Obstruction/Occlusion (2422)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "after the tavr procedure the physician went to deploy manta, and performed deployment steps properly, the device was deployed and no blood was present at the skin level.A dsa was taken to show there was a partial blockage of the vessel , with limited flow distally.It was the opinion of the vascular surgeon to cut down.The cardiologist was unable to try and remedy the situation with any other steps.A cut down was performed and when the vs was performing the cut down, doppler pulses were present distal to the manta.The manta was explanted.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after the tavr procedure the physician went to deploy manta, and performed deployment steps properly, the device was deployed and no blood was present at the skin level.A dsa was taken to show there was a partial blockage of the vessel , with limited flow distally.It was the opinion of the vascular surgeon to cut down.The cardiologist was unable to try and remedy the situation with any other steps.A cut down was performed and when the vs was performing the cut down, doppler pulses were present distal to the manta.The manta was explanted.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).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 additional information indicated that the manta was deployed at the measured deployment depth and was positioned correctly in the vessel.No applied compression was observed during anchor deployment.No excessive downward force with the blue lock advancement tube was observed.Immediate hemostasis was achieved.A surgical cutdown was performed, and the manta was explanted.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.

• 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: 23704810
• Report Number: 3010252479-2025-00115
• Device Sequence Number: 10691632
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)250806(17)270206(10)73H2500223(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/11/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2115
• Device Lot Number: 73H2500223
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2025
• 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