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	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "partial occlusion at level of closure site caused by dissection flap.Had to do balloon inflation x 2min.Flow restored." additional information : "during a tavr procedure, micro puncture and ultrasound were used to gain central access in the common femoral artery.Vessel size was 5cm.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
Qn# (b)(4).Full udi is not available as the lot# was not provided by the customer.
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.The device lot history record review for lot number 73d2400116 was performed, and no relevant findings were identified.A post angio indicated a partial occlusion caused by a dissection.Balloon inflation was applied, restoring flow.The root cause of the interrupted flow is due to the formation of an occlusive dissection.There was no dog-boning reported during balloon inflation, which indicates the occlusion was most likely due to a dissection rather than the manta implant.Dissections are a common large-bore procedural complication; therefore, it cannot be determined, as it is unclear whether the dissection was created by procedure sheath or the manta device.The potential adverse events associated with any large-bore intervention, may include vascular trauma or laceration.No product quality issues related to manufacturing, documentation, or labeling were identified.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "partial occlusion at level of closure site caused by dissection flap.Had to do balloon inflation x 2min.Flow restored." additional information : "during a tavr procedure, micro puncture and ultrasound were used to gain central access in the common femoral artery.Vessel size was 5cm.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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21080085
• Report Number: 3010252479-2025-00003
• Device Sequence Number: 20913570
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240402(17)251002(10)73D2400116(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: 10/02/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73D2400116
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2024
• 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: 78 YR
• Patient Sex: Unknown
• Patient Weight: 59 KG