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	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "patient was undergoing a tavr 26mm valve inside an 18f sheath.Sizing sheet showed ca++ posterior/medial at the mid-distal 1/3 of r femoral head and diameter ~7mm.Dr.(---) used an 8f measuring tool to get just over 6mm (+1).Tavr was performed, manta was introduced and at just over 7cm was deployed, and a 1 minute timer was set to cinch the blue collar and kept pressure on device at green/red.Angio was performed to show partial occlusion; vascular was brought in to assess and decision was made to cut down and repair the rfa with endarterectomy.Repair was successfully performed and patient has no clinical sequela".
Additional Manufacturer Narrative
Qn#(b)(4).No return product evaluation could be completed as the device was not returned for investigation.A centreline ct was obtained, revealing moderate posterior calcification, visibly present.The device lot history record review for lot number 73e2400257 manta 18f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.The case details were reviewed.A 76-year-old female patient, 264 lbs, presented in the or for a tavr procedure.Access was gained utilizing a micropuncture kit with ultrasound for guidance.The right femoral arteriotomy was approximately 7mm in diameter, with moderate medial posterior calcification at 1/3 of the right femoral head, with a measured deployment depth of 6cm + 1cm.No issues were encountered advancing or withdrawing the 18f sentrant sheaths during the case.Following placement of the 26mm evolut fx+ valve, heparin and protamine were administered, and an 18f manta was deployed to the measured depth for closure.A one-minute timer was set to secure the blue lock advancement tube and keep pressure on the device handle at green/red.The post-deployment angiogram performed indicated a partial occlusion.Vascular was called in to assess and decided to cut down, explanted manta, performed an endarterectomy, and successfully repaired the artery.The occlusion's cause requiring surgical intervention likely contributed to user error.Additionally, the manta instructions for use (ifu) posts a warning: do not use if the patient has marked obesity (bmi >40 kg/m2).The ifu also states: deploy device and seal puncture: do not apply compressive or occlusive manual/digital pressure to the vessel while rotating the lever, releasing the anchor, or withdrawing the manta device.Only support the skin enough to prevent distension of the vessel.Continue to withdraw the manta closure until the tension gauge shows yellow/green in the tension window.The blue lock advancement tube will emerge.Note: do not pull past green.Excessive force may cause vessel damage.Only light tension (yellow/green) is required.
Event or Problem Description
It was reported that: "patient was undergoing a tavr 26mm valve inside an 18f sheath.Sizing sheet showed ca++ posterior/medial at the mid-distal 1/3 of r femoral head and diameter ~7mm.Dr.(---) used an 8f measuring tool to get just over 6mm (+1).Tavr was performed, manta was introduced and at just over 7cm was deployed, and a 1 minute timer was set to cinch the blue collar and kept pressure on device at green/red.Angio was performed to show partial occlusion; vascular was brought in to assess and decision was made to cut down and repair the rfa with endarterectomy.Repair was successfully performed and patient has no clinical sequela".

• 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: 21650386
• Report Number: 3010252479-2025-00027
• Device Sequence Number: 18012415
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240508(17)251108(10)73E2400257(21)
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 02/25/2025

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: 11/08/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73E2400257
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2024
• 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: 76 YR
• Patient Sex: Unknown
• Patient Weight: 120 KG