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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi will be added with the follow up report.
Event or Problem Description
It was reported that: "incomplete hemostasis and vessel extravasation under fluoroscopy." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.Measured depth for the manta was 3+1=4.Systolic blood pressure was 153 and act was 243.12k heparin and 100mg of protamine were administered intravenously during the procedure.Peripheral angioplasty balloon and stent was applied to treat extravasation and incomplete homeostasis.Time to hemostasis was 10-15 minutes and patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4) no return product evaluation could be completed as the device was not returned for investigation.A device history record review was performed, and no relevant findings were identified.Case details were reviewed.Following the tavr, activated clotting time measured 243 sec, heparin and protamine were administered, and the 18f manta was deployed to the measured depth.A post-deployment fluoroscopy revealed vessel extravasation.Balloon angioplasty was applied to tamponade, and a gore viabahn covered stent was deployed to address the bleed.The patient's outcome post-procedure was fine.Without the device to evaluate, the probable root 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: "incomplete hemostasis and vessel extravasation under fluoroscopy." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.Measured depth for the manta was 3+1=4.Systolic blood pressure was 153 and act was 243.12k heparin and 100mg of protamine were administered intravenously during the procedure.Peripheral angioplasty balloon and stent was applied to treat extravasation and incomplete homeostasis.Time to hemostasis was 10-15 minutes and 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21879775
• Report Number: 3010252479-2025-00042
• Device Sequence Number: 8641317
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240515(17)251115(10)73E2400582(21)
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/31/2025

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: 11/15/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73E2400582
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2024
• 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
• Patient Weight: 74 KG