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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "bleeding from site post deployment.Fluoro revealed extravasation from closure site." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain access in the right common femoral artery.Vessel size was 6.2mm with mild posterior calcification.Measured depth for the manta was 4+1=5.Systolic blood pressure was 160mmhg.Act was 160 prior to valve deployment and additional heparin was given.14000 units of heparin was administered intravenously and 140mg of protamine during the procedure.Time to hemostasis was 10-15 minutes and the site had to be treated with a 6x59 covered stent and 7x40 peripheral angioplasty balloon to achieve hemostasis.The patient was reported as good post the procedure.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.The details of the complaint were reviewed.It is unknown if there was any vessel trauma during sheath exchanges.A device history record review was performed, and no relevant findings were identified.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: "bleeding from site post deployment.Fluoro revealed extravasation from closure site." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain access in the right common femoral artery.Vessel size was 6.2mm with mild posterior calcification.Measured depth for the manta was 4+1=5.Systolic blood pressure was 160mmhg.Act was 160 prior to valve deployment and additional heparin was given.14000units of heparin was administered intravenously and 140mg of protamine during the procedure.Time to hemostasis was 10-15 minutes and the site had to be treated with a 6x59 covered stent and 7x40 peripheral angioplasty balloon to achieve hemostasis.The patient was reported as good 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: 22094489
• Report Number: 3010252479-2025-00053
• Device Sequence Number: 15187434
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(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): 05/05/2025

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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/26/2025
• 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 Age: 87 YR
• Patient Sex: Unknown
• Patient Weight: 62 KG