MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 14F; VASCULAR CLOSURE DEVICE

Catalog Number	2156
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: 14fr manta used during tavr on (b)(6) 2024 on a cfa with 5.5 diameter.Per verbal communications with the site research coordinator and rep, the puncture site probably was stretched during the procedure and the manta device pulled out of the artery to the subcutaneous tissue tract.The patient went through surgical cutdown.This is being reported for the study as an adverse event and a device deficiency.Additional information received on 21feb2024: pulsatile blood flow from groin.The manta footplate/collagen and lock were in the tissue track not the vessel.This was discovered during the cutdown.Additional information: micro puncture and ultrasound were utilized to gain access in the left common femoral artery.Vessel size was 5.5 per edc 5.6mm.Measured depth for the manta was 3 + 1 =4.Sbp was 136mmhg and act was 175 prior to closure.13000 units of heparin and 25 mg or protamine were administered.Hemostasis was not achieved until the cutdown 57 minutes and 34 seconds after deployment.Successful cutdown and case was completed and there was no reported patient harm or consequence from the incident.
Additional Manufacturer Narrative
(b)(4).There was no device returned for evaluation.The device lot history record review for lot number mn2301556 manta 14f indicated no no n-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.As per the additional information received, the patient bmi was 28.32 kg/m3.Access location was left cfa.Vessel size is 5.5 mm.Vessel factors are unknown.Procedural sheath used was gore dryseal flex.Manta was deployed at 3+1 cm.Customer stated that the puncture site probably stretched, and device was pulled out.However, upon surgical cutdown, the manta was deployed in the tissue and not the vessel.Manta deployed in the tissue would not closure the vessel bore.This leads to bleeding.The ifu states the potential adverse events related to the deployment of vascular closure device are identified as of the following: other access site complications leading to bleeding, hematoma, pseudoaneurysm, or arterio-venous fistula, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.Surgical repair was employed to treat the vessel.Manta was explanted.The case was completed successfully without any issues.A fluoroscopic image was provided.No lock could be noted.The vessel site appears to be narrow with flow noted downstream.The picture likely represents post closure shot after surgical repair.No other information was provided.Based on the information, the most likely root cause of the issue is operational context.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: 14fr manta used during tavr on 20-feb-2024 on a cfa with 5.5 diameter.Per verbal communications with the site research coordinator and rep, the puncture site probably was stretched during the procedure and the manta device pulled out of the artery to the subcutaneous tissue tract.The patient went through surgical cutdown.This is being reported for the study as an adverse event and a device deficiency.Additional information received on 21feb2024: pulsatile blood flow from groin.The manta footplate/collagen and lock were in the tissue track not the vessel.This was discovered during the cutdown.Additional information: micro puncture and ultrasound were utilized to gain access in the left common femoral artery.Vessel size was 5.5 per edc 5.6mm.Measured depth for the manta was 3 + 1 =4.Sbp was 136mmhg and act was 175 prior to closure.13000units of heparin and 25 mg or protamine were administered.Hemostasis was not achieved until the cutdown 57minutes and 34 seconds after deployment.Successful cutdown and case was completed and there was no reported patient harm or consequence from the incident.

• Brand Name: MANTA 14F
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18910577
• Report Number: 3010252479-2024-00039
• Device Sequence Number: 6827354
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: 00856279007079
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/20/2024

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 Catalogue Number: 2156
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female