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

Catalog Number 2115

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Extravasation (1842); Obstruction/Occlusion (2422)

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that: small blushing with partial vessel occlusion.Ballooned x5 minutes.Additional information received on 11dec2023: physicain initially could not feel a good pulse distal to manta post deployment.Post angio showed partial occlusion in the vessel.No harm, patient was fine, hemostasis achieved.

Manufacturer Narrative

Qn#(b)(4) no return product evaluation could be completed as the device was not returned for investigation.Angiography photos were obtained by vsi/teleflex revealing a mid-femoral head positioned access.Radiopaque lock distal to the bifurcation.Partial occlusion with an interruption in flow past the radiopaque lock.Balloon inflation applied with good flow return.The device lot history record review for lot number mn2301532 manta 18f indicated during lot release of manta lot (mn2301532) two devices exhibited a failure of the collagen deployment specification.No other non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.Case details were reviewed.A 78-year-old female patient (151lbs) presented in the or for a tavr procedure whereas an 18f manta was utilized for closure.Following deployment, blushing was present, and the physician was unable to detect a good pulse distal to manta post-deployment.An angiogram indicated a partial occlusion within the vessel.Balloon angioplasty was applied for four to five minutes, and a post-angiogram indicated hemostasis was achieved.The total time to hemostasis was less than ten minutes.The patient did not experience any harm, injury, or health consequences from this event, and the outcome post-procedure was fine.Numerous causes for intraarterial deployment have been established.According to the post-ma nta deployment angiogram, the radiopaque lock appears positioned distal to the bifurcation.The manta instructions for use warns not to use manta if the puncture site is at or distal to the bifurcation of the superficial femoral and profundal femoris artery, as this may result in the 1) anchor catching on the bifurcation or being positioned incorrectly, and/or 2) collagen deposition into the vessel.Therefore, the root cause of the intraarterial deployment (occlusion) is potentially due to user error.The ifu precautions if bleeding from the femoral access site persists after the use of the manta device, assess the situation.Based on the amount of bleeding, use manual or mechanical compression, application of balloon pressure from a secondary access site, placement of a covered stent, and/or surgical repair to obtain hemostasis.The ifu lists potential adverse events related to the deployment of vascular closure devices including ischemia of the leg or stenosis of the femoral artery and other access site complications leading to bleeding, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.Potential adverse events associated with any large bore intervention, including the use of the manta vascular closure device, include but are not limited to late arterial bleeding.The severity of harm is ranked as a 4 based on the event of ballooning utilized to treat the occlusion at the vessel access site arteriotomy.There appears to be no product quality issue with respect to manufacturing, documentation, or labelling.The der process will continue to monitor and investigate any similar events.

Event Description

It was reported that: small blushing with partial vessel occlusion.Ballooned x5 minutes.Additional information received on 11dec2023 physicain initially could not feel a good pulse distal to manta post deployment.Post angio showed partial occlusion in the vessel.No harm , patient was fine, hemostasis achieved.

• Brand Name: 18F MANTA VASCULAR CLOSURE DEVICE
• Type of Device: 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: 18424085
• MDR Text Key: 332293724
• Report Number: 3010252479-2024-00001
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: 00856279007062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2115
• Device Lot Number: MN2301532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 68 KG