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

Model Number 2115

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Extravasation (1842)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.

Event Description

It was reported that: extravasation post manta closure with bailout out steps included: manual pressure x10 min, ballooning, covered stent placed.Still extravasation noted on angio.Pt taken to surgery where surgeon reported no bleeding , but manta was explanted from vessel.Additional information on 30mar2023: during a tavr procedure, micro puncture and ultrasound were utilized to gain single access in the lower third of the right common femoral artery.Vessel size was 7.5mmx8.7mm.It was unknown if the vessel was calcified but there was no reported tortuosity.There were no issues advancing or withdrawing procedural sheaths.After deployment of the manta the time to hemostasis was immediate on the surface but an angiogram revealed an extravasation manual pressure x10 minutes was held, the site was ballooned, covered stent placed but extravasation remained on an angiogram.The patient was taken to surgery where the surgeon reported no bleeding , but manta was explanted from vessel.The physician's opinion was that the extravasation was caused by vessel perforation and that the manta had not contributed to the event.The patient was reported as fine and stable post the event.

Manufacturer Narrative

(b)(4).The device was not returned for investigation.No return product evaluation could be completed.Angiograms were obtained by vsi and indicated extravasation superior to the access site with slight narrowing proximal to the access.A covered stent was placed, but extravasation was still present.The device lot history record review indicated during lot release of this lot of manta a single device 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.Based on the information submitted, following a tavr procedure, an 18f manta was deployed for closure in the right common femoral artery; the arteriotomy measured 7.5mm x 8.7mm.The patient was 5ft.5 in., weighing 128 pounds with a bmi of 21.3.The manta instructions for use warns not to use manta in patients having marked cachexia (bmi <20 kg/m2).Low-positioned access was gained utilizing micropuncture and ultrasound guidance.No issues were encountered advancing or withdrawing the procedural sheaths.The manta device was deployed to the measured depth, and hemostasis was immediate on the surface.A post-procedure angiogram indicated extravasation, manual pressure was applied for ten minutes, balloon angioplasty was deployed to tamponade, and a covered stent was placed to address the bleeding.A follow-up angiogram continued to indicate extravasation, and the patient was transferred to surgery.During surgical intervention, the surgeon reported the manta device was explanted, no bleeding was present , and the patient outcome post-procedure was stable.The surgeon expressed that the extravasation requiring surgical intervention was likely contributed to a vessel perforation and not from the manta deployment.The device was not returned, there is believed to be no device failure.Risk documentation has been reviewed and this is a known risk of the device.The following potential adverse events associated with the deployment of vascular closure devices have been identified in the manta instructions for use and include perforation of iliofemoral arteries causing bleeding/hemorrhage and other access site complications leading to bleeding, possibly requiring 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 arterial damage, vessel laceration or trauma, and late arterial bleeding.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, placement of a covered stent, and/or surgical repair to obtain hemostasis.

Event Description

It was reported that: extravasation post manta closure with bailout out steps included: manual pressure x10 min, ballooning, covered stent placed.Still extravasation noted on angio.Pt taken to surgery where surgeon reported no bleeding , but manta was explanted from vessel.Additional information on (b)(6) 2023: during a tavr procedure, micro puncture and ultrasound were utilized to gain single access in the lower third of the right common femoral artery.Vessel size was 7.5mmx8.7mm.It was unknown if the vessel was calcified but there was no reported tortuosity.There were no issues advancing or withdrawing procedural sheaths.After deployment of the manta the time to hemostasis was immediate on the surface but an angiogram revealed an extravasation manual pressure x10 minutes was held, the site was ballooned, covered stent placed but extravasation remained on an angiogram.The patient was taken to surgery where the surgeon reported no bleeding , but manta was explanted from vessel.The physician's opinion was that the extravasation was caused by vessel perforation and that the manta had not contributed to the event.The patient was reported as fine and stable post the event.

• Brand Name: MANTA 18F
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16759840
• MDR Text Key: 313485922
• Report Number: 3010252479-2023-00071
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2115
• Device Catalogue Number: 2115
• Device Lot Number: MN2201469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 58 KG