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

Model Number 2115

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(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: the patient overweight and the belly had to be taped up prior to the tavi procedure.Access was made on the right cfa but with a lot of difficulty as the track was more on a horizontal plane and the introducers had go to through lots of tissue.Nonetheless, they decided to use manta and the depth location was made without any issue at 6+1=7cm.After the tavi all the proper steps to deploy the manta 18f were performed properly right up to the advancement of the radio opaque marker.At this point there was still arterial bleeding.They decided to inflate a 9mmx40cm balloon at the puncture site through the contralateral access.After 5 minutes of inflation, there was still arterial bleed at deflation of the balloon.They elected to deploy an 10mmx59mm covered stent through the contralateral access.Bleeding immediately stopped at skin level and no extravasation was seen on the control angio.The operator does not blame the manta device, but a challenging case with a less than optimal access.Additional information: "the radiopaque marker on post procedural contralateral femoral angiogram seemed to be positioned far from the artery.As if, there was tissue caught between the marker and the artery, which would explain the closure failure.There was pulsatile blood flow from the site post manta deployment.The operator applied manual pressure to stop the bleeding while preparing the interventions from the contralateral side.Blood loss not significant to have a blood transfusion.All vital signs of the patient remained stable during the management of the site." the patient was reported as fine post procedure.

Manufacturer Narrative

Qn# (b(6).The device was not returned for investigation.No return product evaluation could be completed.The device lot history record review indicated no 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 tavi procedure, an 18f manta was deployed for closure in the right common femoral artery.Due to the patient's body habitus, bmi potentially being out of range, and a large pannus having to be taped prior to the deployment, this patient was noted as less than ideal for the manta vascular closure device.Prior to deployment, complications were experienced attempting to achieve access in the right femoral artery.The measured depth was 6cm + 1cm, although the access tract was positioned more horizontally, and the introducers had to go through a lot of tissue.Following deployment, arterial bleeding was present, immediate manual pressure was held, and contralateral balloon inflation was applied for five minutes, although arterial bleeding continued.A post-procedure contralateral angiogram revealed an unsuccessful closure.The radiopaque lock appeared to be distant from the puncture as though tissue was caught between the lock and the artery.The physician decided to deploy a covered stent through the contralateral access.Hemostasis was immediate on the skin surface and a follow-up post-angiogram indicated no extravasation.The cause of the unsuccessful closure and uncontrolled bleeding is tract deployment.The root cause of the tract deployment is likely due to the less-than-ideal patient conditions.The patient presented with a pannus that had to be taped back.If the pannus was moved or pulled back, it likely created deeper access which altered the deployment depth for manta.The instructions for use post warnings not to use manta if the patient has marked obesity (bmi >40 kg/m2).However, it is inconclusive for this event due to insufficient information regarding the initial and deployment procedures, patient conditions, and environment, and no angiograms or devices were submitted for investigational purposes.The ifu additionally lists precautions: in the event 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.The dhr documentation was reviewed and showed no indication that the manta closure device did not meet specifications.Risk documentation was reviewed, and tract deployment is a known risk.The following potential adverse events related to the deployment of vascular closure devices have been identified: other access site complications leading to bleeding, hematoma, pseudoaneurysm, or arterio-venous fistula, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.

Event Description

It was reported that: the patient overweight and the belly had to be taped up prior to the tavi procedure.Access was made on the right cfa but with a lot of difficulty as the track was more on a horizontal plane and the introducers had go to through lots of tissue.Nonetheless, they decided to use manta and the depth location was made without any issue at 6+1=7cm.After the tavi all the proper steps to deploy the manta 18f were performed properly right up to the advancement of the radio opaque marker.At this point there was still arterial bleeding.They decided to inflate a 9mmx40cm balloon at the puncture site through the contralateral access.After 5 minutes of inflation, there was still arterial bleed at deflation of the balloon.They elected to deploy an 10mmx59mm covered stent through the contralateral access.Bleeding immediately stopped at skin level and no extravasation was seen on the control angio.The operator does not blame the manta device, but a challenging case with a less than optimal access.Additional information: "the radiopaque marker on post procedural contralateral femoral angiogram seemed to be positioned far from the artery.As if, there was tissue caught between the marker and the artery, which would explain the closure failure.There was pulsatile blood flow from the site post manta deployment.The operator applied manual pressure to stop the bleeding while preparing the interventions from the contralateral side.Blood loss not significant to have a blood transfusion.All vital signs of the patient remained stable during the management of the site." the patient was reported as fine post procedure.

• 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: 16794463
• MDR Text Key: 313807374
• Report Number: 3010252479-2023-00082
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: 00856279007062
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P180025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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: MN2201490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• 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