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

Model Number 2115

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pseudoaneurysm (2605)

Event Date 02/28/2023

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: pt developed a pseudo aneurysm that night.Needed a blood transfusion and went to surgery.Pt recovered and was discharged home.This is from a phone call from the tavr coordinator.Additional information on 10mar2023: during a tavr procedure on (b)(6) 2023 micropunture and ultrasound were utilized to gain access in the right common femoral artery.Vessel size was 7.2mm with no reported calcification or tortuosity.Measured depth for the manta was 5+1=6 and there were no issues advancing or withdrawing procedural sheaths.Blood pressure was 158/65mmhg and act was 360 prior to closure.50mg of protamine and an unknown dose of heparin were administered intravenously during the procedure.The account stated that the patient was taken to surgery later that night for bleeding and had a blood transfusion.The account stated that the patient had a pseudoaneurysm.The account also noted that the physician had stuck through the inguinal ligament during access which led to the complication.Also , the account stated that they would not provide any more information regarding the case.The patient was reported as fine post the procedure and was discharged home.

Manufacturer Narrative

(b)(4).The device was not returned for investigation.No return product evaluation could be completed.Ct images were obtained by vsi however, were inconclusive and did not provide any information relevant to the analysis.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 tavr procedure, an 18f manta was deployed for closure in the right common femoral artery.Access was achieved utilizing micropuncture and ultrasound.Access position was unable to be determined due to no angiograms being taken during the procedure.Although, during access, the physician had stuck through the inguinal ligament.Arteriotomy was 7.2mm, with no calcification or tortuosity, with a measured depth of 5mm + 1mm.No issues were encountered advancing or withdrawing the procedural sheaths.Prior to closure, activated clotting time (act) was 360, and heparin and protamine were administered.The manta device was deployed to the measured depth, and hemostasis was achieved after five minutes of manual pressure.Later that evening, the patient was bleeding, developed a pseudo aneurysm, was transferred to surgery, and received an unknown amount of packed red blood cells.A pseudo-aneurysm can go undetected and not cause any complications and can occur because of surgery or trauma; the formation of a pseudoaneurysm does not signify a device failure.The suspected root cause of the pseudo aneurysm may likely be due to user error in utilizing manta in a patient with high access (at or above the inguinal ligament).Due to the location of the manta deployment, it is likely the implant was unable to effectively maintain a seal and the implant became dislodged.The patient recovered and was later discharged home.The ifu warns do not to use if the puncture site is proximal to the inguinal ligament or above the most inferior border of the epigastric artery (iea), as this may result in retroperitoneal bleeding.The following potential adverse events related to the deployment of vascular closure devices include retroperitoneal bleeding, and its consequences, as a result of failed closure in the setting of access above the inguinal ligament or the most inferior border of the epigastric artery (iea).Additionally, procedure requirements listed in the ifu indicate a pre-procedure cta is recommended to assess femoral artery anatomy.

Event Description

It was reported that: pt developed a pseudo aneurysm that night.Needed a blood transfusion and went to surgery.Pt recovered and was discharged home.This is from a phone call from the tavr coordinator.Additional information on 10mar2023: during a tavr procedure on (b)(6) 2023 micropunture and ultrasound were utilized to gain access in the right common femoral artery.Vessel size was 7.2mm with no reported calcification or tortuosity.Measured depth for the manta was 5+1=6 and there were no issues advancing or withdrawing procedural sheaths.Blood pressure was 158/65mmhg and act was 360 prior to closure.50mg of protamine and an unknown dose of heparin were administered intravenously during the procedure.The account stated that the patient was taken to surgery later that night for bleeding and had a blood transfusion.The account stated that the patient had a pseudoaneurysm.The account also noted that the physician had stuck through the inguinal ligament during access which led to the complication.Also , the account stated that they would not provide any more information regarding the case.The patient was reported as fine post the procedure and was discharged home.

• 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: 16536567
• MDR Text Key: 311217456
• Report Number: 3010252479-2023-00052
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: 2115
• Device Catalogue Number: 2115
• Device Lot Number: MN2201468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2023
• 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: 70 YR
• Patient Sex: Female