MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number ETBF2820C166E

Device Problem Leak/Splash (1354)

Patient Problem Abdominal Pain (1685)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

An endurant ii stent graft system was implanted during the endovascular treatment of a 65mm abdominal aortic aneurysm.It was reported approximately 6 years post the index procedure, the patient presented with abdominal pain.Ct demonstrated an endoleak and contained haziness around the aaa.The patient was brought to or where diagnostic angiogram determined it was a type iiib fabric tear in the distal mainbody of the endograft possibly near the bifurcation of the graft.A 28 aui device was placed with a 16mm endurant limb in addition to a fem- fem bypass to successfully cover the tear.The cause of the tear is undetermined.No additional clinical sequalae was reported and the patient is fine.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18969426
• MDR Text Key: 338498875
• Report Number: 9612164-2024-01433
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00613994990969
• UDI-Public: 00613994990969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: ETBF2820C166E
• Device Catalogue Number: ETBF2820C166E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/25/2024
• Date Device Manufactured: 02/01/2018
• 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: 77 YR
• Patient Sex: Male