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

Model Number	ETLW1620C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Insufficient Information (4580)
Date of Event	02/13/2024
Type of Reportable Event	Death
Event or Problem Description
An endurant iis stent graft system was implanted in the endovascular treatment of an abdominal aortic aneurysm.It was reported approximately 4 years post the index procedure, the patient presented emergently with a ruptured abdominal aortic aneurysm.Imaging showed a suspected type iiib endoleak originating from the previously placed bifurcate graft.Intervention was performed where an endurant aui and endurant extension cuff were implanted which resolved the endoleak.No endoleak was visualized on angiogram after placement of the aui graft.It was reported the patient expired on an unknown date following the aortic rupture.As per the physician the cause of the type iii endoleak could not be determined.It is believed the endoleak caused the aneurysm rupture.
Additional Manufacturer Narrative
Continuation of d10: other relevant device(s) are: product id: e tlw1620c124e, serial/lot #: (b)(6), ubd: 15-jan-2022, udi#: (b)(4).Product id: etew2020c82e, serial/lot #: (b)(6), ubd: 18-sep-2021, udi#: (b)(4).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.
Additional Manufacturer Narrative
Additional information received: no other invasive procedure was performed following the index procedure.The patient expired 3 days after presenting emergently.The cause of death was the aneurysm rupture.It was confirmed a non mdt cuff and a non-medtronic limb were implanted during the intervention with the etuf3614c102e graft.Film analysis summary: the reported endoleak leading to the aaa rupture was confirmed; however, the exact type and cause could not be fully determined from the films provided.The reported patient death could not be assessed.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.From review of the films received, the endoleak was likely a type iiib fabric endoleak, possibly caused by fabric abrasion.Fabric wear due to external abrasion from aortic calcification or from adjacent stent(s) abrading the bifurcate are a potential root cause(s).The stent graft angulation and the potential aneurysm morphology changes during the implant duration, may have also exacerbated the fabric abrasion wear.Type ii endoleaks from collateral vessels surrounding the aneurysm sac also could not be ruled out.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 or Problem Description
An endurant iis stent graft system was implanted in the endovascular treatment of an abdominal aortic aneurysm on the (b)(6) 2020.  it was reported on 13-feb-2024, the patient presented emergently with a ruptured abdominal aortic aneurysm.Imaging showed a suspected type iiib endoleak originating from the previously placed bifurcate graft.Intervention was performed where an endurant aui and endurant extension cuff were implanted which resolved the endoleak.No endoleak was visualized on angiogram after placement of the aui graft.It was reported the patient expired on an unknown date following the aortic rupture.As per the physician the cause of the type iii endoleak could not be determined.It is believed the endoleak caused the aneurysm rupture.*additional information received 15th of april 2024 and 25th of april 2024: no other invasive procedure was performed following the index procedure.The patient expired on the (b)(6) 2024 (3 days after presenting emergently).The cause of death was the aneurysm rupture.It was confirmed a non mdt (gore) cuff and a non-medtronic ( gore) limb were implanted during the intervention with the etuf3614c102e graft.
Additional 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.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 18995480
• Report Number: 9612164-2024-01497
• Device Sequence Number: 11535475
• Product Code: MIH
• UDI-Device Identifier: 00643169467552
• UDI-Public: 00643169467552
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 05/10/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/07/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Death
• Patient Age: 85 YR
• Patient Sex: Male