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

Model Number	ETLW1620C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An aneurx stent graft system was implanted during the endovascular treatment of a 76mm abdominal aortic aneurysm.It was reported approximately 16 years post the index procedure, follow up ct identified a type ib endoleak.Per the physician the cause of the type ib endoleak was anatomy related due to disease progression in the right common iliac artery.No additional clinical sequalae were provided and the patient will be monitored.
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.
Additional Manufacturer Narrative
Additional information received: it was reported approximately 6 years post the index procedure that the patient underwent an intervention on to treat a type ia endoleak due to infrarenal neck dilatation where an endurant cuff was implanted proximally within the aneurrx main body.An endurant limb (etlw1620c124e, sn v04256542 ) was implanted to extend the length of the right aneurx limb.No endoleak at that setting.The physician just wanted more length.Film evaluation summary: the reported type ib endoleak was confirmed on the cts provided and was observed in the most distal device, the endurant ii stent graft limb etlw1620c124e.Although pre-implant cts and ct scans from earlier dates were not available for assessment of the patient's anatomy and to compare the stent graft configuration overtime, it is likely that disease progression over the 10 years since implantation was a contributory factor.No loss of seal/ endoleak noted in left limb stent graft.Analysis of the returned films did not reveal any stent graft integrity issues.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
B5; additional information received: it was reported that an intervention was performed to treat the type ib endoleak.The right hyp ogastric artery was embolized with five coils and an endurant limb was implanted within the existing limb covering the ostium of the right hypogastric artery and landed with the proximal right external iliac artery and the type 1b endoleak resolved.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 CA ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway CA ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20265358
• Report Number: 2953200-2024-00008
• Device Sequence Number: 8298740
• Product Code: MIH
• UDI-Device Identifier: 00613994991645
• UDI-Public: 00613994991645
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 11/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2016
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 11/05/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/05/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2014
• 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: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male