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

Model Number	ETBF3616C166E
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Rupture (2208); Aneurysm expansion (4597)
Date of Event	06/08/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
An endurant iis stent graft was implanted during the endovascular treatment of a abdominal aortic aneurysm.It was reported that approximately 11 years and 3 months post-index procedure the patient presented with a 110mm abdominal aneurysm rupture, and imaging revealed that the previously implanted endograft had migrated downward near the renal arteries, with at least two peaks of the suprarenal fixation still in place.There was a suspected fracturing of the suprarenal fixation.Parts of the supra renal stent were found at near renal arteries, while other parts of the supra renal stent were observed at the fabric portion that migrated down.A type ia endoleak was also confirmed by the physician.The patient was in stable condition but remained hospitalized and was recovering from the rupture.Intervention treatment included the implantation of a thoracic graft from the superior mesenteric artery to the previous graft.The previously implanted endurant limbs did not have any issues.Per the physician, the migration/separation of the endograft contributed to the type ia endoleak leading to the aneurysm rupture.No additional sequelae were provided and the patient will be monitored.
Additional Manufacturer Narrative
B5: additional information received: it was reported that a cta 10 years post the index procedure showed an increase in aneurysm size to 9.9cm with no evidence of endoleak at that time.The patient also had cta's one year and three years previous to that cta.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
Film analysis conclusion: the reported suprarenal stent fracture, stent migration, and type ia endoleak were confirmed based on the films provided.Lack of pre-implant ct scans did not allow for assessment of the pre-implant anatomy, and earlier post-implant ct scans were not available for comparison of the stent graft configuration over time.While the exact cause of the reported events could not be conclusively determined, it is possible that disease progression, along with changes in aneurysm morphology over the 11 years since implantation, may have contributed to the suprarenal stent fracture and migration which may have led to the type ia endoleak and the reported aneurysm rupture.The aneurysm rupture could not be confirmed based on the angiograms provided.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
Film evaluation summary: a single fracture at the lower apex of the suprarenal stent was observed on the reviewed ct scans taken approximately 10 years post-index procedure.There were no findings suggestive of a type ia endoleak.At least one lumbar artery was patent and appeared to communicate with the aneurysm sac.While no obvious endoleak was detected due to imaging artifacts, retrograde flow slowly filling the aneurysm sac is a possibility.Correction to b5; the excerpt previously provided "an endurant iis stent graft was implanted" should read " an endurant ii stent graft was implanted ".Correction to h6: additional annex e code 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 BIFURCATED 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: 22326010
• Report Number: 9612164-2025-03134
• Device Sequence Number: 8794172
• Product Code: MIH
• UDI-Device Identifier: 00613994991041
• UDI-Public: (01)00613994991041(17)151220(21)V04179771
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup
• Report Date (Section B): 09/05/2025

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: 12/20/2015
• Device Model Number: ETBF3616C166E
• Device Catalogue Number: ETBF3616C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 07/28/2025; 09/02/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 06/30/2025; 08/12/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2013
• 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: 77 YR
• Patient Sex: Male