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

Model Number	ETBF2513C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
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
It was reported that a evar procedure was performed to treat a 60mm aaa.During follow-up a type iii endoleak was noted in the endurant ii bifurcate.Per the physician the cause of the endoleak is anatomy and a possible device issue at the flow divider.
Additional Manufacturer Narrative
B5; additional information received:the endoleak was confirmed to be a type iiib endoleak at the flow divider of the main body.Per the physician, the cause of the event was neck degeneration with device failure.No intervention has been performed at this time as the patient is seeking a second opinion on the treatment at another facility.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
Product analysis conclusion: the reported endoleak was confirmed on the provided imaging; however, the cause of the event could not be conclusively determined.Lack of pre-implant ct scans did not allow for assessment of the pre-implant anatomy and earlier post-implant cts were not available for comparison.Angiograms, including endoleak interrogation, could have facilitated a more comprehensive determination of the endoleak source and cause.Type ia and ib endoleaks seem unlikely, given the adequate proximal and distal seals appeared adequate.A type iiia junctional endoleak also appears less likely due to sufficient component overlap.The endoleak appears most likely to be a type iiib fabric endoleak.Fabric wear due to external abrasion from adjacent calcification abrading the main body stent graft is a potential root cause.Potential changes in aneurysm morphology during implant duration may have exacerbated the fabric abrasion wear.A concomitant type ii endoleak may also be present, given the presence of patent lumbar arteries.B5; additional information received : it was confirmed intervention was performed at another facility where two etew2020c82e limbs were implanted to treat the iiib endoleak.It was confirmed the type iii endoleak resolved with the intervention.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: 21571356
• Report Number: 9612164-2025-01261
• Device Sequence Number: 21020724
• Product Code: MIH
• UDI-Device Identifier: 00613994991232
• UDI-Public: 00613994991232
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/23/2025

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: 08/19/2015
• Device Model Number: ETBF2513C145E
• Device Catalogue Number: ETBF2513C145E
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 03/19/2025; 04/10/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/08/2025; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2013
• 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: 87 YR
• Patient Sex: Female