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

Model Number	ESBF3214C103EE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2024
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 60 mm aaa.It was reported that a follow-up ct taken almost nine years later showed a ia endoleak.Intervention was performed a non-mdt was implanted and the sma and both renal arteries were fenestrated and stented.Per the physician the cause of the event was anatomy related due to disease progression.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
B5: additional information received: it was reported that bilateral type ib endoleaks were treated with non-medtronic stents at the same time when treating the type ia endoleak.Film evaluation summary: the reported type ia endoleak was confirmed on the ct¿s received; however, the exact cause of the type ia endoleak could not be dete rmined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Earlier post-implant films were not provided for comparison or for review of disease progression over time.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause, but these were not provided.From the films provided, it appeared that the main body bifurcate may have migrated which would have increased the likelihood of ia endoleak occurring.The right limb stent graft looks to have possibly migrated as well owing to its distance from the right internal artery, leading to the type ib endoleak.There is also a likely ib endoleak coming from the left limb.It is likely that disease progression and aneurysm morphology changes, over the 9 year period of implantation were factors in the loss of proximal and distal seal and concomitant possible stent graft migrations.Analysis of the returned ct¿s did not reveal any out of specification 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.

• Brand Name: ENDURANT IIS 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: 20145586
• Report Number: 9612164-2024-04078
• Device Sequence Number: 14505502
• Product Code: MIH
• UDI-Device Identifier: 00643169439962
• UDI-Public: 00643169439962
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 10/09/2024

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: 06/18/2017
• Device Model Number: ESBF3214C103EE
• Device Catalogue Number: ESBF3214C103EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2015
• 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: 70 YR
• Patient Sex: Male