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

Model Number	ESBF3614C103E
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 77 mm aneurysm experienced a pre-operative aneurysm rupture and was treated with a stent graft esbf3614c103e endur iis bif.Approximately 5 months post index procedure, a type ia endoleak and graft infolding were identified.The graft exhibited a crescent shape infolding towards the flow divider, and a small type 1 endoleak was noted.Intervention was performed approximately 3 months later, including intravascular ultrasound and ballooning with two reliant balloons; however, the infold and endoleak remained unresolved.A decision was made to use an aptus device to address the small type ia endoleak.The leak was not visible on angiograms, leaving its resolution uncertain.It was noted that the patient got very sick after the ct scan and was hospitalized and needed extra time to recover from his hospitalization.A repeat computed tomography scan was planned to further evaluate the stent graft and endoleak.Per the physician the cause of the type ia endoleak and infolding is undetermined.It was stated that no thrombus, calcification, tortuosity, or graft oversizing contributed to the event.No additional clinical sequelae were reported, 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
Film evaluation summary: the reported stent graft infolding and endoleak were confirmed on the films provided.The endoleak appears most likely to be a type ia proximal endoleak, likely related to the infolding.Although the cause of the infolding could not be conclusively determined, it is possible that a slight oversizing of the stent graft, by implanting a 36mm device in an aortic neck measuring 26mm to 28mm, may have contributed.The endurant ii/iis stent graft system instructions for use recommends that "the aortic sections of the bifurcated stent graft configurations should be oversized 10% to 20% in relation to the actual measured inner vessel diameter." analysis of the returned films 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.
Additional Manufacturer Narrative
Additional information received: it was reported that the patient does not want any additional procedures done.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: 21966524
• Report Number: 9612164-2025-02223
• Device Sequence Number: 8492507
• Product Code: MIH
• UDI-Device Identifier: 00643169439955
• UDI-Public: 00643169439955
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/10/2025

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: 12/19/2025
• Device Model Number: ESBF3614C103E
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 06/10/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/19/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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: 83 YR
• Patient Sex: Male