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

Model Number	ESBF2514C103E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant ii stent graft system was implanted in a patient during the endovascular treatment of an abdominal aortic aneurysm.It was reported approximately 11 years post the index procedure, follow up ct identified a type ia and possible bilateral type ib endoleaks.The physician elected to transfer the patient to a different facility for possible further intervention.The cause of the endoleaks are undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Continuation of d10: this is a system report.The section d information is for the primary device, which was in use with the following:: etlw1616c124e, serial/lot #: (b)(6), ubd: 09-dec-2016, udi#: (b)(4) ; product id: etlw1613c124e, serial/lot #:(b)(6), ubd: 09-jun-2016, udi#: (b)(4).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 system was implanted in a patient during the endovascular treatment of an abdominal aortic aneurysm.It was reported approximately 11 years post the index procedure, follow up ct identified a type ia and possible bilateral type ib endoleaks.The physician elected to transfer the patient to a different facility for possible further intervention.The cause of the endoleaks are undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Correction to b5: device updated to correct name enduarant iis 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 TR
• 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: 25216629
• Report Number: 9612164-2026-02600
• Device Sequence Number: 10001665
• Product Code: MIH
• UDI-Device Identifier: 00643169439986
• UDI-Public: (01)00643169439986(17)161013
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2016
• Device Model Number: ESBF2514C103E
• Device Catalogue Number: ESBF2514C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 05/26/2026; 06/04/2026; 06/19/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 05/27/2026; 06/16/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".
• Patient Sex: Female