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

Catalog Number	ESBF3614C103E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Confusion/ Disorientation (2553); Constipation (3274); Insufficient Information (4580); Kidney injury (4882)
Date of Event	07/04/2024
Type of Reportable Event	Death
Event or Problem Description
An endurant iis bifurcate stent grafts system and endoanchors were implanted in the endovascular treatment of a aaa as part of the hercules post market clinical study.Approximately 5 weeks post index procedure, the patient was admitted with lower abdominal pain and constipation.The patient was also noted to be experiencing delirium.The patient had a ct scan the following day which showed a non-enhancement of the lower and mid poles of the right kidney in keeping with an acute infarction.There was a perinephric inflammatory stranding which was said to be likely the cause of the patients symptoms.Abrupt filling defect in the distal hilar aspect of the more lateral branch of the right renal artery is consistent with arterial infarct.Minor infarct seen on the left upper pole of the left kidney.It is reported that approximately 5 months later the patient passed away.The cause of death is unknown.The death was assessed by the medical monitor to be possibly related to the stent graft , not related to the endoanchors, not related to the index procedure , not related to the stent graft deployment and possibly related to the aneurysm.The death was assessed by the site as not related to the stent graft, endoanchors, index procedure, stent graft deployment or aneurysm.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1620c124e, serial/lot#: (b)(6), ubd: 20-feb-2026, udi#: (b)(4), product id: etlw1616c124e, serial/lot#: (b)(6), ubd: 14-jun-2025, 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.
Additional Manufacturer Narrative
B5; additional information received : it was reported the patients wife had called to cancel appointments and then reported the patients death.There are no details available about the death and it is unknown whether it took place in a hospital or at home.The information regarding the lower abdominal pain, constipation , delirium and kidney infraction were reported in error and did not occur in this patient.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: 21730659
• Report Number: 9612164-2025-01613
• Device Sequence Number: 21083028
• Product Code: MIH
• UDI-Device Identifier: 00643169439955
• UDI-Public: 00643169439955
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2026
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: No
• 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: 03/11/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/02/2025
• Date Device Manufactured: 02/07/2024
• 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."
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 104 KG