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

Model Number	ESBF2514C103E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a system report.The section d information is for the primary device, which was in use with the following: brand name endurant ii iliac stent graft; product id etlw1613c156e (serial: (b)(6); product type: 0180-aortic stent graft; implant date (b)(6) 2025; explant date brand name endurant ii iliac stent graft; product id etlw1613c156e (serial: (b)(6); product type: 0180-aortic stent graft; implant date (b)(6) 2025; 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 as part of the advance study for the treatment of abdominal aortic aneurysm.Esbf2514c103e was successfully placed followed by etlw1613c156e in the right iliac artery, and etlw1613c156e in the left iliac artery.It was reported 1 day post index procedure, the patient had a post procedure creatinine level of 1.55 mg/dl.The acute kidney injury occurred due to the coiling of the patients¿ accessory renal arteries due to the patient¿s anatomy during the evar procedure prolonging the patients existing hospitalization.The patient received treatment and was hydrated with fluids and monitored overnight.It was reported the following day, that the patients creatinine level dropped and was 1.52 mg/dl.The patient was discharged on the same day with an order for follow-up labs to monitor creatinine levels.The sponsor assessed the as related to the index procedure and not related to the device.
Additional Manufacturer Narrative
Correction to annex f code: imf f08 missed in the previous report.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; the site assessed the acute kidney injury as not related to the study device, not related to the patient underlying condition/ disease and having a causal relationship to the index procedure.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information received: it was reported that the acute kidney injury had resolved 9 months after its onset.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: 21239195
• Report Number: 9612164-2025-00417
• Device Sequence Number: 18255495
• Product Code: MIH
• UDI-Device Identifier: 00643169439986
• UDI-Public: (01)00643169439986(17)260205(21)V31343930
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 12/03/2025

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: 02/05/2026
• Device Model Number: ESBF2514C103E
• Device Catalogue Number: ESBF2514C103E
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/04/2025; 02/12/2025; 12/02/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/05/2025; 02/14/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White