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

Model Number	ESBF2814C103E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
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.It was reported on the same date, ct imaging confirmed the presence of a unknown type endoleak.The sponsor assessed the unknown endoleak as being possible related to the index procedure and device.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: etlw1620c146e, serial/lot #: (b)(6), ubd: 27-jun-2026, udi#: (b)(4) ; product id: etlw1620c146e, serial/lot #: (b)(6), ubd: 19-aug-2026, 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
Additional information received: the endoleak identified on completion angiography at the end of the index procedure was confirmed as type ii endoleak with an undetermined subtype.No patient complications have been reported as a result of this event.Additional information received shows that there is no information to reasonably suggest that the devices in this report may have caused or contributed to a death or serious injury or that the devices in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.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: 21332500
• Report Number: 9612164-2025-00669
• Device Sequence Number: 18099612
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: 00643169439979
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 02/28/2025

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 Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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...."
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White