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

Model Number	ETBF3220C166E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted during the endovascular treatment of an 80mm abdominal aortic aneurysm additionally, an endurant limb (etlw1624c93e) was implanted approx.8 years post index procedure and another limb (etlw1613c146e) was implanted approx.10 years post index procedure.According to the physician, these were likely used to address disease progression due to aneurysm expansion involving the iliac arteries.It was reported during a follow up visit approx.12 years, 5 months post index procedure, ct imaging confirmed the presence of a type ii endoleak.The patient received coil treatment, which successfully resolved the type ii endoleak the event was attributed to the patient's anatomy and disease progression.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: etlw1624c124e, serial/lot #: (b)(6), udi#: (b)(4); product id: etew2424c82e, serial/lot #: (b)(6), ubd: 25-sep-2014, udi#: (b)(4); product id: etew2424c82e, serial/lot #: (b)(6), ubd: 25-sep-2014, 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.

• Brand Name: ENDURANT II 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: 22344487
• Report Number: 9612164-2025-03199
• Device Sequence Number: 20975658
• Product Code: MIH
• UDI-Device Identifier: 00613994991027
• UDI-Public: 00613994991027
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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 Model Number: ETBF3220C166E
• Device Catalogue Number: ETBF3220C166E
• 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: 06/12/2025
• Initial Report FDA Received Date: 06/27/2025
• 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: 69 YR
• Patient Sex: Male