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

Catalog Number	ETBF3616C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/31/2024
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 etlw1620c124e (serial: (b)(6); product type: 0180-aortic stent graft; implant date (b)(6) 2013; brand name endurant ii iliac stent graft; product id etlw1616c124e (serial: (b)(6); product type: 0180-aortic stent graft; implant date (b)(6) 2013; 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
It was reported that a patient was treated for a 55mm abdominal aortic aneurysm with an endurant ii stent graft system.Approx.11 years, 4 months, post index procedure, a follow up ct imaging revealed a proximal type ia endoleak and a distal type ib endoleak, attributed to aneurysmal degeneration.Intervention was performed on the following day where a valiant captivia vamf3838c100tu stent graft was deployed at the level of the celiac artery.Laser fenestration was carried out in both renal arteries and the superior mesenteric artery , followed by placement of an endurant limb etlw1620c146 on the left and an etlw1624c146e on the right limb, extending both to the hypogastric arteries.The patient was reported to have done well and was discharged the following day.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
B5; additional information received; it was confirmed that the type ib endoleak was initially observed in both endurant limbs.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 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: 21411882
• Report Number: 9612164-2025-00901
• Device Sequence Number: 12892654
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 02/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2015
• Device Catalogue Number: ETBF3616C145E
• 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: 02/16/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2013
• 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: 84 YR
• Patient Sex: Male