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

Catalog Number	ETLW1620C146E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: this is a system report.The section d information is for the primary device, which was in use with the following: product id: etlw1620c156e, serial/lot #: (b)(6), ubd: 05-nov-2027, 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.
Event or Problem Description
An endurant iis stent graft system was implanted during the endovascular treatment of a 90mm abdominal aortic aneurysm.It was reported approximately 3 years post the index procedure, follow up ct identified a type ib endoleak in etlw1620c146e ((b)(6)).Intervention was completed.An initial angiogram confirmed a type ib endoleak.A catheter was placed behind the graft into the abdominal aortic aneurysm sac and the sac was embolized using non mdt (penumbra coils) and glue.A right graft limb extension etlw1620c156e ((b)(6) was then implanted.An injection through the sheath again showed a type ib endoleak.After discussion, the right hypogastric artery was embolized and the right graft limb was extended and relined into the proximal right external iliac artery with etlw1613c156e & etlw1616c146e and the endoleak was confirmed as resolved.Per the physician the cause was due to anatomy, specifically dilatation of the right common iliac artery.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II ILIAC 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: 25315803
• Report Number: 9612164-2026-02773
• Device Sequence Number: 18626605
• Product Code: MIH
• UDI-Device Identifier: 00763000519964
• UDI-Public: (01)00763000519964(17)241109
• 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: 2023
• 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): 05/28/2026

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: 11/09/2024
• Device Catalogue Number: ETLW1620C146E
• 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: 05/27/2026
• Initial Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 11/10/2022
• 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: Required Intervention
• Patient Sex: Female