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

Model Number	ETUF2314C102E
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	10/28/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 during the index procedure to treat a 51 mm abdominal aortic aneurysm, the patient presented with narrow access and diffused calcification in the common iliac arteries, as well as significant circumferential calcification and vessel narrowing in the distal aorta.Balloon angioplasty with 8 mm diameters was performed to break up calcification and dilate the right common iliac.The stent graft etuf2314c102e endur ii aui was inserted on a stiff wire "bareback" but could not pass the additional narrowing in the distal aorta.The device was removed and subsequently delivered through an 18 french sheath, which was later determined to have most likely caused perforations in multiple places in the common iliac and/or proximal external iliac artery.At that moment, a blood pressure drop indicated vessel perforation , and the 18fr sheath was advanced into the distal aorta to occlude the perforation.The endurant ii aui stent graft was successfully deployed in the aorta through the sheath.A non mdt stent was deployed from the distal end of the aui into the right common iliac to cover the perforation that looked localized to the proximal common iliac artery.Once the non mdt stent was deployed the sheath was pulled back to allow full ballooning of the non mdt stent.The patients blood pressure then dropped again and the process of extending non mdt stents into the right common iliac and right external iliac was repeated four times, with contrast injections used to assess containment of the perforations, which were not contained.The patient experienced blood loss into the abdomen and subsequently coded due to cardiac arrest from uncontrolled blood loss.Resuscitation efforts in the operating room were unsuccessful, and the patient died.The physician reported the cause of the event was that the utilization of a upsized 18fr sheath for delivering the 23aui was asking too much of the vessel, and that there may have been too much confidence in the vessel after performing the angioplasty.
Additional Manufacturer Narrative
Film evaluation summary: the reported events could not be confirmed on the pre-implant images provided; therefore, the cause of the events could not be conclusively determined.Procedural angiograms showing the insertion and deployment of the endurant ii aui stent graft would have allowed for a thorough analysis of the event, but these were not provided for review.The patients iliac arteries were noted as severely calcified and a narrowing in the distal aorta was reported which would have likely contributed to the reported difficulty positioning the delivery system.B5; additional information received: it was confirmed that the 18fr sheath used during the procedure was a non-medtronic device.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
Update to h6; coding.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 AUI 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: 23434977
• Report Number: 9612164-2025-05348
• Device Sequence Number: 20023251
• Product Code: MIH
• UDI-Device Identifier: 00643169232556
• UDI-Public: (01)00643169232556(17)270106
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: ETUF2314C102E
• Device Catalogue Number: ETUF2314C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 02/12/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/04/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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; Death
• Patient Age: 85 YR
• Patient Sex: Female