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

Model Number	ETLW1613C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Limb Pain (4836)
Date of Event	07/12/2024
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: product id: esbf2814c103e, serial/lot #: (b)(6), ubd: 22-jan-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.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 55mm abdominal aortic aneurysm.It was reported approx.3 months post index procedure, the patient experienced left leg pain.A ct scan revealed that the endurant stent graft limb (etlw1613c124e) was found to be occluded, although no abnormalities were found in the limb itself.1 day post follow up, intervention was performed.The physician initiated a cutdown on the left side and used percutaneous access on the right.A non mdt (14mm) balloon was placed up the right side, and a non mdt over- the-wire was used to remove the clot.After several passes, a reliant balloon was used to extract the remaining clot from the endurant limb.An angiogram was conducted, revealing a small amount of clot in the main body portion of the graft.To address this, an endurant cuff (etcf3232c49e) was placed in the main body to trap the clot, and a endurant stent graft limb (etlw1610c156e) was extended down the external iliac artery since the hypogastric artery was occluded.After ballooning the limb, a non mdt extension was added.The final angiogram revealed the left renal artery had a stenosis vs.Small piece of clot in the origin, it was confirmed that the endurant cuff did not cause the renal artery stenosis/clot.A non-mdt 7x19 stent was placed.The final angiogram showed no remaining clot and the patient is doing well.Per the physician the cause of the limb occlusion was anatomy related suspected to be due to stenosis in the proximal left external iliac artery, causing poor outflow, leading to the limb occlusion.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: 19828300
• Report Number: 9612164-2024-03405
• Device Sequence Number: 18289889
• Product Code: MIH
• UDI-Device Identifier: 00643169467590
• UDI-Public: 00643169467590
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: 100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/25/2024

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 Expiration Date: 08/30/2025
• Device Model Number: ETLW1613C124E
• Device Catalogue Number: ETLW1613C124E
• 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: 07/21/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: 62 YR
• Patient Sex: Male