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

Model Number	ETLW1613C93E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft was implanted during the endovascular treatment of a 50mm abdominal aortic aneurysm on (b)(6) 2024.The aortic neck was wide, short and conical.Bilateral dissections in common iliacs were noted with a pau proximal to the right hypogastric.  it was reported during the index procedure, etlw1616c93e was measured but due to angulation and tortuosity the limb landed short of markers.An additional limb was placed and the procedure completed successfully.Per the physician the cause was anatomy related due to tortuosity.  no additional clinical sequelae were provided, and the patient is fine.
Additional Manufacturer Narrative
B5;additional information received: it was confirmed that both endurant limbs landed short.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
Section d references the main component of the system.Other medical products in use during the event include: brand name endurant ii iliac stent graft; product id etlw1616c93e (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2024; explant date 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.
Additional Manufacturer Narrative
Film evaluation summary: the reported inaccurate delivery of the endurant limb stent grafts could not be assessed from the single pre-implant image provided, therefore, the cause of the event could not be conclusively determined.Lack of pre-implant cts prevented a thorough assessment of the pre-implant anatomy and procedural angiograms showing deployment of the limbs were not available for assessment of the reported event.It is possible that anatomical factors, such as the observed common iliac tortuosity may have contributed to the reported inaccurate delivery , but this could not be confirmed.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 ILIAC 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: 19380497
• Report Number: 9612164-2024-02487
• Device Sequence Number: 15375785
• Product Code: MIH
• UDI-Device Identifier: 00643169467682
• UDI-Public: 00643169467682
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• 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,Followup,Followup
• Report Date (Section B): 06/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2025
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 05/27/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 05/23/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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: 78 YR
• Patient Sex: Male