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

Model Number	ETLW1616C93E
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Defective Component (2292)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
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
An endurant ii stent graft system was implanted during the treatment of a 62mm abdominal aortic aneurysm.It was reported during the index procedure, the endurant ii contralateral limb was counted as 9 to the hypogastric artery.Endurant limb (etlw1616c93) was placed however, the limb foreshortened by 2 centimetres.Due to the foreshortening, there was an insufficient amount limb into the common iliac artery.To address this issue, it was recommended to add an etlw1616c82e graft limb.The healthcare professional identified the foreshortening of the limb as the cause of the event.It was recommended to add the etlw1616c82e to address the issue.The reported event has not been resolved, and the device remains implanted.
Additional Manufacturer Narrative
H.6 device code corrected 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
Additional info; the proximal aortic neck had a diameter of 20mm and a length of 25mm.Intraoperatively, a pigtail and the non mdt guidewire was placed on the left side, a retrograde performed, and counted 10.The etlw1616c93e foreshortened more than expected by 2 cm instead of the anticipated 1 cm, but implanting the etlw1616c82e resolved the issue.It was stated that a 124 device would have been a better selection.It is believed that the foreshortening may have been a combination of patient's anatomy and length of device being shorter than stated in the packaging.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
Film evaluation summary: the reported "sizing incorrect for patient" and "dimensional deviation" could not be confirmed on the films provided, therefore the cause of these events could not be determined.The availability of angiograms taken during the index procedure could have allowed for a thorough analysis of the measurements performed when the delivery system of enlw1616c95ee was introduced into the patient, but there were not provided for review.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.

• 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: 21078943
• Report Number: 9612164-2025-00085
• Device Sequence Number: 17867234
• Product Code: MIH
• UDI-Device Identifier: 00643169467569
• UDI-Public: 00643169467569
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 03/13/2025

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: 07/09/2026
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 02/05/2025; 02/05/2025; 03/04/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/03/2025; 03/04/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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: 61 YR
• Patient Sex: Male