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

Model Number	ETLW1613C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2024
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 aui stent graft system was implanted during the endovascular treatment of a 60mm aaa.An endurant cuff etcf2828c49e was implanted 10 years and five months later due to a type ia endoleak which was identified on an unknown date.It was reported that the patient presented emergently the following month and a ib endoleak was observed in the left iliac limb etlw1613c93e.Intervention was performed on the same day and a limb extension was implanted.This resolved the ib endoleak.Per the physician the cause of the ib endoeak was anatomy related due to iliac disease progression.No cause of the ia endoleak was provided.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Additional information received: an endurant limb etlw1616c93e was implanted on the day the patient presented to treat the ib endoleak in etlw1613c93e.The iliac had dilated due to disease progression deterioration the that caused the ib endoleak it was reported that the patient presented 7 weeks post the intervnetion with a ib endoleak in the left iliac.A etew1010c82e/ (b)(6) was implanted as treatment on the same 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.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: 20331549
• Report Number: 9612164-2024-04414
• Device Sequence Number: 7878322
• Product Code: MIH
• UDI-Device Identifier: 00613994991539
• UDI-Public: 00613994991539
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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
• Report Date (Section B): 11/22/2024

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: 09/13/2015
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• 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: 09/08/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/22/2024
• Date Device Manufactured: 09/13/2013
• 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: 89 YR
• Patient Sex: Male