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

Model Number	ETLW1620C156E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film analysis summary: the reported contra limb migration out of the left common iliac artery and resulting distal type i endoleak was confirmed.The exact cause could not be determined from the limited films provided; pre-implant and earlier post-implant ct¿s were not available for review.It appears likely that disease progression due to iliac artery dilatation likely contributed to the limb migration, endoleak, and potential aaa sac expansion.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an unknown diameter abdominal aortic aneurysm.It was reported that approximately three years later the patient presented emergently.A type ib endoleak was noted, with migration of the left iliac limb from its initial deployment site at the lcia.The physician successfully treated the patient by implanting an endurant limb extension (size 1624156) on the same day.The physician stated the cause of the event was anatomy related.The iliac appeared to dilate and the limb pulled out of the iliac into the aaa.The cause of the dilation couldn't be determined.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 TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ca
• MDR Report Key: 8568217
• Report Number: 2953200-2019-00583
• Device Sequence Number: 1639136
• Product Code: MIH
• UDI-Device Identifier: 00613994991652
• UDI-Public: 00613994991652
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 03/24/2016
• Device Model Number: ETLW1620C156E
• Device Catalogue Number: ETLW1620C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR