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	Pain (1994)
Date of Event	08/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a unknown sized ruptured abdominal aortic aneurysm.It was reported that the patient presented emergently just under seven years later, with complaints of abdominal pain.A cta was performed and it showed the limb etlw1620c156e that had been implanted in the left common iliac artery had pulled up into the aneurysm sac causing a ib endoleak.Intervention was performed on the same date, the left hypogastric artery was embolized with coils and a 16/16/124 endurant limb was implanted from the flow divider followed by another endurant limb 16/13/156 which was implanted to extend to the left external iliac artery.It was noted the left common iliac artery was measuring over 30mm.The grafts were ballooned and a final angiogram showed the endoleak had resolved.As per the physician the cause of the event is anatomy and disease progression.No additional clinical sequelae were provided 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 ; IE
• MDR Report Key: 10506841
• Report Number: 9612164-2020-03397
• Device Sequence Number: 3033051
• Product Code: MIH
• UDI-Device Identifier: 00613994991652
• UDI-Public: 00613994991652
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 06/25/2015
• Device Model Number: ETLW1620C156E
• Device Catalogue Number: ETLW1620C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2020
• Initial Report FDA Received Date: 09/09/2020
• 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: 70 YR