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

Model Number	ETEW2828C82E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/23/2018
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
A talent stent graft system was implanted in a patient for the treatment of an 6.5cm abdominal aortic aneurysm.It was reported that a type ii endoleak was identified in the talent stent graft system on ct performed approximately 4 years post the index procedure.An endurant ii illac extension was implanted to treat the endoleak.The target location for the endurant ii iliac extension was the iliac bifurcation.It was reported that upon full deployment of the graft that the graft was deployed above the renal arteries.The physician performed an angiogram which showed patent flow to the celiac axis, sms and renal arteries.The physician decided to implant two more stents distal to the stent graft that deployed above the renals to occlude the endoleak and the event is reported as being resolved.The physician reported the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the reported endoleak and inaccurate delivery of the endurant during intervention could not be determined from the limited films provided.The anatomy at implant is unknown and earlier post-implant films were not provided.In addition, complete ct¿s showing the recently reported endoleak and current patient anatomy, and films during the intervention were not also not available for review.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 7537208
• Report Number: 2953200-2018-00754
• Device Sequence Number: 1818001
• Product Code: MIH
• UDI-Device Identifier: 00613994991416
• UDI-Public: 00613994991416
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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: 01/15/2020
• Device Model Number: ETEW2828C82E
• Device Catalogue Number: ETEW2828C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/22/2018
• 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: 83 YR