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

Model Number	ETUF2514C102E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii aorto-uni-iliac stent graft was implanted for the treatment of a 50 mm diameter abdominal aortic aneurysm.It was reported that during the index procedure an angiogram revealed that the endurant ii aorto-uni-iliac stent graft was delivered approximately 8 mm distal to the desired location.No endoleaks were observed.The physician elected to implant a proximal 25x25x49 endurant cuff and a final angiogram revealed no endoleaks.The event was resolved.Per the physician the cause of the event was related to user error.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6222586
• Report Number: 2953200-2017-00015
• Device Sequence Number: 675133
• Product Code: MIH
• UDI-Device Identifier: 00643169232570
• UDI-Public: 00643169232570
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2016

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: 03/29/2017
• Device Model Number: ETUF2514C102E
• Device Catalogue Number: ETUF2514C102E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: 12/21/2016
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 73 YR