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

Model Number	ETLW1616C156E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Failure to follow instructions both of the stent graft limbs were implanted in the ipsilateral side.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in the patient for the endovascular treatment of a 55m diameter abdominal aortic aneurysm.During the index procedure, it was reported that both of the stent graft limbs were implanted in the ipsilateral side.The procedure was then converted to an open repair and the stent grafts were explanted.As per the physician, the cause of the event was due to user error.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
• MDR Report Key: 7965213
• Report Number: 2953200-2018-01468
• Device Sequence Number: 13879697
• Product Code: MIH
• UDI-Device Identifier: 00643169467668
• UDI-Public: 00643169467668
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: 07/22/2020
• Device Model Number: ETLW1616C156E
• Device Catalogue Number: ETLW1616C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2018
• Initial Report FDA Received Date: 10/15/2018
• 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: 69 YR