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

Model Number	ETLW1620C156E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for the endovascular treatment of a 100 mm in diameter abdominal aortic aneurysm.It was reported that, twenty days post index procedure, the patient presented emergently with occlusion in the left iliac endurant ii stent graft limb.Additionally, the endurant ii stent graft limb appeared to be kinked.The physician elected to give the patient thrombolytic medication overnight and, the following day, implanted another manufacturer¿s 14 mm bare self-expanding stent in the endurant ii stent graft limb.An angiogram then revealed that the endurant ii stent graft limb was completely patent with brisk flow and the event was resolved.Per the physician's statement the cause of the event was due to the angle in which the iliac entered the aorta, causing the kink.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 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: 6244516
• Report Number: 2953200-2017-00043
• Device Sequence Number: 464854
• Product Code: MIH
• UDI-Device Identifier: 00643169467545
• UDI-Public: 00643169467545
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2016

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: 11/10/2017
• Device Model Number: ETLW1620C156E
• Device Catalogue Number: ETLW1620C156E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 01/11/2017
• 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: 80 YR