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

Model Number	ETEW1313C82E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact cause of the reported inaccurately delivery of the bifurcate leading to unintentional partial coverage of the left renal artery, and the reported stenosis in the right common iliac artery cannot be conclusively determined from the pre-implant films provided.Films at implant were not provided; the reported events cannot be confirmed.Pre-implant cta's showed the infrarenal aortic neck was angled ~ 65 deg a-p, and that the aortic neck to the aneurysm sac contained mild thrombus.It is possible that the angulated aortic neck may have contributed to the reported inaccurate delivery which resulted in the partial coverage of the left renal artery.Pre-implant films also showed that the vessel just distal to the right hypo bifurcation was highly angulated.This high angulation may have resulted in the flow constriction in the rcia, which resulted in the reported stenosis.The pre-implant thrombus may have also contributed.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a greater than 5.0cm abdominal aortic aneurysm.Mild proximal neck calcification and mild bilateral iliac calcification was noted.It was reported that the stent graft was deployed and there was great filling of the left renal artery; however, the angiogram appeared to show that the fabric of the graft was partially covering the left renal artery.Another manufacturer¿s stent was placed in the left renal.It was also noted that there was narrowing of the right common iliac artery; so the physician placed another manufactures stent there as well.It was reported that the event was resolved.The physician stated that the cause of the event could not be determined.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: 6251173
• Report Number: 2953200-2017-00050
• Device Sequence Number: 914301
• Product Code: MIH
• UDI-Device Identifier: 00613994991386
• UDI-Public: 00613994991386
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/20/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: ETEW1313C82E
• Device Catalogue Number: ETEW1313C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: 12/20/2016
• Initial Report FDA Received Date: 01/13/2017
• 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: 66 YR