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

Model Number	ENLW1613C124E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 5 cm diameter abdominal aortic aneurysm.It was reported that the ct revealed a distal type i endoleak from the endurant ipsilateral limb of the bifurcated stent graft.The aneurysm is currently 4.8 cm in diameter.The patient¿s iliac artery has dilated to 24mm-18.5 mm in diameter.The physician elected to implant an endurant iliac limb extension to the origin of the internal artery.The distal type i endoleak was resolved.There is a type iv endoleak present in the ipsilateral extension however the physician stated that this was due to a large dose of anti-coagulate medication given and short procedure time.It was also noted that the endurant contralateral limb was occluded.It is unknown when the occlusion occurred, since there is blood flow there has not been and will not be treatment for the occlusion.Per the physician, the cause of the distal type i endoleak was due to user error.The ipsilateral limb should have been extended distally at the index procedure.The cause of the occlusion is related to the patient¿s anatomy.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 6612909
• Report Number: 2953200-2017-00925
• Device Sequence Number: 13456380
• Product Code: MIH
• UDI-Device Identifier: 00613994761972
• UDI-Public: 00613994761972
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: ENLW1613C124E
• Device Catalogue Number: ENLW1613C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR