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

Model Number	ETLW1610C199E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the stent graft occlusion could not be determined from the films provided.The anatomy at implant is unknown, and films at implant and earlier follow-up¿s were not available for review; the blood flow dynamics could not be assessed from the ct¿s provided.Films from 8 months post-implant confirmed that the bifurcate aortic body contained significant thrombus, and the ipsi limb and ipsi/left limb extension were 100 % occluded.The blood flow down the left side reconstituted distal to left limb at the left internal/external bifurcation.It is possible that this occlusion was anatomy related; implanting within a narrow and calcified aorta.One (1) cm above the level of the gate the aorta narrowed down to 22mm in diameter.In this narrowed and calcified section of the aorta the left/ipsi limb was seen compressed down to 5mm id.Distal to the gate within the distal sac the left limb opened up to 11mm.No other stent graft compression or kinks were observed.The occlusion may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.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 iis stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the patient presented with claudication in their left leg.A ct revealed that the left limb had completely thrombosed and that the thrombus had propagated up into the main body from the flow divider up to the top of the graft.The physician also stated that the left limb appeared compressed at the level of the flow divider.Additionally, the physician thought that there appeared to be a narrowing in the right proximal external iliac artery just below the right limb.The physician thought that the narrowing of the artery may be impeding flow and contributing to the buildup of thrombus in the main body.No clinical sequelae were reported and the patient is being monitored by their physician.
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: 6362541
• Report Number: 2953200-2017-00284
• Device Sequence Number: 10771930
• Product Code: MIH
• UDI-Device Identifier: 00643169467620
• UDI-Public: 00643169467620
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2017

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: 10/22/2017
• Device Model Number: ETLW1610C199E
• Device Catalogue Number: ETLW1610C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2017
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR