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

Model Number	ETLW1616C82E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	01/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: etlw1613c93e sn (b)(4), expiration date: 2018-10-27, udi # (b)(4).Film evaluation summary: the exact cause of the left limb occlusion could not be determined from the films provided.The pre-implant anatomy is unknown, and images during implant were not available for review.The blood flow dynamics could not be assessed from the ct¿s provided.Thrombus was seen within the bifurcate aortic body, and the contra limb + limb extension on the left side were 100% occluded beginning at the level of the flow divider, extending distally into the left femoral artery where blood flow reconstituted.The bifurcate ipsi limb and limb extension were patent, and no occlusion was seen distal to the right limbs.It is possible that the occlusion may have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.The occlusion may be anatomy related.Near the mid-level of the calcified lcia, the left limb extension was acutely angulated approximately 70° laterally and at this lateral bend the limb was slightly compressed down to a minimum of 10mm od (6mm flow lumen diameter).The calcified femoral arteries may have also contributed.
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for the endovascular treatment of an abdominal aortic aneurysm.Vessel morphology was reported as there was severe calcification in the femoral arteries.It was reported that the patient presented emergently with a cold left foot and leg pain while walking.The ct revealed that there was occlusion of the left internal, external iliac arteries, and bilateral anterior tibial arteries.The patient was hospitalized and given an iv with heparin.The physician elected to perform a right femoral to left femoral bypass.The blood flow was restored and no complications.Per the physician¿s dictation in the operative report the severe calcification was most likely the cause of the thrombosis resulting in the occlusion in the left limb.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: 6305823
• Report Number: 2953200-2017-00154
• Device Sequence Number: 18840683
• Product Code: MIH
• UDI-Device Identifier: 00643169467576
• UDI-Public: 00643169467576
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/13/2017

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: 11/10/2018
• Device Model Number: ETLW1616C82E
• Device Catalogue Number: ETLW1616C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 02/06/2017
• 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: 67 YR