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

Model Number	ETBF2813C145E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that the patient presented to the er with a cold leg.Ct performed revealed an occlusion of the patients right ipsilateral stent graft limb and reduced flow diameter in the contralateral left graft limb.Additionally, considerable thrombus build-up was noted in the aortic section of the bifurcated piece.On the same date, a thrombectomy was performed on the patient¿s contralateral limb to remove the clot and a stent was also placed in that area to improve flow on that side.A fem-fem bypass was performed to restore flow to the patients right lower extremity.It was noted that the patient has also been prescribed anti-coagulants to dissolve and retard clotting.The treatment performed resolved the issue.As per the physician, the cause of the event was due to hyper-coagulopathy and polycythemia of the patient.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Film review: the exact cause of the stent graft occlusion could not be determined from the limited films provided.Pre-implant anatomy was not provided, and images during implant were also not available.A single returned still angiogram from an unknown study date confirmed that the right/ipsi limb was 100% occluded beginning at the flow divider.In addition, there was substantial thrombus build-up along the inner wall of the bifurcate aortic body, as well as some thrombus seen within the contra limb especially near the distal end.Blood flow was observed only distal to the left limb.Analysis of the returned films did not reveal any stent graft characteristics that could explain the observed occlusion/thrombus.No obvious stent graft kinks or compression was observed with the devices.It is possible that this may have been caused by the reported patient condition; hyper-coagulopathy and polycythemia.Poor distal runoff may have also contributed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7132846
• Report Number: 2953200-2017-02002
• Device Sequence Number: 1310558
• Product Code: MIH
• UDI-Device Identifier: 00613994991294
• UDI-Public: 00613994991294
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 09/13/2018
• Device Model Number: ETBF2813C145E
• Device Catalogue Number: ETBF2813C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 12/03/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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: 60 YR