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

Model Number	ETBF3216C145E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an abdominal aortic aneurysm.The proximal neck diameters were 25.9 mm at 15 mm above the right renal, 26.1 mm at the right renal, 28.3 mm at 15 mm below the right renal, and 30.1 mm at 30 mm below the right renal.The rcia and lcia had 40 degrees lao and 35 degrees rao respectively.It was reported that a ct exam performed approximately 2 months post index procedure, revealed stent graft occlusion.An angiogram completed 2 days later revealed that there were no kinks in the stent graft; however, the stent graft was occluded up to the bifurcation of the endurant stent grafts.The physician elected to do thrombolysis and implanted a self-expanding bare metal stent.The blood flow was restored.Per the physician, the cause of the event was due to the patient¿s anatomy; tortuous anatomy and disruption of vessel distal to stent graft causing the occlusion.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Internal film review: from the films provided the cause of the stent graft occlusion could not be determined.Angiograms during implant and post-implant films were not available for return; therefore, the stent graft in-vivo configuration could not be determined and the blood flow dynamics could not be assessed.Films from the intervention were also not available.A pre-implant 3d-ct film report confirmed that the iliac arteries were non-tortuous with no apparent calcification.The common iliac artery diameter¿s could not be measured from the report, but likely contained irregular thrombus, and the external iliacs appeared to abruptly narrow, angulate, and were calcified at their origins; bilaterally.It is possible that the iliac anatomy may have contributed to the occlusion.This 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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Other relevant devices are: etlw1610c156e; s/n: (b)(4) use by date: (b)(4) 2019; upn # (b)(4) 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: 7036308
• Report Number: 2953200-2017-01790
• Device Sequence Number: 11016518
• Product Code: MIH
• UDI-Device Identifier: 00613994990983
• UDI-Public: 00613994990983
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 01/24/2018

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: 06/27/2019
• Device Model Number: ETBF3216C145E
• Device Catalogue Number: ETBF3216C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 11/29/2017; 01/18/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/15/2017; 01/24/2018
• 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: 68 YR