The device was not returned for evaluation.Two still images were provided and reviewed by the medical director.It was noted that it appeared as if the pictures provided were taken with the graft being partially deployed.The medical director also commented that there was a separate sheath lying outside the zfen delivery system and that sheath contains both a through-and-through wire as well as a guidewire which has cannulated the right renal artery.The medical director stated that: ¿the graft markers look like the anterior and posterior markers are aligned correctly (although can¿t tell if we¿re looking from the back or the front), but all the markers for both the right and left renal fenestrations are overlying one another on the patient¿s left side of the device¿ but does raise the possibility that the graft compression can cause all those markers to overlay one another, while the anterior and posterior markers are correct.This graft has very short spaces between stents, so a significant twist would be very unlikely, and a complete ¿candy-wrapper¿ 180 degree twist wouldn¿t happen.¿.The quality engineering manager reviewed the images provided and confirmed that the gold markers around the fenestrations were compressed in the left side of the sheath.A review of the device history record found that the work order for lot number ac1135171 appears complete and correct.The associated inspection record confirms that the device was manufactured to specification prior to shipment.The specifications were reviewed and there are a number of processes and checks in place to ensure that the graft is loaded in the correct orientation within the delivery system.The manufacturing team was made aware of this occurrence.Re-training for all personnel who perform tasks related to the reported event was performed.The instructions for use (ifu) supplied with the device was reviewed and it contains appropriate information relating to the implant procedure, potential adverse events, and inspections prior to use.There is no evidence to suggest that the user did not follow the ifu.A definitive root cause could not be determined from the investigation.Possible root cause(s) are: inadequate design, transportation, loading.
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