An endurant ii stent graft system was implanted for the endovascular treatment of a 6.1 cm diameter abdominal aortic aneurysm.It was reported that during the index procedure, after deployment of aortic cuff for treatment of a persistent type ii endoleak and placement of endovascular anchors, the physician noticed the aortic cuff looked infolded and the supra renal stents did not appear to deploy correctly.This was confirmed with intravascular ultrasound.There were no endoleaks as a result of the cuff infolding at the end of the procedure.The physician stated the event was related to the device. no clinical sequelae were reported and the patient is being monitored.Film review analysis: review of 2 short videos during an angio intervention revealed that a talent aaa was seen positioned with an endurant aortic cuff placed approximately 1cm above the bifurcate aortic body.Several anchors were also seen placed within the aortic body and bifurcate.Ballooning was performed within the aortic body.After deflation, the ballooned stent graft did not appear to be fully apposed within the bifurcate aortic body.No contrast injections were seen in the video¿s therefore the patency of the graft lumens or any possible endoleak could not be assessed.A single still angio image without contrast showed the suprarenal stents from the endurant cuff; however, the reported suprarenal entanglement could not be confirmed (or ruled out) from this single image.The cause of the reported stent graft infolding and suprarenal stent entanglement could not be determined from the limited films provided.Images showing the deployment of the aortic cuff and removal of the cuff delivery system were not available for review.The non¿contrast images also made the assessment of the events and determination of the possible cause difficult.
|