It was reported that a total occlusion of the study stent occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the (b)(6) clinical trial.The target lesion, located in the middle superficial femoral artery (sfa) of the right leg had a 6mm reference vessel diameter proximally and distally, and a total length of 80mm visually estimated.The target lesion was 100% occluded and crossed through true lumen.Pre-dilatation was performed using one balloon.Afterwards one 6x100mm eluvia stent was implanted.Post-dilatation was performed using one balloon, and 0% residual stenosis remained.No thrombus was seen at the end of procedure.On (b)(6) 2019, a total occlusion of the implanted study stent in the right sfa was observed.An intervention was performed.The event was reported as recovered as of (b)(6) 2019.
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