(b)(6) trial.It was reported that a vessel occlusion occurred.The patient underwent treatment with the eluvia device on (b)(6) 2017 as part of the (b)(6) trial.The following lesion was treated in the left limb: proximal, middle and distal superficial femoral artery (proximal popliteal artery not involved).The lesion was 220mm long, 100% stenosed with a proximal reference diameter of 6mm and distal reference diameter of 5mm.Pre-dilatation was performed using a balloon and the lesion was crossed through the true lumen.Three eluvia drug eluting vascular stents 6mm x 100mm, 6mm x 80mm, and 6mm x 80mm were implanted in the target lesion.Post-dilatation was performed using one balloon.The residual stenosis was 0% and there was no thrombus seen in the treated vessel at the end of the procedure.On (b)(6) 2018, an occlusion in the target vessel was discovered.The patient was hospitalized on (b)(6) 2018 for a percutaneous transluminal angioplasty treatment with a drug eluting balloon at the deep left femoral artery.The patient was discharged on (b)(6) 2018 and the event is reported as resolved with sequelae.
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