It was reported that a dissection occurred during the index procedure.The subject underwent treatment with two ranger drug-coated balloons on 16-oct-2023 as a part of the elegance clinical trial.The target lesion was in left distal superficial femoral artery extending up to left proximal popliteal artery with 6 mm proximal reference vessel diameter, 5 mm distal reference vessel diameter, and a lesion length of 60 mm.The lesion had 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, atherectomy was performed by using a 5.5 mm diameter non-boston scientific atherectomy device and pre-dilation was performed by using a 4.0 mm x 120 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon.Treatment of target lesion was performed by dilation using 5 mm x 120 mm and 6 mm x 100 mm ranger drug-coated balloons.Post-target lesion treatment was performed by placement of 5.0 mm x 40 mm innova drug-eluting stent and dilation using a 7.0 mm x 40 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon and a 5.0 mm x 120 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon.Following treatment, the final residual stenosis was noted to be 10%.On the same day of index procedure, during the treatment of the target lesion, a dissection (grade a) was observed related to 6.0 mm x 100 mm ranger drug-coated balloon treatment.In response to the event, additional balloon dilation was performed that resolved the issue.
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