It was reported that there was a vessel dissection.An additional device was required to treat the dissection.The subject underwent treatment with the eluvia drug-eluting stents and ranger drug-coated balloons on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery, left distal superficial femoral artery, left proximal popliteal artery and left mid popliteal artery with 6.5 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length of 480 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study devices, laser atherectomy was performed using 1.5 mm non-boston scientific otw device, pre-dilation was performed using 3 mm x 100 mm and 6 mm x 240 mm non-boston scientific otw pta balloon and two 6 mm x 60 mm mustang pta balloons.Treatment of target lesion was performed by the placement of study devices of size 7 mm x 120 mm and 7 mm x 150 mm eluvia drug eluting stents and dilation using study devices, two 6 mm x 200 mm and one 6 mm x 40 mm of ranger drug-coated balloons.Post treatment of target lesions with study device, shockwave lithotripsy was performed using 6 mm x 60 mm non-boston scientific lithotripsy device and following post dilation with 6 mm x 60 mm mustang pta balloon, the final residual stenosis was noted to be 40%.On (b)(6) 2023, on the same day of index procedure, during the treatment of the target lesion, dissection of grade b was noted due to ranger drug-coated balloon.Which specific ranger drug-coated balloon led to dissection was unknown.In response to the complication, a bailout stent was placed.Post treatment, the final residual stenosis was noted to be 40%.The complication of dissection was resolved on the same day, and the subject was discharged on aspirin.
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