It was reported that a vessel dissection occurred, requiring additional intervention.On (b)(6) 2021, the subject was enrolled into (b)(6) study and the index procedure was performed on the same day.A target lesion located in the right distal superficial femoral artery (sfa) had 95% occlusion, reference vessel diameter of 4mm, length of 30mm, and it was classified as a tasc ii a lesion.The target lesion was treated with a 2.1/3.0mm jetstream catheter.The residual stenosis post jetstream atherectomy was 100%.Post treatment, percutaneous transluminal angioplasty (pta) was performed, with 0% final residual stenosis.On (b)(6) 2021, during the index procedure, post treatment of target lesion with jetstream catheter, an f-type dissection of the sfa target lesion was noted.Pta and stenting were performed in the target vessel to treat the event.On (b)(6) 2021, the event was considered to be recovered/resolved.On (b)(6) 2021, the subject was discharged on aspirin and clopidogrel.
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