It was reported that in-stent occlusion occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in the left distal superficial femoral artery (sfa) with 90% stenosis and was 30 mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with direct placement of a 6 mm x 40 mm study stent.Following post dilation, the residual stenosis was 0%.On (b)(6)2018, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject visited the site for protocol scheduled 24-month follow-up visit.(b)(6) classification assessed on (b)(6) 2020 was 0 (asymptomatic) and the ankle brachial index (abi) ratio was 1.Duplex ultrasound performed on (b)(6) 2020 revealed high grade in-stent occlusion of the left sfa.No action was taken to treat the event.Event was considered not recovered/ not resolved.
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