The patient was enrolled in the (b)(6) clinical study.It was reported that in-stent restenosis (isr) and stent fracture occurred.On (b)(6) 2016, the index procedure was performed.The target lesion was located in the right mid superficial femoral artery (sfa) extending to the distal sfa.The target lesion was 90% stenosed, 140mm long, with a proximal reference vessel diameter of 6.00mm and distal vessel diameter of 5.00mm, and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and a 6x150mm eluvia stent was implanted.The target lesion was then treated with post-dilatation and residual stenosis was 5%.The patient was discharged the following day with dual antiplatelet therapy.On (b)(6) 2018, the patient presented for a protocol 24 month follow-up visit.An ultrasound revealed isr in the right sfa.An x-ray was performed which revealed grade ii multiple tine fracture on the distal part of the stent.It was reported that the stent fracture was not observed in the overlap zone.On (b)(6) 2018, the patient was hospitalized for planned intervention.On (b)(6) 2018, the right mid sfa was treated with balloon angioplasty.The ostium and proximal sfa was treated with drug coated balloon angioplasty.On (b)(6) 2018, the patient was discharged from the hospital.
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