One zilver ptx v study stent was placed during the index procedure on (b)(6) 2015.The study lesion was the left distal sfa, 20 mm in length, with 75% diameter stenosis.There were two patent runoff vessels.The patient underwent pre-dilatation of study lesion with one inflation of a 5.0 x 40 mm balloon at 12 atm for 60 seconds.One zilver ptx v study stent was placed in the left distal superficial femoral artery via contralateral access.Post-stent dilatation was performed with three inflations of a 5.0 mm x 20 mm dilatation balloon at 20 atm for 20 seconds, 30 seconds, and 30 seconds.At the end of the case, there was 20% residual stenosis remaining in the study lesion, no thrombus was present.On the same day, the patient was discharged from the hospital taking aspirin and plavix.On (b)(6) 2016 (281 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention as previously reported.On (b)(6) 2017 (604 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention as previously reported.On (b)(6) 2018 (1185 days post-procedure), the patient complained of left lower extremity claudication, worsened claudication/rest pain.On (b)(6) 2018 (1197 days post-procedure), the patient underwent a secondary intervention as previously reported.On (b)(6) 2019 (1438 days post-procedure), the patient was diagnosed with an occlusion/restenosis within and proximal to the study lesion.The physician was "possibly" related to the study product.The pre-existing condition of peripheral arterial disease (pad) caused or contributed to the event.The patient continued taking aspirin and plavix.The secondary intervention was performed on (b)(6) 2019 (1478 days post-procedure).The pre-intervention diameter stenosis was occluded.The pre-intervention diameter stenosis diameter stenosis was occluded.The treatment provided was percutaneous, including atherectomy, use of a cutting balloon.The secondary intervention was deem successful with residual stenosis <50%.
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