On (b)(6) 2012, two ziv6-35-125-6.0-120-ptx and one ziv6-35-125-7.0-40-ptx were implanted in the right sfa of the patient.Dissection occurred and was untreated at that time.On (b)(6) 2013, angiography confirmed the thrombosis at the lesion where the stents were placed.Patient showed symptoms of worsened claudication, rest pain and persistent claudication.On (b)(6) 2014, pta and stent placement for thrombosis were performed.On (b)(6) 2014, there have been no further adverse effects to the patient reported as occurring as a result of this specific event.This report relates to 1x ziv6-35-125-6/0-120-ptx of lot #c778925.Reference also related mdr reports 3001845648-2014-00271 and 3001845648-2014-00273.
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