On (b)(6) 2013, pts with stenting of the left sfa of the patient with two zilver ptx devices was performed.The patient stayed overnight at the hospital and the next day the stents were occluded.The patient also had back problems and it was not clear from where the pains came from.Claudication also remained.On (b)(6) 2014, the physician carried out pta again in response to the occlusion of the stents.The physician discovered one zilver ptx stent was fractured and did an instent-stenting with a supera stent.The physician has reported a favorable outcome for the patient and no further adverse effects to the patient have been reported as occurring.This report specifically relates to the occlusion of one zilver ptx device.The reported occlusion of the second zilver ptx device is addressed within mdr report ref# 3001845648-2014-00332.The report of the fracture of one zilver ptx stent is addressed within mdr report ref# 3001845648-2014-00331.The information and images received relating to this event are currently being investigated.A follow up report will be submitted following the completion of the investigation.
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