On (b)(6) 2013, pta with stenting of the left sfa of the patient with two zilver ptx devices was performed.The patient stayed overnight at the hosp 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 a instent-stenting with a supera stent.The physician has reported a favourable outcome for the patient and no further adverse effects to the patient have been reported as occurring.This report specifically relates to the fracture of one zilver ptx device.The reported occlusion of the zilver ptx devices is addressed within mdr reports mdr ref#:3001845648-2014-00332 & 3001845648-2014-00333.
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