Same case as mdr id: 2134265-2014-03553, 2134265-2014-03552, 2134265-2014-03973, 2134265-2014-03554, 2134265-2014-03748 and 2134265-2014-03749.It was reported that the stent collapsed.In 2007, four taxus express2 stents were implanted in an unspecified lesion.It was noted that the four stents ¿collapsed¿ and the patient experienced a myocardial infarction.The patient received an additional taxus express2 stent, 2.75x12mm taxus liberte stent and a 2.25x16mm taxus liberte atom stent to open the previously placed collapsed stents.However, it was noted that these stents also collapsed in the years following implantation.No additional patient complications were reported and the patient¿s current condition is fine.
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Device is combination product.(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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