Device is a combination product.Device evaluated by mfr.: 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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Same case as mdr id: 2134265-2014-02462.(b)(4) clinical study.It was reported that ischemic cardiomyopathy and patient death occurred.On (b)(6) 2012, the patient presented due to stable angina and was referred for cardiac catheterization.The index procedure was performed.The target lesion was a de novo, bifurcated lesion located in the 2nd obtuse marginal with 99% stenosis and was 14 mm long with a reference vessel diameter of 2.5 mm.Subsequently, the lesion was treated with pre-dilatation and placement of a 2.50 mm x 16 mm and 2.25 mm x 8 mm ion stent.Following post dilatation, residual stenosis was 0%.Seven days post procedure, the patient was discharged on aspirin and clopidogrel.On (b)(6) 2012, the patient was diagnosed with ischemic cardiomyopathy and was hospitalized.On the same day, the patient died.
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