Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.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: 2134265-2016-12137, 2134265-2016-12139, 2134265-2016-12140.(b)(4) study.It was reported that the patient died.In (b)(6) 2012, the patient presented with unstable angina and was diagnosed with non-st segment elevation myocardial infarction (nstemi).The patient was referred for cardiac catheterization.Subsequently, the index procedure and coronary angiography were performed.Target lesion # 1 was located in the 1st diagonal with 90% stenosis and was 22mm long with a reference vessel diameter of 2.5mm.Target lesion # 1 was treated with pre-dilatation and placement of a 2.50x24am promus element plus study stent.Following post dilatation, residual stenosis was 0%.Target lesion # 2 was located in the 1st obtuse marginal with 99% stenosis and was 23mm long with a reference vessel diameter of 2.5mm.Target lesion # 2 was treated with pre-dilatation and placement of 2.75 x 8mm and 2.50 x 24mm promus element plus study stents in overlapping fashion.Following post dilatation, residual stenosis was 0%.Target lesion # 3 was located in the distal right coronary artery (rca) with 99% stenosis and was 22mm long with a reference vessel diameter of 2.75mm.Target lesion # 3 was treated with pre-dilatation and placement of a 2.75 x 24mm promus element plus study stent.Following post dilatation, residual stenosis was 0%.Two days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient expired and the cause of death was unknown.
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