Same case as mdr id 2134265-2018-01532.(b)(4) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient presented with stable angina.Subsequently, the patient was referred for cardiac catheterization and index procedure was performed.The target lesion was a bifurcated, de novo lesion located in the middle left anterior descending (lad) with 95 % stenosis and was 12 mm long with a reference vessel diameter of 2.25 mm.The lesion was treated with a placement of a 2.25x16mm promus element¿ plus study stent with 5% residual stenosis.Target lesion #2 was a de novo lesion located in the proximal lad with 70 % stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with direct placement of 2.50x16 mm promus element¿ plus study stent with 5% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was transferred to the study hospital for evaluation of elevated troponin level (0.990).A day prior to the transfer to the study hospital the troponin value was reported to be 1.010.The patient was hospitalized on the same day and was diagnosed with atrial fibrillation with rapid ventricular response (rvr) for which electrophysiologist was consulted.Post consultation, cardiac catheterization was planned.The patient had needles and pins sensations in her chest and could not perform any activity without getting extremely short of breath which appeared to be chronic and related to chronic aspiration.The patient was extremely malnourished due to dysphagia, relying only on liquids and baby food and had multiple treatments for problems following which had eventually worsen.The patient went into respiratory distress and her condition continued to decline.The patient was put into do not resuscitate status and it was decided that no aggressive management would be carried out.On the same day, the patient died.The cause of death was cardiorespiratory arrest.It was confirmed that autopsy was not performed.
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