Same case as mdr id# 2134265-2017-01657.(b)(4) clinical study.It was reported that the cec adjudicated this event as non-st segment elevation myocardial infarction (nstemi).In (b)(6) 2012, the patient presented due to stable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed on the same day.The target lesion was a de novo and ostial lesion located in the proximal lad extending to mid lad with 70% stenosis and was 50 mm long with a reference vessel diameter of 3.50 mm.The target lesion was treated with direct placement of a 3.50x28mm promus element¿ plus stent and a 3.00x28mm promus element¿ plus stent in overlapping manner.Following post-dilatation, the residual stenosis was 0%.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented to the emergency room with shortness of breath and chest pressure.Her symptoms being constant have fluctuated in intensity.The course/duration of symptoms was worsening.She was found to be in acute pulmonary edema with acute respiratory failure complicated by anemia.Subsequently, patient was also diagnosed with hypertensive crisis, congestive heart failure (chf) exacerbation and acute renal failure.Electrocardiogram (ecg) revealed non specific intraventricular conduction delay with left ventricular hypertrophy (lvh) with strain pattern.There were anterior q waves without convincing evidence to suggest an st segment elevation myocardial infarction (stemi).Chest x-ray revealed cardiomegaly with bilateral pulmonary edema.The following day, ecg revealed st and t wave abnormality, consider inferior ischemia and anterolateral ischemia.Cardiac enzymes were found to be elevated and site reports an event of mi.Subsequently, cardiac catheterization was recommended.The patient was placed on a lasix drip for her longstanding history of renal failure.The patient continued to improve, was able to be transitioned off a lasix drip on to oral diuretics and had her hypertensive medications adjusted in order to continue to improve her cardiomyopathy and her systolic and diastolic dysfunction.The patient after diuresing had her acute respiratory failure and acute pulmonary edema resolved.In (b)(6) 2016, the patient underwent left heart catheterization showing previously placed lad stents were widely patent, no significant main branch obstructive coronary artery disease (cad), severe diffuse distal "pruning" of the entire branch vessel vasculature, preserved lv systolic function.In view of her catheterization, no disease amenable to percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg) was recommended and therefore aggressive medical management was initiated.After seven days, the events were considered resolved and subject was discharged on aspirin.
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