Same case as mdr id 2134265-2018-04060 and 2134265-2018-04061.(b)(6) clinical study.It was reported that non-st elevation myocardial infarction (nstem) and death occurred.In (b)(6) 2013, the patient presented due to unstable angina and myocardial infarction.Subsequently, angiography and the index procedure were performed.Target lesion #1 was located in the proximal segment (ostial lesion) of saphenous vein graft (svg) to right posterior descending artery (rpda) with 80% in-stent restenosis (isr) of a previously deployed unknown drug-eluting stent (des) and was 35 mm long with a reference vessel diameter of 3.5 mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.50 x 38 mm promus element plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.Target lesion #2 was a de novo lesion located in the mid segment of svg to rpda with 70% isr of a previously deployed unknown des and was 35 mm long with a reference vessel diameter of 3.0 mm.Target lesion #2 was treated with direct stent placement using a 3.00 x 38 mm promus element plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.Target lesion #3 was a de novo lesion located in the distal segment of svg to rpda with 90% stenosis and was 6 mm long with a reference vessel diameter of 3.0 mm.Target lesion #3 was treated with direct stent placement using a 3.00 x 8 mm promus element plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, the patient presented with complaints of lower extremity edema and shortness of breath.An elevation in cardiac enzyme was noted.The patient was diagnosed with nstemi and referred to the hospital for further evaluation.The patient had code status of do not resuscitate (dnr) and as the patient had a risk of renal failure (esrd secondary to lupus nephritis status post renal transplant) coronary angiogram was deferred.It was decided to treat the nstemi medically and to provide comfort care to the patient.During the hospitalization the patient had atrial fibrillation which was treated with medications, severe metabolic acidosis which was treated with electrolyte replacement and anemia with hemoglobin.No medications were given in response to nstemi.Eleven days after, the event nstemi was considered to be resolved.On the same day the patient was discharged from the hospital and was transferred to the transitional care unit (tcu) for continued rehab with palliative care.In (b)(6) 2018 while in tcu the patient's health started to decline due to worsening heart failure and the patient was placed on hospice care.It was reported that the patient was brought home and on the next day, the patient was found expired at home.The patient expired due to worsening heart failure.The cause of death was congestive heart failure.
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