Same case as mdr id: 2134265-2018-04194.(b)(4) clinical study.It was reported that cardiogenic shock and stent fracture occurred.In (b)(6) 2017, the patient presented emergently with complaints of midsternal chest pain and hypoxia, which improved with medications in the emergency.Physical examination revealed regular rhythm and systolic murmur.The patient was hospitalized for further evaluation and management.At the time of the event, the patient was on baby aspirin and lasix which were continued further.Electrocardiogram (ecg) revealed marked st abnormality due to possible lateral subendocardial injury.Chest x ray revealed elevated right diaphragm.Cardiac enzymes were elevated consistent with protocol definition of myocardial infarction.The patient was diagnosed with non-st segment elevation acute coronary syndrome.The following day, ecg revealed left ventricular hypertrophy with repolarization abnormality and t wave inversion.Three days from hospitalization, selective coronary angiography was performed which revealed 80% stenosis in left main coronary artery (lmca).The lesion was treated with placement of a 3x12mm promus stent and 60% stenosis in proximal left anterior descending artery(lad) which was intervened with a 3x16mm promus stent.Subsequently, retroperitoneal bleeding was noted at the site of coronary catheterization.Drop in hemoglobin level was also observed with acute blood loss anemia.The patient was transfused with 6 units of packed red blood cells ( prbc) post which hemoglobin level was stable.Valve academic research consortium (varc) bleeding classification was life threatening or disabling.Computed tomography scan of abdomen revealed right retroperitoneal hemorrhage measuring approximately 16x3x6cm in size.The vascular event was related to the major bleed retroperitoneal bleed post percutaneous coronary intervention heart catheterization.One day post procedure, excimer laser coronary atherectomy of the lmca was planned.During the procedure, a stent fracture was noted in the lmca due to which the laser catheter (manufacturer unknown) was unable to pass beyond the stent.Furthermore, an angioplasty with angioscope balloon was performed in the mid to distal lmca and the proximal lad.Then, it was finally treated with balloon angioplasty.Subsequently, angiography demonstrated grade iii timi flow.Post stent support angioplasty, the post operative care was complicated and the subject developed cardiogenic shock.The patient was transferred to intensive care unit (icu) for further management and care.Within several days, the patient¿s condition improved; hence, the patient was transferred to the floor.A week after, the bleeding complication and vascular complications were considered to be recovered/ resolved and the patient was discharged home.
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