Same case as 2134265-2015-04795 and 2134265-2015-04796.Pe-prove clinical study.It was reported that the patient died.In (b)(6) 2011, the patient was referred for cardiac catheterization.Target lesion #1 was a de novo lesion located in the distal left anterior descending artery (lad) with 90% stenosis and was 7mm long with a reference vessel diameter of 2.25mm.Target lesion #1 was treated with direct placement of a 2.25x8mm promus element ¿ stent.However after implantation of the stent, it was noted that there was a grade c vessel dissection in the lesion extending distally.The dissection was treated with placement of a 2.25x12mm promus element ¿ stent with 0% residual stenosis.Target lesion #2 was a de novo lesion located in the first obtuse marginal artery (om) with 90% stenosis and was 18mm long with a reference vessel diameter of 2.25mm.Target lesion #2 was treated with direct stent placement using a 2.25x20mm promus element ¿ stent with 0% residual stenosis.Two post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient died.No corrective actions have been taken for this event.The cause of death is acute pulmonary edema.
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