Evolve ii.It was reported there was a patient death.In (b)(6) 2013 the subject presented with stable angina.Prior to procedure, the subject was found to have abnormal stress test or imaging stress test indicative of ischemia and the subject was referred for cardiac catheterization.Target lesion #1 was located in the ramus with 90% stenosis and was 22 mm long with a reference vessel diameter of 2.5 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.50 x 28 mm study stent.Following post-dilatation, residual stenosis was noted to be 0%.The next day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient died.The cause of death was documented to be congestive heart failure.It was added that death certificate was unavailable and that the cause of death couldn't be confirmed beyond the obituary note.
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