Same case as mdr# 2134265-2017-03331 and 2134265-2017-03332.(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient's qualifying condition was unstable angina.Prior to procedure, the patient was found to have abnormal fractional flow reserve indicative of ischemia and the patient was referred for cardiac catheterization.On the same day, the index procedure was performed.Target lesion #1 was located in the mid left anterior descending artery (lad) with 70% stenosis and was 16 mm long with a reference vessel diameter of 3.00 mm.Target lesion #1 was treated with pre-dilatation and placement of 3.00x20mm study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was located in the mid right coronary artery (rca) with 65% stenosis and was 10 mm long with a reference vessel diameter of 3.5 mm.Target lesion #2 was treated with pre-dilatation and placement of 3.50x12mm study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #3 was located in the proximal rca with 75% stenosis and was 12 mm long with a reference vessel diameter of 3.5 mm.Target lesion #3 was treated with pre-dilatation and placement of 3.50x20mm study stent.Following post-dilatation, residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient died on an unknown date and the cause of death was also unknown.
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