(b)(6) clinical study.Same case as mfr report#: 2134265-2018-00107.It was reported that post a coronary artery drug eluting stenting treatment procedure, the patient had cardiac arrest and expired.In (b)(6) 2013, the patient presented due to unstable angina (braunwald classification: iiib) and myocardial infarction and was referred for cardiac catheterization.The first target lesion was a de novo lesion located in the 1st obtuse marginal branch (om1) with 80% stenosis and was 20 mm long with a reference vessel diameter of 2.5 mm.It was treated with pre-dilatation and placement of a 2.50 x 28 mm promus element plus stent, with 0% residual stenosis and timi 3 flow.The second target lesion was a bifurcated de novo lesion located in the left main coronary artery (lmca) with 60% stenosis and was 15 mm long with a reference vessel diameter of 3.0 mm.It was treated with pre-dilatation and placement of a 3.00 x 20 mm promus element plus stent.Following post dilatation, residual stenosis was 0% and timi 3 flow.The patient was discharged on aspirin and clopidogrel the next day.In (b)(6) 2017, the patient was hospitalized due to cardiac arrest.The patient expired four days later and the cause of death was cardiac arrest.
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