(b)(6).It was reported that the subject experienced symptoms of coronary atherosclerotic heart disease.In (b)(6) 2019, the index procedure was performed.The target lesion was located in the proximal right coronary artery (rca) extended to mid rca with 100% stenosis and was 30 mm long, with a reference vessel diameter of 3.4 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Nine days later, the subject was discharged on aspirin and other antiplatelet medications.In (b)(6) 2020, 322 days post index procedure, the subject presented with symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease and event was treated medically.Two days later, the event was considered recovering/resolving and the subject was discharged on aspirin and other antiplatelet medications.
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