Same case as mdr id# 2134265-2017-04352, 2134265-2017-04353 and 2134265-2017-04355.(b)(4) study.It was reported that patient death and in-stent thrombus occurred.In (b)(6) 2016, the patient was referred for cardiac catheterization and subsequently the index procedure was performed.Target lesion #1 was located in the mid left anterior descending artery (lad) with 70% stenosis and was 26 mm long with a reference vessel diameter of 2.50 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.25 x 38 mm synergy ii stent.Following post dilatation, the residual stenosis was 0%.Target lesion #2 was located in the proximal lad with 80% stenosis and was 20 mm long with a reference vessel diameter of 3.00 mm.Target lesion #2 was treated with pre-dilatation and placement of a 2.5 x 28 mm synergy ii stent.Following post dilatation, the residual stenosis was 0%.Target lesion #3 was located in the first obtue marginal branch (om1) with 80% stenosis and was 16 mm long with a reference vessel diameter of 2.25 mm.Target lesion #3 was treated with pre-dilatation and placement of a 2.25 x 16 mm and a 2.25 x 12 mm synergy ii stent with 0% residual stenosis.The following day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient expired at home due to sudden "cardiac death", assumed to be attributable to de novo coronary thrombosis or in-stent coronary thrombosis, approximately 36 hours after stopping the anti-platelet drug plavix (clopidogrel).No death certificate is available and autopsy was not performed.
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