Same case as mdr# 2134265-2018-05834 the patient was enrolled in the (b)(6) study with patient identifier (b)(6).It was reported that stent thrombosis and death occurred.In (b)(6) 2018, the patient presented with unstable angina (ccs classification: iib) and was referred for elective cardiac catheterization.Target lesion #1 was located in the mid right coronary artery (rca) with 80% stenosis and was 20 mm long with a reference vessel diameter of 3.5 mm.Target lesion #1 was treated with direct placement of 3.50 x 20 mm study stent.Following, post-dilatation residual stenosis was 0%.Target lesion #2 was located in proximal left anterior descending artery (lad) with 80% stenosis and was 16 mm long with a reference vessel diameter of 3.0 mm.Target lesion #2 was treated with direct placement of a 3.00 x 20 mm study stent.Following, post-dilatation residual stenosis was 0%.In (b)(6) 2018, the patient died.Primary cause of death was stent thrombosis and stroke.Since sudden death occurred, stent thrombosis was considered and assessed as possibly related to study device.A death certificate is not available and it is not known if an autopsy was performed.
|