Same case as mdr id# 2134265-2015-03666, 2134265-2015-03667 and 2134265-2015-03668.(b)(4).It was reported that very late stent thrombosis occurred.In (b)(6) 2013, the patient was referred for cardiac catheterization which revealed four (4) target lesions.Target lesion #1 was located in the proximal right coronary artery (rca) extending into distal rca with 75% stenosis, and was 28mm long with a reference vessel diameter of 4.0 mm.Target lesion #1 was treated with pre-dilatation and placement of a 4.00 x 28mm study stent.Following intervention, residual stenosis was 0%.Target lesion #2 was located in the proximal rca extending into distal rca with 80% stenosis, and was 32mm long with a reference vessel diameter of 4.0 mm.Target lesion #2 was treated with pre-dilatation and placement of a 4.00 x 32mm study stent.Following intervention, residual stenosis was 0%.Target lesion #3 was located in the proximal rca extending into distal rca with 100% stenosis, and was 38mm long with a reference vessel diameter of 3.0mm.Target lesion #3 was treated with pre-dilatation and placement of 3.00 x 38mm study stent.Following intervention, residual stenosis was 0%.Target lesion #4 was located in the proximal rca extending into distal rca with 100% stenosis, and was 24mm long with a reference vessel diameter of 2.5mm.Target lesion #4 was treated with pre-dilatation and placement of 2.50 x 24mm study stent.Following intervention, residual stenosis was 0%.Seven days post index procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented with cardiac pain and was hospitalized.Four days post admission, coronary angiography revealed 80% stent thrombosis of the previously placed study stent from the proximal rca to the distal rca.On the same day, the patient was treated with percutaneous coronary intervention (pci).Following intervention, residual stenosis was 0%.Two days post intervention the event was considered as recovered/resolved and the patient was discharged on the same day.
|