Model Number 10623 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
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Event Date 12/16/2020 |
Event Type
Injury
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Event Description
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Same case as pr id# (b)(4).Synergy (b)(4) registry it was reported that coronary atherosclerotic heart disease occurred.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal right coronary artery (rca) extending up to right posterior descending artery (r-pda) with 80% stenosis and was 61 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 28 mm overlapped with another 3.00 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.On the following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Percutaneous transluminal coronary angioplasty (ptca) was performed in mid rca and proximal left anterior descending artery (lad).Three days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was recovering or resolving.
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Event Description
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Synergy china registry.It was reported that coronary atherosclerotic heart disease occurred.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal right coronary artery (rca) extending up to right posterior descending artery (r-pda) with 80% stenosis and was 61 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 28 mm overlapped with another 3.00 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.On the following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Percutaneous transluminal coronary angioplasty (ptca) was performed in mid rca and proximal left anterior descending artery (lad).Three days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was recovering or resolving.It was further reported that the event would qualify for clinical events committee (cec)- target vessel revascularization (tvr).In (b)(6) 2020, coronary angiography revealed 90% stenosis in mid rca, which had previously placed study device.It was treated with percutaneous coronary intervention-target vessel revascularization (pci-tvr).Post intervention, residual stenosis was 0%.
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Event Description
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Synergy china registry.It was reported that coronary atherosclerotic heart disease occurred.In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal right coronary artery (rca) extending up to right posterior descending artery (r-pda) with 80% stenosis and was 61 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 28 mm overlapped with another 3.00 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.On the following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Percutaneous transluminal coronary angioplasty (ptca) was performed in mid rca and proximal left anterior descending artery (lad).Three days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the event was recovering or resolving.It was further reported that the event would qualify for clinical events committee (cec)- target vessel revascularization (tvr).In (b)(6) 2020, coronary angiography revealed 90% stenosis in mid rca, which had previously placed study device.It was treated with percutaneous coronary intervention-target vessel revascularization (pci-tvr).Post intervention, residual stenosis was 0%.It was further reported that the rationale for tvr is angina and symptoms of ischemia.Furthermore, it was noted that the vessel treated during baseline surgery was restenosis this time.
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Search Alerts/Recalls
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