Model Number 10621 |
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 05/05/2020 |
Event Type
Injury
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Event Description
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(b)(6) registry it was reported that coronary atherosclerotic heart disease and restenosis 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 1 was located in the proximal left anterior descending artery (lad) extending up to mid lad with 70 % stenosis and was 47 mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.50mmx 28 mm stent overlapped with another 2.75 mm x 24 mm synergy stent system.Post-dilatation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left circumflex artery (lcx) with 90% stenosis and was 25mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 28 mm synergy stent system.Post-dilatation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin, clopidogrel and ticagrelor.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.On the following day, the subject was referred for coronary angiography which revealed 85% proximal stenosis in lcx extending up to distal lcx which had previously placed study device.The stenosis was treated with percutaneous coronary intervention (pci) and target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.Non-target vessel revascularization was also performed.At the time of reporting, the event was considered recovering/resolving.Two days later, the subject was discharged.
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Manufacturer Narrative
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B5.Describe event or problem- corrected and updated.
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Event Description
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Synergy china registry.It was reported that coronary atherosclerotic heart disease and restenosis 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 1 was located in the proximal left anterior descending artery (lad) extending up to mid lad with 70 % stenosis and was 47 mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.50mmx 28 mm stent overlapped with another 2.75 mm x 24 mm synergy stent system.Post-dilatation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left circumflex artery (lcx) with 90% stenosis and was 25mm long, with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 28 mm synergy stent system.Post-dilatation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin, clopidogrel and ticagrelor.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.On the following day, the subject was referred for coronary angiography which revealed 85% proximal stenosis in lcx extending up to distal lcx which had previously placed study device.The stenosis was treated with percutaneous coronary intervention (pci) and target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.Non-target vessel revascularization was also performed.At the time of reporting, the event was considered recovering/resolving.Two days later, the subject was discharged.It was further reported that in (b)(6) 2020, the 85% target lesion was extending to mid lcx and not distal as previously reported.The rationale of intervention was angiographic finding without symptoms or objective signs of ischemia.
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Search Alerts/Recalls
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