Model Number 10622 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Restenosis (4576)
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Event Date 06/15/2021 |
Event Type
Injury
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Event Description
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Synergy china registry.It was reported that unstable angina occurred.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to distal lad with 100% stenosis and was 60 mm long, with a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of 2.25 mm x 32 mm and 2.50 mm x 32 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.At the time of reporting, the outcome of the event was recovering and resolving.Four days later, the subject was discharged on aspirin and ticagrelor.
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Event Description
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Synergy china registry.It was reported that unstable angina occurred.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to distal lad with 100% stenosis and was 60 mm long, with a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of 2.25 mm x 32 mm and 2.50 mm x 32 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.At the time of reporting, the outcome of the event was recovering and resolving.Four days later, the subject was discharged on aspirin and ticagrelor.It was further reported that in (b)(6) 2021, the target vessel revascularization (tvr) was recommended to treat the event.The subject was referred for coronary angiography which revealed 30% stenosis in proximal lad extending up to distal right coronary artery (rca) was treated with tvr.The rationale of intervention was angina.
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Event Description
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Synergy china registry.It was reported that unstable angina occurred.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to distal lad with 100% stenosis and was 60 mm long, with a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of 2.25 mm x 32 mm and 2.50 mm x 32 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In june 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.At the time of reporting, the outcome of the event was recovering and resolving.Four days later, the subject was discharged on aspirin and ticagrelor.It was further reported that in june 2021, the target vessel revascularization (tvr) was recommended to treat the event.The subject was referred for coronary angiography which revealed 30% stenosis in proximal lad extending up to distal right coronary artery (rca) was treated with tvr.The rationale of intervention was angina.It was further reported that in june 2021, the 30% stenosis was only in the proximal lad which was previously placed with study stent was treated with coronary artery bypass graft.The rationale of intervention were angina and symptoms of ischemia.
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Event Description
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Synergy china registry it was reported that unstable angina occurred.In october 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to distal lad with 100% stenosis and was 60 mm long, with a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of 2.25 mm x 32 mm and 2.50 mm x 32 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In june 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.At the time of reporting, the outcome of the event was recovering and resolving.Four days later, the subject was discharged on aspirin and ticagrelor.It was further reported that in june 2021, the target vessel revascularization (tvr) was recommended to treat the event.The subject was referred for coronary angiography which revealed 30% stenosis in proximal lad extending up to distal right coronary artery (rca) was treated with tvr.The rationale of intervention was angina.It was further reported that in june 2021, the 30% stenosis was only in the proximal lad which was previously placed with study stent was treated with coronary artery bypass graft.The rationale of intervention were angina and symptoms of ischemia.It was further reported that in june 2021, the stenosis in the proximal lad was 95% which was treated with coronary artery bypass graft with residual stenosis of 0%.
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Search Alerts/Recalls
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