Model Number 10620 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Restenosis (4576)
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Event Date 12/28/2023 |
Event Type
Injury
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Event Description
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Synergy china registry.It was reported that the patient experienced stent thrombosis, acute st elevation myocardial infarction, acute heart failure and target vessel revascularization.In (b)(6) 2020, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to distal lad with 95% stenosis and was 12 mm long with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of 2.75 mm x 24 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal right coronary artery (rca) with 95% stenosis and was 8 mm long with a reference vessel diameter of 2.25 mm.The target lesion 2 was treated with pre-dilatation and placement of 2.25 mm x 12 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the subject was diagnosed with stent thrombosis, acute st elevation myocardial infarction (mi) anterior/septal, acute heart failure and target vessel revascularization and was hospitalized on the same day for further evaluation and treatment.Coronary angiography revealed an unobstructed and non-thrombosed rca and a 50% in-stent restenosis in the lad with numerous visible thrombus shadows, and 50% -70% stenosis at the first diagonal (d1) opening.The stenosis noted in proximal lad extending up to middle lad which had previously placed study device was treated with percutaneous coronary intervention (target vessel revascularization).Post intervention, the residual stenosis was noted to be 0%.Thirteen days later in (b)(6) 2024, the events were considered to be recovered and resolved and the subject was discharged on aspirin and ticagrelor.
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Manufacturer Narrative
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E1 initial reporter phone: (b)(6).
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Manufacturer Narrative
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E1: initial reporter phone: (b)(6).
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Event Description
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Synergy china registry: it was reported that the patient experienced stent thrombosis, acute st elevation myocardial infarction, acute heart failure and target vessel revascularization.On (b)(6) 2020, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to distal lad with 95% stenosis and was 12 mm long with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of 2.75 mm x 24 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal right coronary artery (rca) with 95% stenosis and was 8 mm long with a reference vessel diameter of 2.25 mm.The target lesion 2 was treated with pre-dilatation and placement of 2.25 mm x 12 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin and ticagrelor.On (b)(6) 2023, the subject was diagnosed with stent thrombosis, acute st elevation myocardial infarction (mi) anterior/septal, acute heart failure and target vessel revascularization and was hospitalized on the same day for further evaluation and treatment.Coronary angiography revealed an unobstructed and non-thrombosed rca and a 50% in-stent restenosis in the lad with numerous visible thrombus shadows, and 50% -70% stenosis at the first diagonal (d1) opening.The stenosis noted in proximal lad extending up to middle lad which had previously placed study device was treated with percutaneous coronary intervention (target vessel revascularization).Post intervention, the residual stenosis was noted to be 0%.Thirteen days later on (b)(6) 2024, the events were considered to be recovered and resolved and the subject was discharged on aspirin and ticagrelor.
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Search Alerts/Recalls
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