Model Number 10623 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arteriosclerosis/ Atherosclerosis (4437); Heart Failure/Congestive Heart Failure (4446)
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Event Date 11/13/2022 |
Event Type
Death
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Event Description
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Synergy china registry.It was reported that the patient died.In (b)(6) 2020, the subject presented with unstable angina.The subject was referred for cardiac catheterization and the index procedure was performed the next day.The target lesion was located in the middle right coronary artery (rca) with 100% stenosis and was 38 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on clopidogrel and aspirin.In (b)(6) 2020, the staged procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long, with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 38 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.In (b)(6) 2022, the subject was diagnosed with coronary atherosclerotic cardiopathy and was hospitalized on the same day for further evaluation and treatment.The subject also experienced cardiac failure.Medication was given to treat the event.Three days later, the subject died, and the primary cause of death is coronary atherosclerotic cardiopathy.It is unknown if an autopsy was performed.
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Event Description
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Synergy china registry it was reported that the patient died.In september 2020, the subject presented with unstable angina.The subject was referred for cardiac catheterization and the index procedure was performed the next day.The target lesion was located in the middle right coronary artery (rca) with 100% stenosis and was 38 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on clopidogrel and aspirin.In october 2020, the staged procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long, with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 38 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.In november 2022, the subject was diagnosed with coronary atherosclerotic cardiopathy and was hospitalized on the same day for further evaluation and treatment.The subject also experienced cardiac failure.Medication was given to treat the event.Three days later, the subject died, and the primary cause of death is coronary atherosclerotic cardiopathy.It is unknown if an autopsy was performed.It was further reported that the main cause of death is cardiac failure.
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Search Alerts/Recalls
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