Model Number RONYX22518UX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)
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Event Date 04/12/2020 |
Event Type
Death
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During an index procedure four resolute onyx rx stents were implanted between the distal lad which had a chronic total occlusion and the prox lad which had no occlusion.Approximately 32 months later the patient suffered cardiogenic shock and chest pain.The patient was treated with medication.Within 24 hours the patient presented to er with w/c/o cp & sob; bradycardic followed by cardiac arrest.The patient died due to cardiogenic shock.Investigator assessed the event as possibly related to index device and anti-platelet medication.The sponsor assessed event as not related to the devices or antiplatelet medication.
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Manufacturer Narrative
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Additional information: the patient is a former smoker.The cec adjudicated the cardiac chest pain event as mi of unknown vessel occurred ((b)(6) 2020).Cec also adjudicated possible stet thrombosis.Patient age and ethnicity are updated.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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