Model Number RONYX27534X |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Death (1802); Myocardial Infarction (1969); Renal Failure (2041); Cardiogenic Shock (2262)
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Event Date 07/06/2018 |
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 the index procedure, one resolute onyx des was implanted in the lad.Approximately four days post procedure, patient suffered a cardiogenic shock secondary to nstemi in the rca.Patient received blood transfusion and was intubated.Investigator assessed that the event was not related to antiplatelets medication, but possibly related to index device.Patient died.
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Manufacturer Narrative
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Lot number of index device received.Patient was admitted for acute pulmonary oedema secondary to end stage renal failure with the nstemi.Death was classified as non sudden cardiac death.If information is provided in the future, a supplemental report will be issued.
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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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Manufacturer Narrative
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Cec assessed the event as death - cardiac death.Likely heart failure in setting esrd.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Cec assessed the mi and stent thrombosis as no event.Cec commented that there was no clinical evidence of mi.No enzymes just cardiogenic shock.The patient suffered cardiac failure and died.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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