Model Number RONYX25012UX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Blood Loss (2597)
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Event Date 12/13/2019 |
Event Type
Injury
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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 index procedure, three resolute onyx drug eluting stents were implanted in the rca, r-pda and lad.Three euphora pta balloons were also used in these vessels.Approximately 2 weeks post procedure, patient suffered gastroenteritis with chest pain.Safety commented that gi bleed occurred.Patient was on dapt 24 hours prior to event.Sponsor assessed event is not related to device but possibly related to anti platelet medication.
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Manufacturer Narrative
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Additional information: event term was updated to viral gastroenteritis.Patient recovered.Event was treated with medication.Investigator assessed that the event was not related to index device or antiplatelets medication.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The index procedure was prompted by myocardial infarction.The patient has medical history of previous mi, pci, hyperlipidemia and hypertension.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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