Model Number RONYX30030UX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Blood Loss (2597)
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Event Date 01/20/2020 |
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 the index procedure one resolute onyx des was implanted in the lad.One resolute onyx des was also implanted in the 1st obtuse marginal during a staged procedure.Approximately 14 months later the patient suffered rectal bleeding.Patient was on dapt 24 hours prior to event.Patient recovered.The investigator assessed the event as possibly related to the anti-platelet medication and not related to the device.
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Manufacturer Narrative
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Event date was 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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