Model Number RONYX22518UX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Blood Loss (2597)
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Event Date 12/23/2018 |
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 stent was implanted into the rca.Approx 4 days post index procedure, the patient suffered rectal bleeding.The patient was on dapt at the time of the event.The investigator assessed the event as not related to the index device but possibly related to anti-platelet medication.The event is unresolved.
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Manufacturer Narrative
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Patient presented with anemia and was treated with blood transfusion and a colonoscopy.Patient recovered from rectal bleeding.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The patient was also treated with medication.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Cec adjudicated the bleeding event as barc type 3a.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: event date updated.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: event date 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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