Catalog Number RONYX35015X |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Myocardial Infarction (1969)
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Event Date 04/05/2018 |
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 drug eluting stent was implanted in the cx and two resolute onyx drug eluting stents were implanted in the lad.On the same day, the patient suffered a procedure related mi.The investigator assessed the event as possibly related to the index device but not related to anti-platelet medication.Safety assessed the event as possibly related to the index device and causally related to the procedure but not related to anti-platelet medication.The patient recovered.
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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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Event was treated with medication.Cec adjudicated the event as non-q-wave mi in the lad (target vessel), 3rd umdi.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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