Catalog Number RONYX35038X |
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 07/09/2018 |
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, four resolute onyx des were implanted in the lad.On the same day, patient suffered from a possible pci related myocardial infarction (target vessel involved-lad).Event was treated with medication.Investigator assessed that the event was not related to index device or antiplatelets medication.Patient is 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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During the index procedure, only two resolute onyx des were implanted in the lad not four as previously reported.Cec adjudicated the event as not an event, mi preceded enrolment.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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