Catalog Number RONYX35038X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); Stenosis (2263); Patient Problem/Medical Problem (2688)
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Event Date 02/09/2019 |
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 the index procedure one resolute onyx stent was implanted into the lad.Approx 8 months post index procedure, the patient suffered a late presentation anterior mi.The mi occurred in the target vessel- lad.Instant restenosis of the stent in the lad was observed.The patient was treated with pci, surgical intervention and medication.The patient recovered.The investigator reported that the event is possibly related to the device and the anti platelet medication.
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Manufacturer Narrative
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The patient was not treated with pci.The patient had a coronary angiogram.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 not treated with surgical procedure.The patient was treated with pci.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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