Catalog Number RONYX27526X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stroke/CVA (1770)
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Event Date 11/05/2018 |
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, two resolute onyx drug eluting stents were implanted in the lad.9 days post index procedure, the patient suffered cerebral infarction.The patient died 9 days later.The patients death was classified as non cardiac death.The investigator and safety assessed the event as not related to the index device or anti-platelet medication.
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Manufacturer Narrative
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Event date changed to the (b)(6) 2018.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: cec adjudicated the death event as vascular death and commented that the patient died from stroke.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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