Catalog Number RONYX25026X |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Death (1802)
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Event Date 06/19/2018 |
Event Type
Death
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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 des was implanted in the circumflex.It was reported that a family phoned and informed that the patient died - unknown classification.Investigator assessed that the event is not related to index device or antiplatelets medication.
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Manufacturer Narrative
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Sponsor assessed the event as not related to the anti-platelet medication and possibly related to index device.If information is provided in the future, a supplemental report will be issued.
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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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It was reported that he patient suffered 'sepsis related to a possibly respiratory organ' 12 days prior to the patients death.The patient was 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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The ae term was updated to 'pneumonia due to broncho aspiration.' 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 event as death non-cardiovascular.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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