Catalog Number RONYX35015UX |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/12/2018 |
Event Type
malfunction
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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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An attempt was made to use a resolute onyx drug eluting stent to treat a lesion that exhibited severe calcification.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.Resistance was encountered advancing the device however excessive force was not used.It was reported that stent deformation occurred during positioning/advancement.The procedure was completed with another onyx of the same size.No patient injury reported.
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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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Search Alerts/Recalls
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