Catalog Number RONYX22515UX |
Device Problems
Material Frayed (1262); Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/27/2018 |
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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It is reported that an attempt was made to use resolute onyx drug eluting stent to treat a lesion in a patient.It was reported that the stent failed to cross the lesion and became frayed.The procedure was completed using a 2.5x15 mm resolute onyx stent.No patient complications reported for this event.
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Manufacturer Narrative
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Additional information: the lesion stenosis, tortuosity and calcification were moderate.The device was inspected before use.The lesion was pre-dilated.Some resistance was noted while advancing the device to the lesion.Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 4th distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.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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Search Alerts/Recalls
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