Model Number RONYX30022X |
Device Problems
Failure to Advance (2524); Material Deformation (2976); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2018 |
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 was reported that an attempt was made to use a resolute onyx drug eluting stent to treat a lesion in a non-tortuous proximal r-pda with moderate calcification with 80% stenosis.No abnormalities were noted in the patient¿s anatomy.No damage was noted to packaging.The device was inspected with no issues noted.Negative prep was not performed.The lesion was predilated.The device did not pass through a previously deployed stent.Resistance was noted when advancing the device, and excessive force was not used.It was reported that the stent failed to cross the lesion despite multiple attempts and techniques.When it was removed from the patient, a protruded stent was noted.Another resolute onyx device was used to complete the procedure.No patient complications reported for this event.
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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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Product analysis summary: there were two kinks on the catheter 22.2cm and 51.2cm distal to the strain relief.The stent was positioned on the balloon between the marker bands as per specifications.No deformation was evident to the stent wraps.Deformation was evident to the distal tip.The 0.015 mandrel would not load through the guidewire lumen due to hardened blood in the catheter.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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