Catalog Number RONYX30038W |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
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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 06/15/2018 |
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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One resolute onyx drug eluting stent was intended to be used to treat a severely calcified lesion in the rca with 80% diffuse mid-artery occlusion with thrombosis.The device was inspected with no issues.The lesion was pre-dilated with a 2.0mm x 20mm balloon.Resistance was encountered when advancing the device and excessive force was used.It was reported that the stent failed to cross the lesion and when removed was noted to be deformed.The lesion was then pre-dilated with a 3.0mm x 20mm balloon, guideliner was advanced and a 3.0mm x 38mm onyx stent was successfully placed followed by a more proximal 3.0mm x 38mm onyx stent and then another 3.50mm x 30mm onyx was placed in the proximal segment in the rca.No patient injury is 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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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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