Catalog Number RONYX35022UX |
Device Problems
Material Deformation (2976); Migration (4003)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 12/05/2018 |
Event Type
Injury
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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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A resolute onyx coronary drug eluting stent (3.50 x 22 mm) was implanted at a separate facility without any issues reported.Approximately two months later the right coronary artery (rca) exhibited severe tortuosity and severe calcification with 98% stenosis distal to the existing resolute onyx.The artery was described as a shepherds crook rca ¿ tortuous calcified - multiple bends.A guideliner and launcher were used with deep intubation causing the guideliner to engage the pre existing onyx and deformation and displacement to the previously placed onyx occurred requiring a stent to fix it ( moved approximately 3-5 mm forward in the proximal).The procedure required great back-up proximal to fix the entire artery.A non-medtronic stent was used to complete the procedure.The patient was discharged two days post procedure.
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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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