Catalog Number RONYX50018UX |
Device Problems
Fracture (1260); Material Deformation (2976)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 10/30/2018 |
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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During a procedure one resolute onyx rx coronary drug eluting stent was used to successfully treat a near occlusion of a non-medtronic stent previously implanted in the left pulmonary artery (lpa).During the same procedure a transcatheter pulmonary bio prosthetic valve (melody valve) was implanted.Post implantation of the melody valve the resolute onyx stent was noted to have become compressed and fractured therefore the stent was re-crossed and re-ballooned using a 4.5 and 5mm nc balloon at a high pressure.No additional adverse patient effects were 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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