Model Number RONYX20015UX |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/26/2020 |
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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During a procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a severely tortuous, severely calcified lesion located in the mid obtuse marginal (om).The device was inspected with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that stent dislodgement occurred during delivery to/at a lesion.It was stated that an attempt was made to recapture with a wire but the wire could not cross and the stent could not be retrieved.The stent remains in the patients om.The patient was reported to be alive with no 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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Search Alerts/Recalls
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