Catalog Number RONYX25015UX |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
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Event Date 12/14/2018 |
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 rx coronary drug eluting stent was attempted to be used to treat a de novo lesion in the proximal rca with 75% stenosis.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.It is reported that the device failed to cross the lesion and that a stent dislodgement occurred.The dislodged stent was removed from the patient.A 2.75x22mm resolute was then attempted but also failed to cross.The procedure was completed using a non-medtronic stent.No patient injury is reported.
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Manufacturer Narrative
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The dislodged stent was crushed in place.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: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were intact.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.There was no damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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