Catalog Number RONYX22534X |
Device Problems
Inflation Problem (1310); Activation, Positioning or Separation Problem (2906)
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Patient Problems
Death (1802); Myocardial Infarction (1969); Ventricular Fibrillation (2130)
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Event Date 12/21/2018 |
Event Type
Death
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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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An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a severely tortuous and calcified lesion located in the mid rca.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that there were inflation difficulties during balloon inflation at nominal pressure.Patient death is reported to have occurred 4 days post procedure.It is indicated that the cause of death was acute myocardial infarction, vf.
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Manufacturer Narrative
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Relevant history: mild amnesia, multiple previous pci's, epilepsy.Additional information: there was evidence of restenosis or thrombus suspected in the ramus which was treated successfully.The same inflation device was used with other devices pre and post the inflation difficulties.The stent had only partially expended at both proximal and distal edges.It was not the case that device could not expand fully in the lesion due the vessel morphology, or based on the inflation pressure applied.The stent was not implanted.The physician assessed that there is no connection between the event or myocardial infarction and the relevant device.The patient was on dapt at time of the event.Product analysis summary: there was no contrast visible in the balloon or inflation lumen.The balloon folds had partially expanded.The distal and proximal stent wraps were not flared.Negative prep was performed with no issues noted.The device was inflated to nominal pressure of 12atm with no issues noted.The balloon-maintained pressure.The stent deployed with no issues noted.No damage was 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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