Model Number RONYX27515UX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
ST Segment Elevation (2059); Thrombus (2101)
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Event Date 09/12/2018 |
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 implanted in the distal circumflex.The lesion exhibited 95% stenosis.There was no damage noted to the packaging.There was no issues noted when removing the device from the hoop.Negative prep was not performed.The device was inspected prior to use with no issues noted.The lesion was pre-dilated.Resistance was not encountered during advancement.No excessive force used during delivery.It was reported that there was a successful initial implant.Closed groin access.Patient half an hour later had inferior st elevation.Patient was brought back into procedure room for investigation.Noted acute stent thrombosis.Ivus performed.Noted that stent needed to be post dilated for better apposition with nc balloon.Initial deployment at nominal pressure only.Patient discharged and stable.
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Manufacturer Narrative
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The stent was fully apposed when initially deployed.The stent was not post-dilated.The patient was on dapt when this thrombotic event occurred.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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