Model Number RONYX30012UX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombus (2101)
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Event Date 09/24/2018 |
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 mid circumflex.The lesion exhibited moderate tortuosity and 95% stenosis.There was no damage noted to packaging.There were 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 predilated.Resistance was not encountered when advancing the device.No excessive force used during delivery.The device did not pass through a previously deployed stent.Initial procedure was due to an mi and the stent was successfully placed.Patient was then admitted to the er on the (b)(6) 2018 with st elevations.Upon secondary procedure physician noted distal thrombosis of the om coming off the circumflex stent.The om was wired and physician ballooned into the om and then the distal stent.Slow flow persisted, and patient was treated medically.Patient status is alive with injury.
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Manufacturer Narrative
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Mi was reported.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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