Catalog Number RONYX30026X |
Device Problems
Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intimal Dissection (1333)
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Event Date 07/18/2018 |
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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The index procedure was prompted by unstable angina.During the index procedure, two resolute onyx des were implanted in the lad.It was reported that a grade b dissection occurred in the lad during the procedure.The patient recovered.The investigator assessed the event as not related to the anti-platelet medication or to the device.The sponsor assessed the event as not related to the anti-platelet medication and possibly related to the index device.
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Manufacturer Narrative
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Image analysis summary: a short video clip was provided for analysis.The video shows contrast administered to the rca.Lesions are visible in the rca.There were no images suggesting stent under expansion.There were no images showing the reported dissection.There were no images of the reported lesion returned.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The prox lad had 90% stenosis.Calcification was mild to none.The mid lad had 90% stenosis.Calcification was mild to none.The 3.0x26mm resolute onyx stent was implanted at 18 atms in the proximal lad.The stent was not post-dilated.There was a 10% residual stenosis.Stent underexpansion was seen during oct imaging.The patient was discharged with no complication and no symptoms.No intervention was planned for the underexpanded stent.A medtronic device was not believed to have caused the previously reported dissection.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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