Catalog Number RONYX27538X |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/28/2018 |
Event Type
malfunction
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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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During a procedure a resolute onyx rx coronary drug eluting stent was used to treat a lesion in the mid left anterior descending artery (lad).It was reported that a stent fracture (type 2) was noted post implantation of the stent.
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Manufacturer Narrative
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The target lesion was in the prox lad.The prox lad had 80% stenosis.The prox lad was not tortuous or calcified.The lesion was pre-dilated.The stent was implanted in the prox lad to 16 atm.The stent was postdilated to 8 atm.Kissing balloon technique was used for post dilation.No device malfunction occurred or is suspected, however it was reported that a stent fracture (type 2) was noted post implantation of the stent.The patient was discharged the next day.It was subsequently reported that corelab updated their assessment and confirmed that no stent fracture took place.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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