Catalog Number RONYX40038X |
Device Problems
Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/11/2019 |
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 an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a severely tortuous and calcified lesion exhibiting 80% stenosis located in the ostium of the left main (lm) coronary artery.The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that the stent deformed and lengthened in vivo and that the stent also dislodged after removal from the patient.The patient was reported to be alive with no injury.
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Manufacturer Narrative
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Product analysis summary: a dislodged stent was returned for analysis.The stent delivery system was not returned for analysis.Deformation and stretching was evident to the returned stent.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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An attempt was made to deploy the resolute onyx stent at the lesion at 12atm.No difficulties were noted during deployment.It was reported that after stenting, the delivery system was withdrawn and the stent also came out.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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