Model Number 26605 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.An 8.0-29 carotid monorail stent was advanced for treatment.However, upon reaching the lesion, it was found that the stent was damaged.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr.: a carotid device was received for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent deployed from the delivery system.The stent was noted to be damaged.
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Event Description
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It was reported that stent damage occurred.An 8.0-29 carotid monorail stent was advanced for treatment.However, upon reaching the lesion, it was found that the stent was damaged.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.
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Search Alerts/Recalls
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