Model Number 26605 |
Device Problems
Break (1069); Positioning Failure (1158); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.The patient presented with right common carotid artery entrapment and underwent stenting.A 10.0-37 carotid wallstent was advanced for treatment.However, during introduction, resistance was encountered.After reaching the target lesion, it was found that the outer sheath was fractured and the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: carotid wallstent monorail 10.0-37 was received for analysis.The device was received with the stent fully constrained in the correct position on the delivery system.The investigator successfully deployed the stent without issue.No damage was noted to the deployed stent.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no shaft separation or damage along the length of the device.
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Event Description
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It was reported that shaft break occurred.The patient presented with right common carotid artery entrapment and underwent stenting.A 10.0-37 carotid wallstent was advanced for treatment.However, during introduction, resistance was encountered.After reaching the target lesion, it was found that the outer sheath was fractured and the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
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Search Alerts/Recalls
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