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Model Number 26605 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2021 |
Event Type
malfunction
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Event Description
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It was reported that stent positioning problem occurred.The 60-70% stenosed target lesion was located in the mildly tortuous and moderately calcified carotid artery.An 8.0-21 carotid wallstent was advanced to treat the lesion.However, during stent deployment, the stent jumped about 1mm.The procedure was completed with this device.There were no patient complications reported.
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Event Description
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It was reported that stent positioning problem occurred.The 60-70% stenosed target lesion was located in the mildly tortuous and moderately calcified carotid artery.An 8.0-21 carotid wallstent was advanced to treat the lesion.However, during stent deployment, the stent jumped about 1mm.The procedure was completed with this device.There were no patient complications reported.It was further reported that the target lesion was 70-80% stenosed and was severely calcified.It was noted that the stent migrated just after deployment.
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Search Alerts/Recalls
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