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Model Number 26605 |
Device Problems
Difficult or Delayed Positioning (1157); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that the stent was not fully resconstrained.The target lesion was located in a common carotid artery.A 10.0-24 carotid wallstent was advanced for treatment.However, the stent was unable to release.When the stent was about to remove, it was not fully reconstrained.The device was removed carefully and slowly.Another carotid wallstent monorail 10.0-24 was deployed but still the sent was unable to release and it was not fully resconstrained prior to removal.The device was also removed carefully and slowly, and it seems that the device was damaged.The procedure was completed with another of same device.No patient complications were reported and the patient was stable.
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Manufacturer Narrative
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B5.Describe event or problem- updated.
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Event Description
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It was reported that the stent was not fully reconstrained.The target lesion was located in a common carotid artery.A 10.0-24 carotid wallstent was advanced for treatment.However, the stent was unable to release.When the stent was about to remove, it was not fully reconstrained.The device was removed carefully and slowly.Another carotid wallstent monorail 10.0-24 was deployed but still the sent was unable to release and it was not fully reconstrained prior to removal.The device was also removed carefully and slowly, and it seems that the device was damaged.The procedure was completed with another of same device.No patient complications were reported and the patient was stable.It was further reported that it was an 80% stenosed target lesion was located in the non-calcified and mildly tortuous common carotid artery.The stents were deployed by following the normal operation steps.
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Search Alerts/Recalls
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