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Model Number 26605 |
Device Problems
Mechanical Problem (1384); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that stent damage and reconstraining difficulties were encountered.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified carotid artery.An 8.0-29 carotid wallstent was advanced for treatment.However, during the procedure, it was found that the tip of the stent strut was lifted.The physician tried to remove the device, but it was not fully reconstrained.It was noted that only 10% around the tip of the stent remained unconstrained, so the device could still be removed.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: a carotid device was received for analysis, with stent detached from device, the following attributes were examined during 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 already deployed from the delivery system.No issues noted with the deployed stent.This concludes the product analysis.
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Event Description
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It was reported that stent damage and reconstraining difficulties were encountered.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified carotid artery.An 8.0-29 carotid wallstent was advanced for treatment.However, during the procedure, it was found that the tip of the stent strut was lifted.The physician tried to remove the device, but it was not fully reconstrained.It was noted that only 10% around the tip of the stent remained unconstrained, so the device could still be removed.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient was stable.
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Search Alerts/Recalls
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