Model Number 26605 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter phone: (b)(6).
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Event Description
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It was reported that stent damage occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified carotid dissection.An 8.0-29 carotid wallstent was advanced for treatment.However, a high tension was encountered when advancing the stent, then it got kinked and could not be delivered smoothly.The stent was removed from the patient intact, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.
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Manufacturer Narrative
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Initial reporter phone: (b)(6).Device evaluated by mfr.: carotid wallstent monorail 8.0-29 was received for analysis.A visual examination found the stent of the device to be fully deployed from the device.The deployed stent was not returned for analysis.There were no issues identified with the tip of the device.A visual and tactile inspection identified no kinks or damage to the delivery system.
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Event Description
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It was reported that stent damage occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified carotid dissection.An 8.0-29 carotid wallstent was advanced for treatment.However, a high tension was encountered when advancing the stent, then it got kinked and could not be delivered smoothly.The stent was removed from the patient intact, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.
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Search Alerts/Recalls
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