Model Number 26605 |
Device Problems
Positioning Failure (1158); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2023 |
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 foreign material was noted on the device.The 90% stenosed target lesion was located in the non-tortuous and non-calcified internal carotid artery.A 10.0-31 carotid wallstent was advanced for treatment.However, after the device reached the lesion, there was resistance in pushing out the stent.Concerned that the stent might get deformed inside the patient, the device was therefore withdrawn.After the device was removed, a foreign body protruding from the connection point of the delivery shaft and sheath was found.The procedure was completed with a different device.There were no patient complications reported, and patient condition was stable.
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Manufacturer Narrative
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(e1) initial reporter phone: (b)(6).Device evaluated by mfr.Carotid wallstent monorail was received for analysis.A visual and tactile examination identified a complete separation of the outer sheath of the device located approximately 30mm distal of the main t-valve.Accordion damage was also noted beginning at the sheath separation and extending proximally to the main t-valve.This type of damage is consistent with excessive force being applied to the device when attempting deployment.The device was returned with the stent in the correct position on the delivery system.The investigator was unable to deploy the stent due to a separation of the outer sheath of the device.No evidence of foreign material was identified on or inside the device.
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Event Description
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It was reported that foreign material was noted on the device.The 90% stenosed target lesion was located in the non-tortuous and non-calcified internal carotid artery.A 10.0-31 carotid wallstent was advanced for treatment.However, after the device reached the lesion, there was resistance in pushing out the stent.Concerned that the stent might get deformed inside the patient, the device was therefore withdrawn.After the device was removed, a foreign body protruding from the connection point of the delivery shaft and sheath was found.The procedure was completed with a different device.There were no patient complications reported, and patient condition was stable.
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Search Alerts/Recalls
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