Model Number 82086-01 |
Device Problems
Mechanical Jam (2983); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 70% stenosed lesion in the internal carotid artery.A 9tx40mmx136 xact carotid self-expanding stent system (sess) was advanced to the target lesion; however, the thumbwheel became stuck and could not be rotated, causing the sess to become exposed but not flowered or deployed.The stent was completely within the deployment sheath and easily removed with the delivery catheter.There was no adverse patient effect and no clinically significant delay in the procedure.The stent was intentionally released outside of the anatomy without issue.A new, same size xact sess was used to successfully complete the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported activation/deployment failure and the reported mechanical jam were unable to be confirmed.The deployment actuator was rotated with no issues and operates properly.The stent deployed with no anomalies noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As the reported difficulties were unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the distal shaft was restricted in the moderately calcified, mildly tortuous, 70% stenosed anatomy preventing the shaft lumens from moving freely resulting in the reported mechanical jam and the reported activation/deployment failure.Manipulation of the device resulted in the reported stent exposed but not flowered/noted premature activation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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