It was reported that the procedure was to treat a lesion in the internal carotid artery.A 9x40mm acculink self-expanding stent system (sess) was advanced to the target lesion, and the locking mechanism unlocked; however, the handle would not retract to deploy the stent.The handle was returned to the original position and the device removed from the anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.A non-abbott device was used to complete the procedure.No additional information was provided.
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The device was returned for analysis.The reported activation failure including expansion failures and mechanical jam were able to be confirmed.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.It is possible that the distal shaft was bent in the anatomy preventing the shaft lumens from moving freely, resulting in resistance with the slider and difficulty deploying the stent; however, this could not be confirmed.Additionally, procedural contaminants (dried blood) may have contributed to the confirmed difficulty with the returned unit, as there were no anomalies noted that would contribute to the deployment difficulty.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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