It was reported that the procedure was to treat a de novo lesion in the internal carotid artery with 70% stenosis, mild calcification and mild tortuosity.The 8.0x30mm xact carotid stent system was advanced, however, the stent could not be released and only partially deployed.There was no problem with the deployment mechanism.The stent system was removed and another same size xact stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
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The device was returned for analysis.The reported activation failure was unable 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.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 mildly calcified, mildly tortuous and 70% stenosed anatomy preventing the shaft lumens from moving freely resulting in the reported activation/deployment failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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