It was reported that the procedure was to treat a lesion in the carotid artery.The acculink self expanding stent system was inserted on the wire and during advancement, resistance was noted, so it was backloaded off the wire.The stent system did not enter the patient.Something did not feel right and it was noted that the stent was exposed, so it was not used.There was no adverse patient effect or a clinically significant delay in procedure.A same sized xact stent was implanted to complete the procedure.No additional information was provided.
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The device was returned for analysis.The reported difficult to advance was unable to be confirmed.The reported premature activation was able to be confirmed.Additionally, multiple bends were noted on the shaft of the device.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 there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a coagulation of blood/contrast on the guide wire resulted in the reported difficult to advance.Manipulation of the device likely resulted in the noted multiple bends in the entire length of the shaft and ultimately resulted in the reported premature activation/stent deployment.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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