The device was not returned for analysis.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.The reported patient effects of embolism and tia- transient ischemic attack is listed in the x-act carotid stent system instructions for use as adverse events potentially associated with carotid stents and embolic protection systems.The investigation determined the reported difficult to advance appears to be related to circumstances of the procedure as it is likely that resistance was met with the calcified anatomy resulting in the reported difficulty to advance.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat the left internal carotid artery.An emboshield nav 6 embolic protection system was first deployed without reported issue.The xact carotid stent system was attempted but could not cross the lesion due to the calcification.It was taken out and pre-dilatation was performed with a viatrac balloon dilatation catheter (bdc) without reported issue.The same xact stent delivery system was advanced and was deployed.The status of the stent is known to be patent.At this point, angiogram was performed and when the contrast was injected, air bubbles were seen in the vessel.The patient suffered a transient ischemic attack (tia) and could not speak and had decreased strength with her right hand.The emboshield nav6 filter was removed.After approximately 5-10 minutes, the symptoms resolved.No treatment was reported.A computed tomography (ct) scan was performed after leaving the cath lab.The patient had hospitalization but it was originally planned.The next day the patient's symptoms were back to baseline.There was no significant delay in the procedure.No additional information was provided.
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