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.The reported patient effects of transient ischemic attack (tia) and weakness are listed in the xact instructions for use as known potential adverse effects associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The additional hospitalization was related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
It was reported that the xact stent was successfully implanted in the internal carotid artery and the filter was successfully used and removed.There was a lesion distal to the stent that the physician decided not to treat as it was more narrow and the flow was fine.Later, while the patient was eating lunch, they began to experience symptoms of a trans-ischemic attack (tia) with weakness on the right side.A ct scan was performed but no other treatment was performed and the symptoms were improving.The patient was moved to the intensive care unit.The symptoms totally resolved within 24 hours.The physician noted that it was likely not due to the stent.No additional information was provided.
|