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 bradycardia/arrhythmia are listed in the xact instructions for use as known potential patients 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 therapy/non-surgical treatment and treatment with medication was related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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