The device was not returned for evaluation.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 revealed no other similar complaints reported from this lot.Based on the information provided, the reported core break and stretched coils appear to be due to circumstances of the procedure.It is likely that during advancement into the heavily tortuous carotid artery, the tip coils of the barewire became stretched resulting in the core breaking but remaining in one piece due to the tip coils.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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