It was reported that the procedure was performed to treat a lesion in the heavily tortuous and heavily calcified internal carotid artery.The emboshield nav6 embolic protection device filter was deployed without difficulty.However, while advancing the retrieval catheter, due to the anatomy the retrieval catheter could not reach the filter.The 8f guiding catheter that was already in the body was advanced to the filter then pull backed the barewire until the filter was completely inside the guiding catheter.There was no adverse patient effect or a clinically significant delay in procedure.No additional information was provided.
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Visual and functional analysis was performed on the returned device.There was no damage noted to the filtration element.There was no damage noted to the delivery catheter.The barewire-core was bent proximal to the barewire-step.The barewire-coils were bunched proximal to the barewire-step.The barewire-coils were wavy sporadically from the barewire-step to the distal tip.The retrieval catheter was received with the tray.No damage was noted to the retrieval catheter.The filtration element was loaded into the expandable tip of the retrieval catheter.The filtration element was retrieved with no resistance nor anomalies noted.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 complaints reported from this lot.Based on the information provided, the failure to advance and difficulty removing the retrieval catheter appears to be due to challenging anatomical conditions, which were described as heavily tortuous and heavily calcified.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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