It was reported that the procedure was to treat a moderately calcified, moderately tortuous internal carotid artery that is 75% stenosed.The emboshield nav6 embolic protection system (eps) as attempted to be advanced across the lesion; however the barewire stopped giving any tactile feedback and stop advancing.Therefore, the eps was attempted to be removed; however, the eps barewire stretched (tip and coils) and separated near the groin.The tip of the wire was snared out and new emboshield nav6 was used to successfully complete the procedure.There were no adverse patient sequela and no clinically significant delay in the procedure.
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Visual analysis was performed on the returned device.The reported, stretching and tip separation was confirmed.The difficulty advancing and lack of tactile feedback was not confirmed due to the condition of the returned unit.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 similar complaints reported from this lot.The investigation determined that the reported inadequate tactile feedback, difficulty advancing, stretched tip coils, and material separation resulting in unexpected medical intervention to snare the separated portion of the wire were likely related to procedural circumstances.Based on the reported information, it is likely that during the attempt to advance the barewire into the 75% stenosed lesion, the tip of the barewire became lodged/stuck and/or prolapsed within the artery resulting in stretching of the tip coils and ultimately separation during removal.The reported unexpected medical intervention to remove the separated tip was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
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