(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 identified no other incidents from this lot.The nav6 instruction for use (ifu) states: the system is indicated for use during percutaneous transluminal angioplasty and stenting procedures in saphenous vein grafts and carotid arteries.It is unknown if the deviation to the ifu contributed to the reported difficulties.The investigation determined the reported difficulties appear to be 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.
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It was reported that during the procedure of the moderately calcified, restenosed, narrow, proximal popliteal artery after device preparation, the emboshield nav6 embolic protective device (epd) device was positioned; however, other unspecified devices met resistance advancing over the barewire and were removed separately from the anatomy.It was decided to remove and replace the epd.Resistance was met pulling the filter into the retrieval catheter, so using slight force, the epd with debris was retrieved and removed from the anatomy.Outside the anatomy, a kink was noted in the barewire.A different emboshield nav6 and barewire were used in the procedure.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.
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