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 and/or complaints.The investigation determined that the reported difficulties were likely due to case circumstances.Based on the reported information, the difficulty removing was due to resistance with the anatomy.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 the procedure was performed to treat a lesion in the left carotid artery.An emboshield nav6 embolic protection system (eps) was advanced without issues.Following pre-dilatation, an 8x40mm xact stent system was advanced and the stent was deployed.An attempt to remove the stent delivery system was made; however, resistance with the anatomy was felt.The 6f introducer sheath was advanced over the delivery system and they were removed as a unit.The nav6 eps was removed without issues.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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