The device was returned for analysis.The reported activation/deployment failure was unable to be confirmed.The stent implant was exposed 1.3 millimeters from the distal end of the sheath.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.As the reported difficulties were unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the distal shaft was restricted in the anatomy and/or with other devices preventing the shaft lumens from moving freely resulting in the reported activation/deployment failure.Manipulation of the device and/or handling during packing for return analysis likely resulted in the noted exposed stent implant.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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