The device was returned for analysis.The reported break was confirmed by way of the shaft.The reported deployment issue was unable to be tested.There was additional noted bend at the distal sheath likely due to case circumstances.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 incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the distal shaft was restricted in the anatomy prevented the shaft lumens from moving freely to deploy the stent and as such if the anatomy was challenging may have caused the shaft to separate from the proximal end of the guide wire exit port at the bond; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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