The device was not returned for analysis.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 from this lot.It is possible that as the stent was being deployed interaction with the anatomy resulted in preventing the shaft lumens from moving freely resulting in the stent to jump in a spring like release; thus resulting in the reported malposition of device (stent jumped forward and did not cover the entire lesion) however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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