It was reported that prior to use when opening the packaging of 2.5x38mm xience prime btk stent delivery system (sds), the shaft of the sds was noted to be damaged, kinked and the stent struts were sticking up.The sds was not used.There was no patient involvement.Another xience prime btk sds was used to complete the procedure.There was no report of clinically significant delay in procedure.Returned device analysis noted that the stent was dislodged on the delivery system balloon; however, remained on the delivery system.Additional follow up was made; however, it could not be confirmed that the stent dislodgement was the previously reported stent damage.No additional information was provided.
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The device was returned for analysis.The reported material deformation and deformation due to compressive stress were confirmed.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 investigation was unable to determine a conclusive cause for the reported material deformation, the reported deformation due to compressive stress and noted stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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