It was reported that the procedure was to treat a heavily calcified, heavily tortuous left circumflex artery.The lesion was pre-dilated with an unspecified device and the 2.5x48mm xience skypoint stent delivery system (sds) was attempted to be advanced; however, failed due to anatomy.Dilatation was performed again and the sds was attempted to be advanced, but still failed to cross due to anatomy.Resistance during removal of the sds was noted with anatomy.Another unspecified stent was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It was reported that the xience skypoint was advanced, but met resistance and was removed, then the same device was reinserted.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodge during retraction back into the guiding catheter.It is unknown if the ifu deviation contributed to the reported event.The investigation determined the reported difficulties appear to be related to the operational context of the procedure, as it is likely the device interacted with the heavily calcified, heavily tortuous lesion during advancement resulting in the reported failure to advance.Further interaction with the challenging anatomy during retraction of the device, as resistance was noted, likely contributed to the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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