It was reported that the procedure was to treat de novo lesion with heavy calcification and heavy tortuosity in the mid-right coronary artery.An attempt was made to advance the 3.5 x 38 mm xience sierra stent delivery system (sds) for direct stenting, however, the sds failed to cross the lesion due to anatomy.During sds removal, resistance with the anatomy was also noted.Dilatation was performed with an unspecified balloon, and the sds was re-inserted but failed to cross the lesion again.Finally, atherectomy was performed with a non-abbott device, and a non-abbott drug-coated balloon (dcb) was used to successfully complete the procedure.There were no adverse patient effects, and no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.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 eifu deviation(s) directly caused or contributed to the reported event.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.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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