It was reported that the procedure was performed to treat a moderately tortuous and moderately calcified lesion in the ostial circumflex artery.An attempt to deploy the 2.75x23mm xience alpine stent was made; however, the stent did not fully deploy.Only the proximal and distal struts opened, giving the ¿dog bone¿ image.Several attempts were made to post-dilate the stent with an unspecified non-compliant (nc) balloon, but were unsuccessful.The decision was made to implant a non-abbott stent in the xience alpine to fully appose it to the vessel wall and successfully complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
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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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficult or delayed activation.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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