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.The reported patient effect of dissection is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that the procedure was to treat a moderately tortuous, moderately calcified de novo left circumflex artery.While implanting a 2.5x33mm xience xpedition stent, a dissection was noted.Another xience stent was used to successfully treat the dissection.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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