The device was not returned for evaluation.The reported patient effect of cardiac failure is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the 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.
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