Estimated date of event.Estimated date of implant.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effect of hypersensitivity is listed in the xience sierra 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat an unspecified artery.A xience sierra stent was implanted without issue.There was no clinically significant delay.Post stent implantation (unspecified date), the patient experienced a suspected nickel allergy.Treatment, if any, was not reported.No additional information was provided.
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