The patient was implanted with three xience alpine stents on (b)(6) 2015 and one non-abbott drug eluting stent in the proximal/mid/distal right coronary artery (rca).The next morning the patient started experiencing hives and swollen glands.The hives were due to verapamil which was stopped on (b)(6) 2015.However, the swollen glands continue.Reportedly, the patient had bare metal stents implanted in 2007 with no complications or issues.No additional information was provided.
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(b)(4).There was no reported device malfunction and the product was not returned.The reported patient effect of hypersensitivity, as listed in the xience alpine everolimus eluting coronary stent system instructions for use (ifu) is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacturing, design or labeling.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.
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