The device was not returned for evaluation.The reported patient effect of hypersensitivity is listed in the xience alpine 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(s), 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.The additional five xience alpine and one xience proa referenced are being filed under separate medwatch report numbers.
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It was reported that on (b)(6) 2018 a 2.75x28mm, 3.0x18mm, 2.5x18mm, and a 3.0x18mm xience alpine stents were deployed without issues.On (b)(6) 2020, a 3.0x23mm and a 4.0x38mm xience alpine stents and a 4.0x12mm xience proa stent were deployed without issues.On (b)(6) 2020, the patient was re-admitted with unspecified health issues.Coronary bypass surgery was going to be performed; however, it was canceled because the patient was diagnosed with a suspicion of kounis syndrome due to an allergic reaction.Explanting the stents is being contemplated.There has been no treatment for the allergic reaction.No additional information was provided.
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