(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Dates estimated.Udi#: in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record could not be performed as the lot number was not provided.The reported patient effects of angina, dyspnea, fatigue, hypersensitivity, hypertension and nausea are listed in the xience alpine everolimus eluting coronary stent system instructions for use as known patient effects.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 the design, manufacture, or labeling of the device.The additional xience alpine stent referenced is being filed under a separate medwatch report.
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It was reported that two xience alpine stents were implanted on (b)(6) 2018.Ever since, the patient has experienced severe chest pain, nausea, fatigue, shortness of breath, weakness, high blood pressure and has returned to the emergency room (er) twice.No treatment was performed during the er visits.The patient is concerned that she is allergic to the drug coating on the stent.No additional information was provided.
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