(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, angina is listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that on (b)(6) 2016, a 2.5x12 rx xience alpine drug-eluting stent was implanted for treatment of an unspecified vessel.On (b)(6) 2016, the patient was rehospitalized due to abnormal echocardiogram test results with atrial fibrillation.Unspecified treatment was administered and the final patient outcome is reportedly unknown.No additional information was provided.
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