(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.The reported patient effects of fever and hypersensitivity are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.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 manufacture, design or labeling.The 3.00 x 33 mm xience alpine referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report.
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It was reported that a 3.00 x 18 mm xience alpine stent and a 3.00 x 33 mm xience alpine stent were implanted on (b)(6) 2017.On (b)(6) 2017 the patient presented at the emergency room with a fever of unknown origin that began on (b)(6) 2017.The patient was hospitalized from (b)(6) 2017.The patient's body temperature during hospitalization ranged between 103.28 degrees 98.78 degrees.Several tests were run and white blood cell (wbc) was low.The patient was treated with antibiotic for 5 days, and other medications; aspirin, bisoprolol, pitavastatin, clopidogrel.The patient still had a fever.On (b)(6) 2017, the patient was transferred to another hospital at their request for treatment.On (b)(6) 2017 the patient was seen in the out-patient department and was still complaining of a fever.On (b)(6) 2017 the patient was seen again in the out-patient department and was no longer complaining of a fever.The physician speculated that the patient's fever may have been caused by the drug eluting from the xience alpine stents and after a month there was no more drug eluting from the stents.No additional information was provided.
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