(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.A review of the lot history record revealed no non-conformances.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.The other supera and absolute pro devices referenced are being filed under separate medwatch mfr reference numbers.(b)(4).
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It was reported that the patient had an allergic reaction about three weeks after an absolute pro self-expanding stent system (sess) and two 5.5x115mm supera sesss were implanted on (b)(6) 2015.There is swelling and itching in various places on the body.Medications have been stopped, and benadryl was recommended by the physician.Severe headaches have recently started, and prednisone was prescribed.The symptoms started to return when prednisone course was terminated, and have been getting worse.No additional information was provided.
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