Per the instructions for use (ifu), infection including septicemia and endocarditis, is a potential adverse event associated with aortic valve replacement.Endocarditis is an infection of a native or prosthetic valve, is treated with antibiotics, and may require valve replacement if antibiotic therapy is not effective.Causes of prosthetic valve endocarditis are well documented in the literature and are typically classified as early (<60 days) or late (>60 days).Early prosthetic valve endocarditis is usually caused by perioperative bacterial contamination of the valve.Edwards lifesciences produces and provides sterile tissue bioprostheses to its customers by following carefully designed robust sterilization processes.These manufacturing processes have been validated and demonstrated to consistently provide a significant safety factor from which microorganisms could not survive.Microbiology and process monitoring is routinely reviewed within quality systems to maintain sterility control.Validated testing has demonstrated that microorganisms could not survive edwards' multi-stage processing with enhanced sterilant or heated glutaraldehyde terminal sterilant solution.These multiple, redundant manufacturing controls ensure the sterility of edwards' valves as provided to customers.Therefore the probability of endocarditis related to edwards' bioprostheses is remote.In this case, there was no allegation or indication of a device malfunction.The source of the infection was not provided.In addition to the procedure itself, patient factors not provided may have contributed to the reported endocarditis approximately 1 month post valve implant.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.This is one of two manufacturer reports being submitted for this patient.
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As reported by our affiliate in (b)(4), a 29mm sapien 3 valve was implanted in the mitral position.Approximately one month after implant, the patient developed endocarditis, and was treated with antibiotics.Patient reported symptoms of dyspnea, and shortness of breath.No bacteria were found in the blood.The source of the infection was not known.It was not known if vegetations were seen on tee.Following the antibiotic therapy, the patient recovered.The valve remained implanted in the patient.
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