As reported from a clinical study in spain, approximately 24 days post tavr procedure using a 23mm sapien 3 ultra valve via transfemoral approach, the patient presented mitral and bioprosthetic aortic endocarditis.Vegetations were seen in the transesophageal echocardiogram (tee) of the mitral (native valve) and in the prosthetic aortic valve.E.Faecalis bacteria was found in the blood, and the patient presented with a fever and asthenia symptoms.The source of the infection is unknown.The mitral and aortic valves were explanted and replaced with aortic new prosthetic valves.The event was resolved.
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Per the instructions for use (ifu), infections such as septicemia and endocarditis are known potential adverse events associated with the thv procedure.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).The two categories show definite differences in clinical features, microbial patterns, and mortality.Early prosthetic valve endocarditis is usually caused by perioperative bacterial contamination of the valve.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery.If there were ever non-conformances in the sterility or packaging processes, they would most likely manifest in the early post-operative period.Considering this, only reports of prosthetic endocarditis occurring within 60 days of implant, without a known source of infection, would be mdr reportable.According to the literature review, and as documented in a technical summary written by ew, early prosthetic valve endocarditis occurring within 60 days of valve implantation generally reflects contamination arising in the perioperative period.There are many opportunities for organisms to seed a prosthesis perioperatively, most contamination probably occurs intraoperatively.Edwards lifesciences produces and provides sterile tissue bioprosthesis 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' bioprosthesis is remote.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate e.Faecalis bacteria caused or contributed to this event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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