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As reported by implant patient registry through receipt of an implant card, the patient had a 26 mm sapien 3 valve implanted in the aortic position via transfemoral approach.Approximately 1 month post implant, the patient's valve was explanted due to unknown reasons and replaced with a surgical valve.
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As reported by implant patient registry through receipt of an implant card, the patient had a 26 mm sapien 3 valve implanted in the aortic position via transfemoral approach.Approximately 1 month post implant, the patient's valve was explanted due to unknown reasons and replaced with a surgical valve.Upon medical records review, the patient underwent a right transfemoral tavr procedure with a sapien 3 valve. on post-operative day 10 the patient presented to a different medical facility with right femoral groin seroma and infection which led to endocarditis of the tavr valve, mrsa bacteremia and was transfer to the implant facility for evaluation.Upon arrival the patient was in septic shock and it was decided to explant the thv.On pod-23 an avr procedure was performed concomitantly with an mvr, pacemaker removal and cabg x 1 procedures.The hospital course was complicated by cerebellar hemorrhage and ischemic stroke, right femoral mycotic pseudoaneurysm of the previous tavr site, ams, encephalopathy.After discussion with the family the patient was put on comfort care given the worsening neurological state and poor prognosis.On pod-35, the patient was made dnr/dni and was taken off of life support and passed away.
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This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-00145 for the report regarding the patient's demise.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.In addition, the instructions for use (ifu), permanent or transient neurological events including stroke are potential adverse events associated with the tavr procedure and the use of the edwards thv devices.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. according to literature review, and as documented in a clinical technical summary, stroke is recognized in the literature as a well-known complication in a small number of patients undergoing tavr.Risk factors correlating with a number of patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during tavr are undoubtedly multifactorial, the dominant etiology likely being intra-procedure embolic events.A transcranial doppler study during tavr demonstrated that the majority of procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early post-procedure stroke: female sex, ef < 30%, diabetes, age older than 70 years, bypass procedure time> 120 min, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no important differences in the frequency of late strokes between tavr and avr patients.After tavr, there appears to be a more significant proportion of early strokes occurring < 24 h post-procedure, but tavr patients with multiple co morbidities are probably at higher risk of both early and late strokes.In this case, there was no allegation or indication that the reported endocarditis was related to a sterilization failure during the manufacturing process of the valve.Investigation results suggest/indicate the source of the infection was due to groin access site infection with mrsa septicemia.The cause of the stroke post tavr cannot be confirmed, however, it may have been related to the mrsa bacteremia and other patient post procedural patient comorbidities. 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.
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