As reported by the edwards field clinical specialist, approximately 1 year and 3 months post implant of a 29mm sapien 3 valve inside a non-edwards st.Jude surgical in the mitral position a 2nd sapien 3 ultra valve was implanted due to stenosis.In addition, a 2nd valve was implanted inside the 29mm sapien 3 ultra valve due to poor positioning.The patient was stable and was discharged home.Upon review of medical records, approximately 1 year post procedure, an echo (tte) revealed a 29mm sapien 3 valve in the mitral position within a 33mm st.Jude epic valve.The prosthetic mitral leaflets were thickened with a mean gradient of 19mmhg and likelihood of development of halt versus early recurrent prosthetic degeneration.An intra procedure echo (tee) revealed mitral valve with severe stenosis and no significant mitral regurgitation with thickened prosthetic leaflets and barely mobile and a mean gradient of 18mmhg.
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Update to h6 (component code, type of investigation, investigation findings, investigation conclusions), and h10 to reflect engineering evaluation.This report is 1 of 2 being submitted for this complaint.Referenced mfg.Report no.2015691-2022-09992.The 29mm sapien 3 valve was not returned to edwards as it remains implanted in the patient.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A device history records (dhr) review did not reveal any issues that could have contributed to the reported events.A lot history review was performed and revealed no other reported events related to this event.The commander delivery system with s3/s3u thv ifu was reviewed for guidance and instructions.Potential adverse events include valve stenosis and structural valve deterioration.No ifu or training deficiencies were identified.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 the failure mode is not required at this time.The complaints for leaflet thickened/halt and increased gradients post implantation were confirmed based on medical record.A review of dhr, lot history, and complaint history did not identify any manufacturing non-conformances that would have contributed to the reported event.Additionally, no ifu/training manual inadequacies were identified.During the manufacturing process, all sapien s3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect contributed to the event.Per medical records, 'approximately 1 year post procedure, an echo (tte) revealed a 29mm sapien 3 valve in the mitral position within a 33mm st.Jude epic valve.The prosthetic mitral leaflets were thickened with a mean gradient of 19mmhg and likelihood of development of halt versus early recurrent prosthetic degeneration.An intra procedure echo (tee) revealed mitral valve with severe stenosis and no significant mitral regurgitation with thickened prosthetic leaflets and barely mobile and a mean gradient of 18mmhg.' stenosis with thickened leaflets may be a manifestation of structural valve deterioration (svd).Svd refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.In this case, patient had history of chronic kidney disease, which is known to be a risk factor for developing bioprosthetic tissue calcification.Calcified leaflets may in turn become thickened due to build-up of calcium deposits.Elevated gradients may indicate obstructed flow across the valve.An increase in gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular stenosis.In this case, medical record revealed stenosis with thickened leaflets, which likely contributed to the narrowing of effective valve orifice, leading to increased gradients.In this case, available information suggests that patient factors (chronic kidney disease and leaflet thickening) may have contributed to the complaint event.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 ifu/labeling/training manual inadequacies were identified.Therefore, no product risk assessment no corrective or preventative action is required at this time.
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