Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis in this case was most likely impacted by the progression of the patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device is not available for evaluation, as it remains implanted in the patient.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Edwards received notification that this patient with a 25mm pericardial aortic valve underwent a valve-in-valve procedure after an implant duration of nine (9) years and two (2) months due to aortic stenosis.A non-edwards transcatheter valve was implanted within the pre-existing edwards device.As reported, this transcatheter non-edwards device dislodged during sheath removal and two (2) months and six (6) days later, a 23mm edwards transcatheter valve was successfully implanted within the non-edwards transcatheter valve using the transfemoral access.The patient was reported to be alive.
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