Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.The subject device is not available for evaluation as it remains implanted in the patient.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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 a patient with an inspiris resilia valve model 11500a25 implanted in the aortic position underwent a valve-in-valve (viv) procedure after an implant duration of 1 month and 5 days (36 days) due to dehiscence leading to pvl.The patient was asymptomatic.Per medical opinion, calcification which did not allow a perfect implantation could have contributed to the pvl.A 29mm sapien 3 valve was implanted within the edwards surgical device with no reported complication for the patient.As reported, the procedure ended successfully.The patient was discharged in good condition few days after the procedure but with presence of negligible residual anterior periprosthetic leak.
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