It was reported via the implant patient registry that a 23mm 11500a aortic valve, implanted for four (4) months, was explanted due to dehiscence, mod-severe perivalvular regurgitation.The explanted valve was replaced with another 23mm 11500a valve.Per the medical records, the patient presented with chest pain.Echocardiograms concerning for valve dehiscence.The patient underwent redo avr and patch repair of the aorto mitral curtain.There was dehiscence of the right and non coronary aortic cusps.The new valve did not impinge on the coronary ostia.The patient was then transferred to the icu in stable condition.On pod #7, the patient was discharged home in stable condition.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.
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Additional manufacturer narrative: the subject device is not available for evaluation, as it was discarded on-site.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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The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.Valve dehiscence is not a malfunction of the device.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.
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