The information provided to sjm from a literature article titled, "the detailed observation of valve dysfunction of sudden dyspnea 10 years after mitral valve replacement using three-dimensional tee echocardiography," indicted approximately 10 years postoperatively, the patient presented to the hospital with orthopnea and obvious lung congestion.However, no left ventricular hypertrophy was observed and the ejection fraction was favorable on transthoracic echocardiography.One leaflet was immobile and color doppler showed high turbulence.Prosthetic valve stenosis was indicated.Inr was reduced to 1.28.Continuous heparin treatment with drip infusion and emulgent treatment were performed and the symptoms improved.Transesophageal echocardiography revealed one leaflet was immobile and 3d echo revealed there was thrombus-like mass on the leaflet which impeded the leaflet's mobility.Warfarin was increased.Transesophageal echocardiography revealed the leaflet's mobility improved.The patient hemodynamic status was stable and the valve remains implanted.It was reported the physician did not allege the event was caused by the device.
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The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported immobile leaflet resulting in stenosis remains unknown.
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