The patient presented 5 years postoperatively with fatigue and shortness of breath.An echocardiogram revealed critical aortic stenosis and an elevated gradient.The valve was explanted due to moderate regurgitation, paravalvular leak, stenosis, valvular deterioration and pannus formation on the cusps.A 21 mm sjm mechanical valve (model and serial number unknown) was implanted.The patient was reported to be stable postoperatively.
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(b)(4).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 record, 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 incident could not be conclusively determined.
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