The information in a literature article indicated the pt underwent aortic valve replacement with a 23 mm sjm masters series valve (medwatch report# 2648612-2014-00025) due to persistent left atrioventricular regurgitation.Inr was maintained and approximately one month postoperatively, the pt presented with dyspnea and the 23 mm valve showed functional deterioration and was diagnosed to be thrombosed.Thrombolytic therapy with urokinase was performed.One month after the emergency thrombectomy, the pt presented with an elevated heart rate and tachypnea.The valve was found to be thrombosed again.The 23 mm valve was explanted and this smaller 21 mm sjm masters series valve was implanted.Ten days following the re-do valve replacement, the pt presented again with dyspnea and intensified peripheral coldness.Thrombolytic therapy was unsuccessful and circulation was unstable.The 21 mm valve was explanted and replaced with a 22 mm valve from another manufacturer.According to the literature article, the hyper-eosinophilia was strongly suspected to be the cause of the repeated valve thrombosis.The antibiotics were suspected to be the cause of the hyper-eosinophilia.Therefore, the administration of the antibiotics was stopped and the eosinophil count was gradually normalized and the pt was discharged in good condition.It was reported the physician alleged this event was not caused by the valve.Kid t., et al, "repeated obstructive prosthetic valve thrombosis suspected to be associated with hyper-eosinophilic syndrome in complete atrioventricular septal defect," pediatric cardiology and cardiac surgery , vol.30 no.2 (200-204).
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The results of the investigation ar 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 thrombus was suspected to be caused by hypereosinophilia.The physician did not allege the event was caused by the device.
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