An 18mm amplatzer septal occluder (aso) was implanted successfully in the patient¿s 12mm ostium secundum atrial septal defect.Approximately eight months later, the patient presented to the emergency room with precordial pain.Following an exam, aortic angiogram and left ventriculography, the aso was observed to have embolized to the ascending aorta.Percutaneous removal of the aso was unsuccessful as the device became deformed and was not able to be retracted.Surgical intervention was required to remove the aso.
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(b)(4).The results of this investigation are inconclusive because the aso was not returned for evaluation.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the reported event remains unknown.
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