During a procedure to implant a 14 mm amplatzer septal occluder (aso), the defect had a deficient aortic rim and was balloon sized to 14x12 mm.The 14 mm aso was deployed and no flow was seen around the device and the push/pull maneuver was successfully performed.Upon release, the aso embolized to the pulmonary artery.The aso was surgically removed and the defect was surgically closed.
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The results of this investigation confirmed the amplatzer septal occluder met all dimensional specifications when analyzed at abbott.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 embolization remains unknown.
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