The patient's secundum atrial septal defect measured 13.5mm in diameter with a total septal length of 45mm.The stop-flow stretch diameter by echocardiogram and cine was 19-20mm in diameter.Initially, the atrial septal defect was closed using an 18mm amplatzer septal occluder (aso) after the push-pull technique demonstrated device stability; however, upon release the aso embolized into the left atrium and then into the left ventricle.The aso could not be retrieved through the 10f so it was exchanged for a 12f sheath which was used to successfully remove the device.The septal defect was found to be larger than previously anticipated and a 30mm aso was implanted successfully.
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The 18mm aso was returned to sjm and decontaminated.The aso was grossly and microscopically examined, and no anomalies were found.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation confirmed the amplatzer septal occluder met all functional and dimensional specifications when analyzed at sjm.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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