An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.It was indicated that there was no anatomical interference, there was no angulation or kink in the delivery system upon deployment, and a 7f delivery sheath was used.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.A fluoroscopy cineogram is shown with one aso device already deployed within the inter-atrial septum with traction being applied to the right atrium disc, while a second device is being deployed from another delivery sheath.The second device being deployed shows tendency to form a cobra deformation, while the first device already deployed within the inter-atrial septum shows a normal configuration with the right atrial disc bulging due to traction.The cause of the reported incident could not be conclusively determined.However, per the instructions for use, the recommended the sheath size delivery system for use with a 8 mm amplatzer septal occluder is an 6f, and use of a larger than recommended sheath could have contributed to the device deformation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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