The 4-4 mm adoii was received in the postmarket surveillance lab and was decontaminated.The occluder was grossly and microscopically examined, and no anomalies were found.It met dimensional specifications when measured with a caliper.The device was loaded into a test 5f loader, deployed and retracted without difficulty or deformation, under non-physiological conditions.The results of this investigation confirmed the adoii met all functional and dimensional specifications when analyzed at sjm.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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