An event of device deformity did not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Reportedly, 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.Based on the information reviewed and returned device analysis, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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