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.Additionally, a photo was received from the field and it appeared to show the device deformity (cobra shape).However, it could not be confirmed as there was no cobra shape deformity during the returned device analysis.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, or angulation or kink in the delivery system upon deployment and a 12f delivery system was used.The cause of the reported incident could not be conclusively determined.Na.
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