It was reported that on 12 feb.2024, a 20mm amplatzer septal occluder was selected for an implant using a 9f amplatzer trevisio intravascular delivery system.During the procedure, there was a problem in shape retention, the device was not taking the desired shape for deployment and appeared cobra in shape.Device was removed from the patient prior to released from the delivery cable.No interaction with cardiac structures during deployment and no angulation or kink noticed in the delivery system.It is unknown if the device was replaced.The patient is stable.
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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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.Information from the field indicated that there was no interaction with cardiac structure and no any angulation/kink noticed in the delivery system, and an unknown size for the delivery system was used.Based on the available information, 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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