An event of asynchronous leaflet motion was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from the field indicated that the physician decided to rotate the valve until normal leaflet function was confirmed and that a non-abbott device (cor-knot) was used to suture the valve to the annulus.Based on the information received, the cause of the reported incident could not be conclusively determined; however, the physician presumed because the cor-knot was used to suture the valve on to the annulus, the annulus might have been more narrowed than being sutured manually thus affecting leaflet movement.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.H6 health effect - clinical code: code 4582 removed h6 health effect - impact code: code 2199 removed.
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