Additional information: d10, g4, h2, h3, h6 h10.The reported regurgitation could not be confirmed.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.
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