It was reported that on (b)(6) 2022, a 21mm regent aortic mechanical heart valve was selected for an implant.During the procedure, when testing, the valve leaflets were found to be jammed.The valve leaflets could not be opened and closed effectively.The valve was removed from the patient and was replaced with a new 21mm regent aortic mechanical heart valve that was successfully implanted to complete the procedure.The patient remained hemodynamically stable throughout the procedure.No patient consequences were reported.
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The reported event of valve leaflets not opening and closing normally could not be confirmed.No anomalies were found with the valve leaflets, 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.Based on the information received, the cause of the reported incident could not be conclusively determined.
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