An event of a dislodged leaflet was reported.The results of the investigation are inconclusive since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use artmt100122074 ver.A, "use only the valve holder/rotator packaged with the sjm regent¿ mechanical heart valve to perform valve rotation.Use of other instruments could result in structural damage.The valve holder/rotator is intended for single use only and should be discarded after surgery." "to avoid structural damage, the valve must be rotated in the fully closed position." "to minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve.".
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On (b)(6) 2019, a 21mm regent valve was selected to be implant.During the procedure, one of the leaflet dislodged to the left ventricle.The valve was removed from the patient and replaced with another 21mm regent valve was implanted.No additional information was provided.
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