It was reported that on (b)(6) 2023, a 21mm sjm regent mechanical heart valve was selected for an implant.During the procedure, while lowering the valve, one of the valve leaflets dislodged as one piece.After manipulating with forceps/surgical clamp, the leaflet got fractured.The pieces were recovered from the patient.The device was replaced with a new 21mm sjm regent mechanical heart valve, that was successfully implanted.The patient is stable.
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An event of the valve leaflet dislodged while lowering the valve was reported.The investigation confirmed that the sewing cuff was intact and contained blood/body fluids and sutures.The piece of the fractured dislodged leaflet was not received.No other damage was noted to the dislodged leaflet.One image received from the field appeared to show the factured and dislodged leaflet.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 incident could not be conclusively determined.However, field indicated that after manipulating with forceps/surgical clamp, the leaflet got fractured.
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