It was reported that on (b)(6) 2023, a 21mm sjm regent heart valve with flex cuff was chosen for implant during an aortic valve replacement.Once the valve was placed, it was observed that one of the leaflets did not open completely due to interference from the myocardium.The holder handle was fully inserted into the orifice at a 90 degree angle.There was some resistance felt when rotating.The valve was in the semi-open position during rotation.On second attempt when the valve was rotated with the valve rotator, there was resistance again, and one of the leaflets dislodged as one piece.The piece was recovered from the patient.The valve was removed and replaced with a 19mm sjm regent heart valve with flex cuff.The patient remained hemodynamically stable throughout the procedure.There were no adverse patient effects reported.The patient status was reported as stable.
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An event of one of the leaflets not opening completely due to interference from the myocardium and leaflet let dislodgement was reported.The investigation at abbott confirmed that one leaflet was dislodged from the orifice.The recessed pivot was received fractured and the butterfly recessed was chipped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.One image from field appeared to show mechanical valve having one leaflet dislodged and placed on the side in a jar.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.The damage noted to the valve may have been caused by some external force applied to the valve which overstressed the carbon material.It was reported that the valve was in the semi-open position during rotation and there was some resistance felt when rotating.Please note that per the instructions for use, "valve rotation: using the valve holder/rotator and the flexible valve holder handle model 905-hh, or the rigid valve holder handle model 905-rhh, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation." and "caution: to avoid structural damage, the aortic valve must be rotated in the fully closed position.".
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