It was reported that on (b)(6) 2022, a 22mm sjm regent heart valve was chosen for implant.During the procedure there was an attempt to rotate the device but there was resistance felt.Rotation was possible after sewing in the intra-annular position but was not possible after sewing in the supra-annular position.After suturing regent in the intra-annular position, the leaflet touched the subvalvular tissue and was removed due to poor opening.Therefore the leaflet was sutured in the supra-annular position to prevent contact with the subvalvular tissue.Since there was still a part that touched the subvalvular tissue, the device was rotated, but it did not turn at all, so force was applied and one leaflet came off as it is.The leaflet fell off as one intact piece and was recovered from the patient.There was an attempt to reinsert the dislodged leaflet but it was not successful.It was noted that the holder handle was fully inserted into the orifice at a 90 degree angle in accordance with the information for use.A non-abbott (18mm ap360 series) device was used to complete the procedure.There were no adverse patient effects.The patient is stable.There was no clinically significant delay in procedure and no adverse patient effects.
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The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged from the orifice and returned with the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that an attempt was made to rotate the valve even though resistance was felt, which could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note, per the instructions for use, "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."g1: manufacturing site updated to #3007113487.
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