The dislodged leaflet was confirmed.The leaflet was returned intact, with no other anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined; however, the damage may have been caused by some external force applied to the valve which overstressed the carbon material.Furthermore, information from the field indicated that the holder was not attached to the valve at the time of parachuting it into place.Please note, per the instructions for use (ifu), artmt600080902 rev.B, "do not use instruments other than the valve holder handle to align and seat the valve, and exercise extreme care to avoid putting stress on the valve orifice or leaflets." step 5 states "parachute the valve into place," at which point step 6 indicates "cut the two retention sutures from the holder/rotator, and gently withdraw the holder/rotator from the valve." furthermore, information from the field indicated the physician believed the dislodged leaflet may have been the result of over-sizing.Per the warnings section of the ifu, "proper valve size selection is crucial.Do not oversize the valve.If the native annulus measurement falls between two sjm regent¿ mechanical heart valve sizes, use the smaller size sjm regent¿ mechanical heart valve.".
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The dislodged leaflet was confirmed.The leaflet was returned intact, with no other anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined; however, the damage may have been caused by some external force applied to the valve which overstressed the carbon material.Furthermore, information from the field indicated that the holder was not attached to the valve at the time of parachuting it into place.
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