On (b)(6) 2019, a 27mm masters series valve expanded cuff was selected for implant in the mitral position.During positioning, a leaflet fractured.The valve was removed and all pieces were retrieved from the patient.The procedure and bypass were reported as extended a clinically significant time (15 minutes) while exchanging the valve and the patient remained hemodynamically stable throughout.Another 27mm masters valve was implanted successfully and post-operatively, the patient is reported to be stable.
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The reported event of a dislodged leaflet was confirmed.Both leaflets were dislodged from the orifice and returned with the valve.The butterfly apices were also chipped.No other damage was noted.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.The cause of the leaflet dislodgment could not be conclusively determined.Please note, per the instructions for use artmt100122073 ver.A, "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.".
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