28 october 2019: additional information received on this date reported that all pieces of the device are confirmed to be removed.The patient was hemodynamically stable throughout the procedure.The user does allege a clinically significant prolonged procedure time.8 october 2019: additional information received on 7 october 2019 reported that the physician had already lowered and cut the stitches.The physician was going to try to open and close the valve with the silicone pencil.However, when moving the device, it broke into two parts.The procedure was completed with a new 21mm masters valve.On (b)(6) 2019, a 19mm regent mechanical heart valve was selected for implant.However, the device failed during implant and was removed.No patient consequences were reported.
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Additional information: d10, h3, h6, h10 ; the reported event of one of the leaflets fracturing and dislodging during rotation was confirmed.One leaflet had dislodged and fractured into multiple pieces.No other damage was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.There was no evidence of material defect in the carbon coating that may have caused or contributed to the fractured leaflet.The cause of the reported event could not be conclusively determined, however it is consistent with damage caused by some external force applied to the leaflet and orifice, which overstressed the carbon material.
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