Medtronic received information that approximately six years and two months following the implant of this transcatheter pulmonary bio prosthetic valve, stenosis was noted, and valve expansion was attempted with an 18 mm and then a 20 mm balloon.Individual strut fractures were noted, and the frame rebounded down with no improvement.Subsequently, the valve was explanted and replaced with a surgical valve approximately six years and seven months post implant.No additional adverse patient effects were reported.
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