Medtronic received information that 55 months after implant of this transcatheter bioprosthetic valve, the patient presented to a hospital due to unspecified medical symptoms.A cardiac catheterization revealed increased right ventricular outflow tract pressure, although there was no observed insufficiency or increased gradients.It was reported that a fracture was suspected with another manufacturer¿s stent that had been used for pre-stenting prior to the implant of this device; the timing of the fracture of that device was not known.There was no observation of a fracture of the medtronic device.Three days after the patient presented to the hospital, dilatation of this device was performed with a 22 millimeter (mm) balloon, which resulted in a grade ii stent fracture of the medtronic valve.Two stents from other manufacturers were inserted, and a second valve of this same type was successfully implanted valv e-in-valve, and dilated with a 22 mm balloon, to resolve the patient conditions.No further adverse patient effects were reported and the device remains implanted.
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