Medtronic received information that during the implant of this transcatheter pulmonary bioprosthetic valve, the inflation of the inner balloon worked adequately, however, during inflation of the outer balloon there was no pressure build up over 2 atm (requires 3 atm).The inflation of the outer balloon was very slow but finally reached an adequate diameter of the valve.After retrieval of the system, a longitudinal tear of the balloon was observed.A covered stent was already in place.No adverse patient effects were reported.
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