Medtronic received information that during the implant of this transcatheter bioprosthetic valve into a patient with a previously implant surgical aortic valve (sav), while attempting to advance the delivery catheter system (dcs) through the previous sav at the annulus, hemodynamic breakdown occurred.The dcs was not able to be advanced.It was reported that the dcs was an indirect cause of the hemodynamic breakdown.It was reported that the patient's blood pressure decreased, and acute aortic regurgitation (ar) occurred.The direct cause of the ar was an unknown guidewire.Ventricular fibrillation also occurred.The heart became intolerant to the exacerbation of ar.As a result, percutaneous cardiopulmonary support was introduced, and cardiopulmonary resuscitation (cpr) was initiated.The recovery of the patient was prioritized, and the valve implant attempt was aborted.Of note, it was reported that prior to the valve implant procedure, the patient's hemodynamics were originally poor.No additional adverse patient effects were reported.
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