Medtronic received information that this patient underwent surgery to replace a previously implanted mitral valve bioprosthesis which had developed paravalvular leak (pvl).During the procedure, an unknown manufacturer's mitral valve was implanted and found to be competent.The patient was weaned off of cardiopulmonary bypass (cpb) and, upon inspection prior to chest closure, bleeding was observed from the posterior side of the heart.The patient was put back on cpb.It was observed that there was atrio-ventricular (av) disruption with blood emanating from the av groove.The previously placed mitral valve was then removed, this 25mm medtronic bioprosthetic valve was placed, and a pericardial patch was used to reconstruct the posterior annulus.Upon attempted weaning from cpb a second time, the right ventricle was not functioning normally.It was reported that this was possibly due to an injured right coronary artery.An additional repair attempt was made with a vein graft and an intra aortic balloon pump was placed.After the multiple repair attempts, it was reported the heart was extremely compromised and the patient passed away during the procedure.There was no evidence to suggest that the medtronic valve or its function contributed to the patient¿s death.It is unknown whether an autopsy was performed.
|