THORATEC HEARTMATE 3 LVAD IMPLANT KIT

Description of Event or Problem

AFTER INITIAL IMPLANT OF HEARTMATE 3 DEVICE, IT WAS DISCOVERED THAT THE PUMP WAS NOT CORRECTLY LOCKING INTO THE APICAL SEWING RING. THE PUMP HEAD APPEARED TO BE LOOSE DESPITE BEING FULLY LATCHED ON AND IT WOULD EASILY TWIST AROUND WHILE FULLY LATCHED ALONG ITS AXIS WHILE ATTACHED TO THE SEWING RING. BOTH THE OUTFLOW GRAFT AND INFLOW SIDE SEEMED TO BE DEFECTIVE, AND WOULD NOT SECURELY TIGHTEN DOWN AS INTENDED. THIS CAUSED THE OUTFLOW GRAFT TO BECOME DISCONNECTED DURING NORMAL HANDLING, WITH SIGNIFICANT BLEEDING AROUND THE CANNULA. THE DEVICE WAS REMOVED, THE PATIENT HAD TO BE PLACED BACK ON BYPASS, AND A NEW HEARTMATE 3 DEVICE WAS OPENED AND IMPLANTED.