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Patient 1
A USER INDICATED ON A MEDICAL DEVICE TRACKING FORM THAT A PATIENT WHO WAS BEING SUPPORTED BY A LEFT VENTRICULAR ASSIST DEVICE (LVAD) HAD DIED OF A MAJOR THROMBOEMBOLIC EVENT. THE TRACKING FORM ALSO INDICATED THAT THE DEVICE CAUSED THE PATIENT'S DEATH. FOLLOW-UP CONVERSATIONS WITH PERSONNEL AT THE HOSPITAL DID NOT REVEAL ANY INDICATIONS THAT THE DEVICE HAD MALFUNCTIONED WHILE BEING USED. A LARGE AMOUNT OF CLOT WAS NOTED IN THE VAD AT AUTOPSY, BUT NO INFORMATION IS AVAILABLE TO INDICATE WHETHER THE CLOT WAS PRESENT PRIOR TO THE PATIENT'S DEATH OR FORMED POST-MORTEM. THE DEVICE WAS DISCARDED BY THE HOSPITAL, MAKING IT UNAVAILABLE FOR EVALUATION BY THORATEC. THROMBOEMBOLISM IS A KNOWN RISK FOR ANY TYPE OF CIRCULATORY SUPPORT DEVICE. THE CLINICAL RESULTS SECTION OF THE APPROVED LABELING FOR THE THORATEC VAD NOTES THAT 28% OF PATIENTS IN THE BRIDGE TO TRANSPLANT CLINICAL STUDY AND 38% OF PATIENTS IN THE POST-CARDIOTOMY RECOVERY STUDY SHOWED SOME EVIDENCE OF THROMBOEMBOLISM. THEREFORE, THE REPORTED INCIDENT IS CONSISTENT WITH THE LABELED RISKS OF THE DEVICE.