Description of Event or Problem · 1
THIS SIXTY-THREE YEAR OLD PATIENT HAD A HISTORY OF RHEMATIC HEART DISEASE SINCE EIGHT YEARS OF AGE. THE PATIENT WAS STATUS POST BEALL PROSTHETIC MITRAL VALVE REPLACEMENT IN APRIL, 1972. THE PA<TIENT EXPERIENCED ACUTE EMBOLIZATION OF THE PLASTIC VALVE FROM THE BEALL PROSTHESIS ON DECEMBER 19, 1991, WHICH RESULTED IN ACUTE CARDIOGENIC SHOCK, FROM WHICH THE PATIENT DID NOT RECOVER DESPITE AGRESSIVE SURGICAL INTERVENTION, TWO VALVE REPLACEMENTS AND EXPLORATION OF THE VASCULAR TREE FOR THE PROSTHESISINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: END OF LIFE - EXPECTED, EXPECTED WEAR/DETERIORATION, TELEMETRY FAILURE, KNOWN LONG TERM COMPLICATION OF PROCEDURE, DISC. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.