Description of Event or Problem · 1
ON SEPTEMBER 15, 1992 AN AORTIC MECHANICAL VALVE WAS IMPLANTED, WHEN THE SURGEON CHECKED TO DETERMINE IF THE VALVE WAS FUNCTIONING PROPERLY, AT THIS TIME THE VALVE WOULD NOT OPEN. USING A PLEDGET, AN ATTEMPT WAS MADE TO OPEN THE VALVE AND 1 LEAFLET WAS FRACTURED FROM THE INCREASING PRESSURE. ONE COMPONENT OF THE VALVE LEAFLET WAS SEEN TO FLY OUT OF THE PATIENT AND THE TWO OTHER PORTIONS OF THE LEAFLET WERE IDENTIFIED AND RECOVERED. THE VALVE WAS THEN EXPLANTED AND REPLACED. A POST-OPERATIVE CHEST X-RAY WAS TAKEN AND THERE WAS NO EVIDENCE OF RETAINED VALVE FRAGMENTSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, LEAFLET. CONCLUSION: INVALID DATA. 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.