Description of Event or Problem · 1
11/4/85 THE PATIENT UNDERWENT CAB SURGERY AND INSERTION OF A PROSTHETIC MITRAL VALVE, CARPENTER-EDWARDS. ON 6/3/92 THE PATIENT UNDERWENT A HEART CATH. THE IMPRESSION: PREVIOUS MITRAL VALVE REPLACEMENT WITH 4+ MITRAL INSUFFICIENCY, ASSOCIATED PULMONARY HYPERTENSION. ON 6/10/92 THE PATIENT UNDERWENT EXPLANATION OF PREVIOUSLY PLACED PORCINE BIOPROSTHESIS AND INSERTION OF NEW MEDTRONIC MECHANICAL MITRAL PROSTHESIS AND CAB. POST-OP THE PATIENT CONTINUED TO DETERIORATE. THE PATIENT EXPIRED 7/2/92. FINAL DX WIDE OPEN MITRAL INSUFFICIENCY SECONDARY TO PREVIOUSLY PLACED PORCINE VITRAL PROSTHESIS IN THE MITRAL AREADEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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: COMPONENT FAILURE, LEAFLET. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.