Description of Event or Problem · 1
I AM REPORTING TO YOU AN INCIDENT OF MEDICAL PRODUCT THAT HAPPENED ON ME RECENTLY. I HAD AN AORTIC VALVE REPLACEMENT SURGERY USING EDWARDS LIFESCIENCES' PRODUCT IN 2007 IN THE HOSPITAL. THE PRODUCT INFORMATION WAS PERICARDIAL HEART VALVE MODEL 2700, SIZE 23 MM. AFTER NINE MONTHS OF THE SURGERY, IT WAS DIAGNOSED THAT THERE IS LEAKAGE ON THE VALVE. THEREFORE, ANOTHER AORTIC VALVE REPLACEMENT SURGERY HAD TO BE PERFORMED TO SAVE MY LIFE IN THE SAME HOSPITAL IN 2008. IT WAS FOUND THAT THE VALVE HAS DAMAGED WITH SEVERAL HOLES ON IT. ALL MY CARDIOTHORACIC SURGEON, CARDIOLOGIST AND INFECTION DISEASE DOCTOR TOLD ME THAT THERE WAS NOT ANY EVIDENCE SHOWN THAT THE INFECTION HAPPENED IN MY BODY TO CAUSE THE VALVE DAMAGE, AND I WAS ALSO TOLD THAT THE LIFE TIME OF THAT TYPE OF AORTIC VALVE SHOULD AT LEAST BE 10 YEARS, UNFORTUNATELY IT LASTED EVEN LESS THAN ONE YEAR. THE PRODUCT WAS SENT BACK TO THE COMPANY FOR INVESTIGATION. THERE WAS AN AGREEMENT BETWEEN THE REPRESENTATIVE OF THE COMPANY IN THE HOSPITAL, AND ME THAT I WOULD BE INFORMED OF THE RESULT WHEN THE INVESTIGATION WAS COMPLETED. AFTER FIVE MONTHS, I HAVEN'T GOT ANY CONTACT OR INFORMATION FROM THE COMPANY ALTHOUGH I HAVE ASKED MANY TIMES TO THE CLINICAL COORDINATOR OF OR CARDIAC IN HOSPITAL, TO PASS THE MESSAGE INQUIRING TO CO'S REP, AND MY WIFE EVEN LEFT CONTACT MESSAGE IN THE VOICE MAIL OF REGULATORY DEPARTMENT OF THE COMPANY. ON 10/01/08, I SENT A FORMAL REQUEST LETTER TO THE COMPANY. ONE MONTH HAS PASSED, I STILL HAVEN'T RECEIVED ANY FEEDBACK. THE WAY THIS COMPANY HANDLES INVESTIGATIONS AND COMPLAINTS IS VERY UNACCEPTABLE AND DANGEROUS. THE PRODUCTS FROM THE COMPANY IMPACT HUMAN LIFE DIRECTLY. AS A CUSTOMER WHO IMPLANTED THEIR PRODUCT, I HAVE THE RIGHT TO KNOW THE QUALITY OF THE PRODUCT, AND THE INVESTIGATION RESULT OF THE DETERIORATION, WHICH SHOULD BE CONDUCTED UNDER THE GMP/SOP REGULATION AND COMPLIANCE OF 21CFR PART 821. DATES OF USE: 2007 - 2008. DIAGNOSIS OR REASON FOR USE: AORTIC VALVE DAMAGED.