BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 2173905 · Received July 24, 2011

    Report

    Report Number
    2015691-2011-15911
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    April 12, 2011
    Report Date
    June 27, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL IS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND IS BEING REPORTED AS SIMILAR TO MODEL 2800, WHICH IS MARKETED WITHIN THE UNITED STATES. METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS AND PARAVALVULAR LEAK. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT UNDERWENT CABG AND AORTIC VALVE REPLACEMENT (AVR) IN 2008. THE PATIENT THEN DEVELOPED AORTIC INSUFFICIENCY FROM A PARAVALVULAR LEAK WITH ACUTE PULMONARY EDEMA DUE TO ENDOCARDITIS OF THE BIOPROSTHESIS. PATIENT WAS ALSO SUFFERING FROM ACUTE RENAL INSUFFICIENCY, SEPSIS AND HEART FAILURE. TREATMENT WITH VANCOMYCINE, GENTAMYCINE AND RIFAMPICINE WAS STARTED. ON (B)(6), THE AORTIC BIOPROSTHESIS WAS REPLACED. UPON REMOVAL, THERE WAS A CLEAR DEFINED CAVITY UNDER THE COMMISSURES BETWEEN BOTH CORONARY CUSPS, THE CAVITY ENDS BLIND. THE VALVE WAS REPLACED POSTOPERATIVELY, THE PATIENT HAD INCREASE OF INFLAMMATORY PARAMETERS AND HEMODYNAMIC INSTABILITY AND EVOLVING SEPSIS WITH MULTIPLE ORGAN FAILURE. THE PATIENT EXPIRED ON (B)(6). UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT RETURN OF THE DEVICE, THE REPORTED EVENT CANNOT BE CONFIRMED. NO FURTHER ACTIONS ARE POSSIBLE AT THIS TIME. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 YEARS, 5 MONTHS (29.67 MONTHS) DUE TO UNKNOWN REASONS. IT WAS REPLACED BY A 3300TFX-25MM (SMALLER DEVICE). NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10. 08E116

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R