BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 2212612 · Received August 16, 2011

    Report

    Report Number
    2015691-2011-16047
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS RECEIVED BY THE SALES REP. A CORRECTED CUSTOMER EXPERIENCE REPORT, COMPLETED BY THE SURGEON, WAS PROVIDED INDICATING THAT "THERE WERE OTHER REASONS CONTRIBUTING TO THE PATIENT'S DEATH (FIVE DAYS LATER)." (B)(4) = SUTURE LOOP.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NO. 2800 WHICH IS MARKETED IN THE U.S. METHOD: DEVICE NOT RETURNED. THE DHR REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. A COPY OF THE TEE ON CD AND THE OPERATIVE REPORT HAVE BEEN REQUESTED BUT HAVE NOT BEEN PROVIDED. THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IT HAS BEEN LEARNED THAT THE EDWARDS DEVICE WAS REPLACED WITH AN UNKNOWN MODEL MEDTRONIC DEVICE AND THE PATIENT HAS EXPIRED APPROXIMATELY "5 DAYS LATER". DATE OF DEATH HAS NOT BEEN CONFIRMED. CAUSE OF DEATH HAS NOT BEEN PROVIDED. SURGEON INDICATED THAT THE EDWARDS DEVICE HAD NO RELATIONSHIP WITH THE CAUSE OF DEATH. CONCLUSION: SUTURE LOOPS OCCUR WHEN A SUTURE IS CAUGHT ON THE STENT POST OR COMMISSURE AND PREVENTS THE LEAFLETS OF A BIOPROSTHETIC HEART VALVE FROM FUNCTIONING PROPERLY. THIS OCCURS DUE TO IMPROPER TECHNIQUE OR POOR VISUALIZATION OF THE VALVE DURING IMPLANTATION, AND IS NOT A MALFUNCTION OF THE DEVICE. IN MILD CASES, IT MAY GO UNDETECTED AND MAY CAUSE MILD REGURGITATION. IN OTHER CASES, SEVERE REGURGITATION MAY RESULT WHICH MAY BE DETECTED DURING THE PROCEDURE OR AT SOME LATER TIME DURING THE POST-OPERATIVE PERIOD, WHICH MAY REQUIRE REOPERATION. EDWARDS' VALVES HAVE A SPECIALIZED HOLDER DESIGNED TO PREVENT OR MINIMIZE SUTURE LOOPING. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING CAUTION STATEMENT: CAUTION: AVOID LOOPING OR CATCHING A SUTURE AROUND THE OPEN CAGES, FREE STRUTS OR COMMISSURE SUPPORTS OF THE VALVE WHICH WOULD INTERFERE WITH PROPER VALVULAR FUNCTION. THE IFU FURTHER INSTRUCTS THE SURGEON ON HOW TO AVOID SUTURE LOOPING.

    Description of Event or Problem · 1

    REPORTEDLY, A 25MM VALVE WAS EXPLANTED AT IMPLANT. PER THE SURGEON'S REPORT, THE DEVICE WAS EXPLANTED DUE TO A SUTURE LOOP DETECTED AFTER THE PATIENT WAS TAKEN OFF BYPASS. THE EXPLANTED VALVE WAS NOT KEPT AND THE SURGEON HAS INDICATED THAT THERE WAS NO FAULT WITH THE EDWARDS VALVE. IT HAS ALSO BEEN LEARNED THAT THE VALVE WAS REPLACED BY A MEDTRONIC VALVE AND THE PATIENT EXPIRED 5 DAYS LATER DUE TO CAUSES NOT RELATED TO THE EDWARDS DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 10G165

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| R