BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 1961906 · Received January 14, 2011

    Report

    Report Number
    2015691-2011-14677
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    August 13, 2010
    Report Date
    December 15, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: AFTER REPEATED REQUESTS FOR ADDITIONAL INFORMATION AND CLARIFICATION OF THE EVENT, NO INFORMATION HAS BEEN RECEIVED OTHER THAN THE SURGEON HAS INDICATED THE EXPLANT WAS NOT DUE TO A FAULT OF THE DEVICE. THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. NO OTHER INFORMATION HAS BEEN PROVIDED. THE OPERATIVE REPORT HAS BEEN REQUESTED BUT NOT PROVIDED. AT THIS TIME, THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION OR AN ALLEGATION OF A DEVICE MALFUNCTION. WITH THE LIMITED AMOUNT OF INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE REPORTED DEVICE FOR EVALUATION, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    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: NO FURTHER DETAILS WERE PROVIDED. INVESTIGATION IS ON-GOING. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING THAT THE EXPLANT OF THE DEVICE WAS NOT DUE TO A MALFUNCTION OF THE EDWARDS DEVICE.

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS 'REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 08J229

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R