BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT

    MDR report key: 1828224 · Received September 8, 2010

    Report

    Report Number
    2015691-2010-14029
    Event Type
    Death
    Date Received
    September 8, 2010
    Report Date
    August 19, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    K781999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 08/20/2010 AND 08/27/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF DEATH REMAINS UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. NO FURTHER DETAILS WERE PROVIDED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT VALVE CONDUIT DYE EDWARDS LIFESCIENCES 4300 R-10A0172

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death