BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1897161 · Received November 12, 2010

    Report

    Report Number
    2015691-2010-14359
    Event Type
    Death
    Date Received
    November 12, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 14, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. PATIENT EXPIRED 38 DAYS AFTER EXPLANT DUE TO UNKNOWN REASONS. TWO EDWARDS DEVICES REMAIN IMPLANTED IN THE AORTIC AND MITRAL POSITIONS. (B)(4). ADDITIONAL INFORMATION PROVIDED TO THE REGISTRY INDICATES THAT TWO ADDITIONAL TISSUE VALVES -- BOTH NON-EDWARDS DEVICES -- HAD BEEN EXPLANTED. IMPLANT POSITIONS, IMPLANT AND EXPLANT DATES, AND REASON FOR EXPLANT OF THESE DEVICES ARE ALL UNKNOWN. NO FURTHER DETAILS WERE PROVIDED. 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

    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 (B)(4) REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT'S FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX S-10F1451

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| R