BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 1666349 · Received April 25, 2010

    Report

    Report Number
    2015691-2010-13203
    Event Type
    Death
    Date Received
    April 25, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 24, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED ON THE SAME DAY; (B) (6). THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WAS RECEIVED. 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 REPORTED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. IT WAS LEARNED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF ZERO DAYS. PER THE OPERATIVE REPORT: "HEMOSTATIS WAS OBTAINED. THE STERNUM WAS THEN APPROXIMATED WITH PERISTERNAL WIRES, NUROLON FOR FASCIA AND WHILE THE PATIENT WAS BEING CLOSED, DESPITE MAXIMUM PRESSOR SUPPORT, BOLUSES OF EPINEPHRINE, THE PATIENT COULD NOT SUSTAIN AND WAS PRONOUNCED DEAD IN THE OPERATING ROOM AT 1406."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-09H1775

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death