BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALVE AORTIC EDWARDS PERICARDIAL 2800 23MM

    MDR report key: 1000964 · Received February 21, 2008

    Report

    Report Number
    1000964
    Event Type
    Death
    Date Received
    February 21, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    LWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AORTIC TISSUE VALVE REPLACEMENT LATE LAST YEAR. THE VALVE WAS NOT FUNCTIONING PROPERLY PER SURGEON. THE VALVE WAS MOVING UP AND DOWN, "UNSTABLE." THERE WAS MITRAL REGURGITATION POSSIBLY RELATED TO AV FAILURE. WHEN THE VALVE WAS EXPLANTED IT WAS 1.1, AT THE TIME OF IMPLANT IT MEASURED 1.7. PER SURGEON, THIS SHOULD NOT HAVE OCCURRED. THE PATIENT DEVELOPED ENDOCARDITIS, UNKNOWN IF RELATED TO VALVE FAILURE. AT THE TIME OF EXPLANT, THE VALVE AND SURROUNDING TISSUE WERE INFECTED. THE TISSUE WAS CULTURED AT THIS TIME, BUT NOT THE VALVE. THE TISSUE WAS EXTREMELY FRIABLE AND IT WAS DIFFICULT TO GET A REPAIR AND SUTURE, IMPOSSIBLE TO CONTROL BLEEDING. AFTER SEVERAL ATTEMPTS, THE REPAIRS WERE MADE, BLEEDING CONTROLLED AND THE PATIENT WAS REMOVED FROM BYPASS. THE CHEST WAS PACKED OPEN TO CONTROL BLEEDING. AT THE END OF THE PROCEDURE, JUST PRIOR TO TRANSFER, THE PATIENT BEGAN TO BLEED AGAIN. PACKING WAS REMOVED AND THE CHEST REPACKED. AFTER SEVERAL ATTEMPTS TO STOP BLEEDING, THE PATIENT EXPIRED IN THE O.R.====================== MANUFACTURER RESPONSE FOR AORTIC TISSUE VALVE, VALVE AORTIC EDWARDS PERICARDIAL 2800 23MM:======================PROVIDED RETURN KIT AND ASKED US TO RETURN VALVE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALVE AORTIC EDWARDS PERICARDIAL 2800 23MM HEART VALVE, BOVINE LWR EDWARDS LIFESCIENCES, LLC 2800 23MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| H| R CARDIAC DRUGS| CARDIAC DRUGS