BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 1023487 · Received March 27, 2008

    Report

    Report Number
    2916284-2008-00001
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 26, 2008
    Manufacturer
    WORLD HEART, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 3/21/08, WORLDHEART WAS NOTIFIED THAT A (B) (6) NOVACOR LVAS RECIPIENT HAD PUMP-REPLACEMENT SURGERY. THIS PT HAD A CHRONIC INFECTION (BEGINNING (B) (6) 2007) WITH CHRONIC ANTIBIOTIC THERAPY AND TWO DEBRIDEMENT PROCEDURES. ENDOCARDITIS WAS SUSPECTED AND SURGERY TO REPLACE THE MITRAL VALVE AND PUMP WAS UNDERTAKEN. THE MITRAL VALVE WAS CLEAN, HOWEVER, AND NOT EXCISED. SURGERY REVEALED APPROX ONE LITER OF BLOOD, SOME CLOTTED, AND LIQUID ANTERIOR AND POSTERIOR TO THE DEVICE. IN ADDITION, SURGERY REVEALED A "LEAK IN THE INFLOW CONDUIT AT THE CANNULA TO VALVE MOUNT JUNCTION" WITH A "LINEAR TEAR OF THINNED OUT PTFE MATERIAL" THAT "SEEMED TO BE ASSOCIATED WITH A LOCAL ABSCESS". THE PT SUFFERED "MULTIPLE INFARCTS TO THE RIGHT HEMISPHERE OF THE BRAIN", THOUGHT TO BE RELATED TO THE SURGERY. THE EXPLANTED DEVICE IS BELIEVED TO HAVE BEEN DISPOSED OF AND WILL NOT BE RETURNED TO WORLDHEART. THEREFORE, NO ENGINEERING ANALYSIS OF THE CONDUIT IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM PUMP DRIVE UNIT DSQ WORLD HEART, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R