BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROVIS-INJECTOR

    MDR report key: 1976447 · Received January 27, 2011

    Report

    Report Number
    1976447
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 21, 2011
    Manufacturer
    MEDRAD, INC
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS AN (B)(6) FEMALE WHO ON (B)(6), 2011 UNDERWENT A TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANTATION. DURING THE PROCEDURE AN AIR EMBOLUS WAS NOTED IN THE AORTA. PT IMMEDIATELY EXPERIENCED A CARDIAC ARREST REQUIRING EMERGENT CARDIOPULMONARY RESUSCITATION. A HEAD CT SCAN FOLLOWING THIS EVENT CONFIRMED SIGNIFICANT BRAIN INJURY WITH HERNIATION. HYPERBARIC AND HYPERTHERMIA THERAPY WAS INITIATED. AFTER FURTHER NEUROLOGICAL EVALUATION, THE PT WAS DEEMED TO HAVE IRREVERSIBLE BRAIN INJURY. CARE WAS WITHDRAWN PER FAMILY'S REQUEST. PT EXPIRED ON (B)(6), 2011. ON THE EVENING OF (B)(6), 2011, MEDRAD SERVICE TECHNICIAN (B)(6) INSPECTED THE POWER INJECTOR AND ALSO IN ATTENDANCE WAS (B)(6) (HUP CLINICAL ENGINEERING TECHNICIAN). PER MEDRAD SERVICE REPORT, NO MECHANICAL DYSFUNCTION WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVIS-INJECTOR POWER INJECTOR DXT MEDRAD, INC PPD-110 60 507

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| L