BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 2.5

    MDR report key: 2802549 · Received September 19, 2012

    Report

    Report Number
    2802549
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    September 2, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ABIOMED
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE SURGEON USED THE WIRE THROUGH THE DIAGNOSTIC CATHETER TO EXCHANGE FOR THE IMPELLA DEVICE. THE IMPELLA DEVICE WAS ADVANCED ACROSS THE AORTIC VALVE AND INTO THE LEFT VENTRICLE. LOCATION WAS CONFIRMED BY POST-IMPELLA PUMP MODULE AS WELL AS BY FLUOROSCOPY. THE IMPELLA DEVICE WAS FLUSHED AND INITIATED. INITIAL IMPELLA PUMP FLOW WAS NOTED TO BE AS HIGH AS 1.6 TO 1.8. HOWEVER, THE IMPELLA DEVICE WAS NOTED TO RAPIDLY DECLINE IN ITS AUGMENTED FLOW TO 0.8 TO 0.9. THE IMPELLA DEVICE WAS FLUSHED ONCE AGAIN. MULTIPLE REPOSITIONING OF THE IMPELLA DEVICE WAS PERFORMED. ECHOCARDIOGRAM WAS PERFORMED WITH LIMITED VIEWS TO CONFIRM APPROPRIATE PLACEMENT OF THE IMPELLA DEVICE. THE PATIENT WAS MONITORED CLOSELY WITH IMPELLA DEVICE RUNNING. THE PATIENT WAS NOTED TO HAVE STABLE PULMONARY ARTERY PRESSURES AS WELL AS OXYGEN SATURATIONS. IMPELLA DEVICE WAS NOTED TO HAVE A DECLINE IN AUGMENTED OUTPUT AGAIN TO 0.8 L PER MINUTE. DECISION WAS THEN MADE TO DISCONTINUE THE IMPELLA DEVICE. TO REVERSE THE HEPARIN PREVIOUSLY GIVEN, PROTAMINE WAS ADMINISTERED. THE IMPELLA DEVICE WAS THEN REMOVED WITHOUT DIFFICULTY. HEMOSTASIS WAS OBTAINED WITH THE USE OF MANUAL PRESSURE. AFTER APPROXIMATELY 40 MINUTES OF MANUAL COMPRESSION, THE PATIENT WAS NOTED TO HAVE RESIDUAL HEMATOMA AND EXCELLENT HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPELLA 2.5 PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM ABIOMED 2.5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR