BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP

    MDR report key: 20238993 · Received September 17, 2024

    Report

    Report Number
    1220648-2024-18140
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    July 20, 2021
    Report Date
    September 17, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    04260113630273
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. IMPELLA RP SYSTEM WITH THE AUTOMATED IMPELLA CONTROLLER INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: SECTION: USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER ¿UNRESOLVED PURGE PRESSURE HIGH ALARM IF NOT RESOLVED BY THE RECOMMENDATIONS PROVIDED, HIGH PURGE PRESSURE¿WHICH TRIGGERS THE ¿PURGE PRESSURE HIGH¿ ALARM MESSAGE¿COULD BE AN INDICATION OF A KINK IN THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER. IN THIS CASE, THE MOTOR IS NO LONGER BEING PURGED AND MAY EVENTUALLY STOP. MONITOR MOTOR CURRENT AND CONSIDER REPLACING THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER WHENEVER A RISE IN MOTOR CURRENT IS SEEN.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT, OF UNKNOWN RACE OR ETHNICITY, WITH RECURRENT RIGHT HEART FAILURE WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT AS A BRIDGE TO LONG TERM THERAPY. IT WAS REPORTED DURING IMPELLA RP SUPPORT, THE PUMP HAD LOWER THAN EXPECTED FLOWS WITH ALARMS FOR SUCTION AND HIGH PURGE PRESSURE. TISSUE PLASMINOGEN ACTIVATOR WAS ADDED TO THE PURGE SOLUTION AND PURGE FLOW WAS RESTORED, AND THE PUMP WAS ABLE TO RUN AT P6 WITH FLOWS OF 3.0 L/MIN. THE PATIENT WAS SUCCESSFULLY ESCALATED TO EXTRACORPOREAL MEMBRANE OXYGENATION FOR INCREASED SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740526 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP EU 2022054251 04260113630273

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male