BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP

    MDR report key: 20575570 · Received October 30, 2024

    Report

    Report Number
    1220648-2024-21621
    Event Type
    Death
    Date Received
    October 30, 2024
    Date of Event
    October 31, 2022
    Report Date
    October 30, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    04260113630273
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THE REPORTED ISSUE HAS BEEN COMPLETED. NO DATA LOGS WERE SENT. VISUAL INSPECTION OF THE RETURNED PUMP REVEALED THE PRESENCE OF BIOMATERIAL ON AND AROUND THE IMPELLA AS WELL AS WITHIN THE PURGE GAP. NO OTHER ABNORMALITIES WERE FOUND. THEREFORE, IT WAS DETERMINED THAT THE CAUSE OF THE HIGH PURGE PRESSURE WAS BIOMATERIAL OCCLUDING THE PURGE GAP. THE LACK OF HEPARIN IN THE PURGE MOST LIKELY LED TO THE BIOMATERIAL BUILDUP. AS NOTED IN THE IMPELLA IFU: IMPELLA RP WITH SMARTASSIST SYSTEM 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 WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. COMPLAINANT REPORTED THE BIPELLA RAN IN THE HOSPITAL WITHOUT HEPARIN. THIS LED TO THE RP PUMP SHOWING THE ERROR MESSAGE PURGE FLOW LOW ALARM. SWITCHED TO NABIC AS PURGE SOLUTION. PF INCREASED AGAIN. DUE TO THE MULTIPLE ORGAN FAILURE, THE PHYSICIANS AND FAMILY DECIDED TO WITHDRAW FROM THERAPY. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983511 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP 2023252915 04260113630273

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Death