BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP FLEX

    MDR report key: 21303563 · Received February 4, 2025

    Report

    Report Number
    1220648-2025-25978
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 17, 2025
    Report Date
    February 27, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF HEMOLYSIS HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS ON IMPELLA RP FLEX SUPPORT. THE PATIENT WAS ALREADY ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). HOWEVER , DURING SUPPORT THE PATIENT'S LACTATE DEHYDROGENASE LEVELS WERE RISING. THEREFORE, THE IMPELLA RP FLEX WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48079 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025462199 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention