BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23896600 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49285
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ==> NO PRODUCT WAS RETURNED FOR INVESTIGATION. PERIPHERAL NERVE INJURY: THE CAUSE OF THE CLINICAL SYMPTOM WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT ==> DEVICE LOT: 1911452 DEVICE HISTORY BATCH ==> SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW ==> DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED TO SUPPORT A PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE PATIENT WAS SUCCESSFULLY ESCALATED FROM AN IMPELLA CP TO AN IMPELLA 5.5. AFTER PLACEMENT VIA THE RIGHT AXILLARY ARTERY, THE PATIENT EXPERIENCED INCREASED BLEEDING AT THE GRAFT ANASTOMOSIS SITE AND REPORTED TINGLING IN THE RIGHT ARM. BLEEDING WAS CONTROLLED WITH ADDITIONAL SUTURES AND BLOOD PRODUCTS, AND HEMOSTASIS WAS ACHIEVED. THE PATIENT¿S CONDITION STABILIZED, AND THE DEVICE WAS SUBSEQUENTLY WEANED AND EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319784 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026656810 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention