BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 22166354 · Received June 9, 2025

    Report

    Report Number
    1220648-2025-29112
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 10, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED. AS THE NECESSARY CLINICAL INFORMATION WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED, THE ROOT CAUSE OF THE ECTOPY AND VENTRICULAR TACHYCARDIA (VT) WAS NOT DETERMINED.

    Description of Event or Problem · 0

    THE COMPLAINANT HAD AN IMPELLA 5.5 PUMP SUPPORT ONGOING FOR A PATIENT ADMITTED IN WITH NEED FOR CORONARY ARTERY BYPASS GRAFT X 4 AND HAD THE IMPELLA 5.5 PUMP PLACED FOR THE SUPPORT OF THE PATIENT. THE PATIENT HAD ECTOPY AND RUNS OF VENTRICULAR TACHYCARDIA (VT) REQUIRING DEFIBRILLATION WITH 200 J. NO CHEST COMPRESSIONS WERE REQUIRED. THE PUMP POSITION WAS ASSESSED. THE LEFT VENTRICLE WAS NOTED TO BE SMALL. THE PUMP REMAINED ON FOR SUPPORT DESPITE THE VT FOR FIVE MORE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633000 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026621510 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention