BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 14655235 · Received June 10, 2022

    Report

    Report Number
    1220648-2022-01472
    Event Type
    Death
    Date Received
    June 10, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 10, 2022
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502011531
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, INVESTIGATION OF DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RETURNED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A (B)(6)FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK FOR HEMODYNAMIC SUPPORT USING THE IMPELLA 5.5 DEVICE. AFTER REPOSITIONING THE DEVICE, THE PATIENT EXHIBITED BLEEDING FROM THE IMPELLA INSERTION SITE AND BLOOD FOUND POOLING AROUND THE HEART AND LUNGS. FURTHER INSPECTION FOUND THE GRAFT HAD BECOME DETACHED FROM THE AORTA. THE PATIENT EXPIRED AFTER FAILED ATTEMPTS TO INTERVENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726570 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 WITH SMARTASSIST SET, US 2022112962 813502011531

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death