BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 17743465 · Received September 14, 2023

    Report

    Report Number
    1220648-2023-03152
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    October 20, 2021
    Report Date
    September 14, 2023
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011531
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE REPORTED THROMBUS AND PUMP STOP WAS COMPLETED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION AND NO DEVICE RETURN, THE ROOT CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS. THE FAILURE MODES WILL BE MONITORED AND TRENDED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A 48-YEAR-OLD MALE PATIENT IMPLANTED WITH THE IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT HAD THE PUMP INGEST A CLOT INTO MOTOR RESULTING IN A PUMP MALFUNCTION. THE PUMP WAS SUBSEQUENTLY REPLACED. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO REPORTS OF HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252398 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2022119320 00813502011531

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention