BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 20540628 · Received October 26, 2024

    Report

    Report Number
    1220648-2024-21242
    Event Type
    Death
    Date Received
    October 26, 2024
    Date of Event
    February 17, 2023
    Report Date
    October 8, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011609
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Additional Manufacturer Narrative · 0

    B1 ADVERSE EVENT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-21242. B2 DEATH AND DATE OF DEATH WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-21242. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2024-21242 IN ACCORDANCE WITH UPDATED PROCEDURES. H1 TYPE OF REPORTS WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-21242. H6 HEALTH EFFECT - IMPACT CODE 1802 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-21242 H11 INVESTIGATION CONCLUSIONS 11 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-21242.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE DEVICE EXHIBITED SUCTION ISSUES INDICATING LOW FLOW. THE RESOLUTION FOR THIS ISSUE IS UNKNOWN. THE PATIENT OUTCOME AT EXPLANT NOTED THAT THE PATIENT EXPIRED. NO FURTHER INFORMATION IS AVAILABLE. O MEDICAL SAFETY REVIEW OF THE EVENT NOTED USE OF THE DEVICE CANNOT CONCLUSIVELY BE ASSOCIATED WITH THE OUTCOME (PATIENT'S DEMISE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092574 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2023231681 00813502011609

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death