BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.0

    MDR report key: 20792368 · Received November 27, 2024

    Report

    Report Number
    1220648-2024-24251
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    November 25, 2021
    Report Date
    October 6, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010053
    PMA / PMN Number
    P140003
    Adverse Event
    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

    B3 DATE OF EVENT WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24251. B5 ADDITIONAL FAILURE MODE WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24251. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2024-24251 IN ACCORDANCE WITH UPDATED PROCEDURES. H6 HEALTH EFFECT - CLINICAL CODE 1770 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24251. H6 INVESTIGATION CONCLUSIONS CODE 11 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24251.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT NEEDING AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT DUE TO CARDIOMYOPATHY. DURING IMPELLA PLACEMENT, THE PATIENT EXPERIENCED BLEEDING AT THE INSERTION SITE. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINED ON IMPELLA SUPPORT AND WAS SUCCESSFULLY WEANED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED CEREBROVASCULAR ACCIDENT (CVA) DURING SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359490 IMPELLA 5.0 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.0 2022024926 00813502010053

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention