BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.0

    MDR report key: 20730254 · Received November 19, 2024

    Report

    Report Number
    1220648-2024-23597
    Event Type
    Death
    Date Received
    November 19, 2024
    Date of Event
    July 13, 2020
    Report Date
    October 7, 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 1220648-2024-23597. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2024-23597 IN ACCORDANCE WITH UPDATED PROCEDURES. H1 TYPE OF REPORT WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23597. H6 INVESTIGATION CONCLUSIONS CODE 11 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23597.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WITH CARDIOMYOPATHY WAS ON AN IMPELLA FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED ACCESS SITE BLEEDING AND A HEMATOMA. THIS WAS TREATED WITH A BLOOD TRANSFUSION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SUDDEN CARDIAC DEATH, THIS OCCURRED 12 DAYS AFTER THE DEVICE WAS EXPLANTED, THERE IS NO ALLEGATION AGAINST THE DEVICE. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070828 IMPELLA 5.0 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.0 1450376 00813502010053

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention| D