BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 22586066 · Received July 24, 2025

    Report

    Report Number
    1220648-2025-30659
    Event Type
    Death
    Date Received
    July 24, 2025
    Date of Event
    July 8, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF INTRODUCER DAMAGE ¿ MECHANICAL HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. INTRODUCER DAMAGE - MECHANICAL: NO IMAGES OF PRODUCT WERE RETURNED FOR EVALUATION. CLINICAL DETAILS NOTED A SLOW LEAK FROM THE NECK OF THE 23FR AXILLARY INTRODUCER. NO ADDITIONAL DETAILS WERE PROVIDED. THE CAUSE OF THE INTRODUCER DAMAGE COULD NOT BE DEFINITIVELY DETERMINED AS NO PRODUCT WAS RETURNED AND LIMITED CLINICAL DETAILS WERE PROVIDED. B1 ADVERSE EVENT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-30659. B2 DEATH AND DATE OF DEATH WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-30659. B5 PATIENT OUTCOME WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-30659. H1 TYPE OF REPORTABLE EVENT WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-30659. H6 HEALTH EFFECT - CLINICAL CODE 4582 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-30659. H6 HEALTH EFFECT - IMPACT CODE 1802 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-30659.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE PATIENT WAS ON IMPELLA 5.5 SUPPORT AND DURING SUPPORT, THERE WAS A SMALL LEAK FROM THE 23FR PEEL AWAY SHEATH. THE DOCTOR WAS NOT CONCERNED ABOUT LEAK AND CONTINUED TO USE THE SHEATH FOR THE PROCEDURE.

    Description of Event or Problem · 0

    THE DECISION WAS MADE TO WITHDRAW CARE AND THE PATIENT EXPIRED. IT IS UNKNOWN IF THE USE OF THE IMPELLA WAS RELATED TO PATIENT DEATH, THUS THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774861 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026636888 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Death