BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 23760788 · Received December 9, 2025

    Report

    Report Number
    1220648-2025-48877
    Event Type
    Death
    Date Received
    December 9, 2025
    Date of Event
    November 10, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. PERICARDIAL EFFUSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ACCESS SITE ADVERSE EVENT: THE CAUSE OF THE BLEED WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1842983. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    COMPLAINT CODING WAS UPDATED TO BETTER REFLECT THE REPORTED EVENT. CONSEQUENTLY, SECTION H6 HEALTH EFFECT CLINICAL CODES WERE CORRECTED AND REPOPULATED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 HAD BLEEDING AT THE ANASTOMOSIS SITE. THE PATIENT WAS TRANSFUSED MULTIPLE UNITS OF RED BLOOD CELLS AND PLATELETS. ADDITIONALLY, THE PATIENT CODED MULTIPLE TIMES. THE PATIENT EXPIRED ON IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2771948 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025561186 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Death