BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23896000 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49448
    Event Type
    Death
    Date Received
    December 26, 2025
    Date of Event
    September 19, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    0081302012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. ISCHEMIA: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PUMP SUCTION: NO PRODUCT WAS RETURNED. PT HAD MULTIPLE PEAS, RESULTING IN SUCTION ALARMS. AFTER REVIEWING LOGS, MULTIPLE SUCTION ALARMS WERE OBSERVED ALONG WITH IMPELLA IN AORTA ALARMS. THE LOGS SHOW SUCTION ALARMS THROUGHOUT THE CASE AND PATIENT HAD POOR PROGNOSIS AND WAS ON ECMO SUPPORT AS WELL. THE CAUSE OF PUMP SUCTION WAS MOST LIKELY PATIENT CONDITION RELATED SINCE PATIENT HAD POOR PROGNOSIS AND PATIENT BEING IN ECMO SUPPORT. DEVICE HISTORY LOT: DEVICE LOT: 1974839. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT HAD SEVERAL PULSELESS ELECTRICAL ACTIVITY (PEA) RESULTING IN SUCTION ALARMS, THE CATHETER WAS REPOSITIONED, AND VOLUME STATUS WAS IMPROVED. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT'S EXTREMITIES ARE BLACK, A VASCULAR STUDY WAS CONDUCTED AND NOTED THAT THERE WAS NO FLOW DOWN EITHER THE LEG OR ARMS. THE PATIENT HERNIATED AND A BRAIN DEATH TEST WAS INITIATED; THE PATIENT WAS DECLARED BRAIN DEAD AND DIED WHILE ON SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564479 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026724222 0081302012279

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Death