BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23451691 · Received November 3, 2025

    Report

    Report Number
    1220648-2025-48011
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 5, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. OPTICAL SENSOR ISSUE/PUMP SUCTION: THE CLINICAL DETAILS STATE THAT THE LV SIGNAL BECAME DISCONNECTED FROM THE AO PS AND THERE WAS SUCTION AT P-5. THE DATA LOGS SHOW THAT THERE WAS SUCTION ALARM #14 TRIGGERING ON 10/04 AND THEN TRIGGERING AGAIN AT THE TIME OF THE REPORTED EVENT ON 10/05. DURING THIS TIME THE LVPS CAN BE SEEN TO BEGIN TO MILDLY DECOUPLE FROM THE AO PS, AS THE MOTOR CURRENT MAX BEGAN TO TREND DOWN GRADUALLY CAUSING A TREND UP IN THE DPMIN. THE PLACEMENT SIGNAL REMAIN RELATIVELY STABLE DURING THIS TIME ALONG WITH SNR AND THE REST OF THE 5S PARAMETERS. THIS ISSUE SEEMS TO RESOLVE WITH ADJUSTMENTS OF THE P-LEVELS AND SUCTION IS NOT TRIGGERED FOR THE DURATION OF THE TWO DAYS. THERE WERE NO MOTOR CURRENT SPIKES OR DRASTIC CHANGES OF FLOW DURING THIS TIME. DUE TO LACK OF CLINICAL DETAILS REGARDING POSITIONING OF THE PUMP AND NO PRODUCT RETURNED, THE ROOT CAUSE OF THE OPTICAL SENSOR ISSUE AND THE SUCTION ISSUE CANNOT BE ESTABLISHED. HYPOTENSION: THE CAUSE OF THE CLINICAL SYMPTOM CANNOT BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1960372. DEVICE HISTORY BATCH: SUBCOMPONENT: N/A. DEVICE HISTORY REVIEW: IMPELLA 617314 PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A PATIENT WAS PLACED ONTO IMPELLA CP SUPPORT DUE TO ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK. WHILE ON SUPPORT, THE PATIENT EXPERIENCED HYPOTENSION FOLLOWED BY LOSS OF PLACEMENT SIGNAL. THE PUMP PRESENTED SUCTION ISSUES WITH NO SPECIFIED RESOLUTION. LATER, THE PATIENT WAS SUCCESSFULLY EXPLANTED AND SURVIVED. ADDITIONAL INFORMATION WAS RECEIVED. THE AREA MANAGER DOES NOT HAVE THE PUMP TO RETURN. THE DECOUPLING MANIFESTED DUE TO LOW CARDIAC OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078070 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026730399 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other