BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24367564 · Received February 17, 2026

    Report

    Report Number
    1220648-2026-03371
    Event Type
    Death
    Date Received
    February 17, 2026
    Date of Event
    December 24, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION), INCLUDING FURTHER DETAILS REGARDING [SEQUENCE OF EVENTS/CLINICAL COURSE/DEVICE INTERACTION]. E1. UPDATED ZIP CODE EXTENSION.

    Description of Event or Problem · 0

    A 64-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (SCAI STAGE E) REQUIRED TEMPORARY MECHANICAL CIRCULATORY SUPPORT WHILE RECEIVING MULTIPLE INOTROPIC MEDICATIONS, VASOPRESSORS, AND MECHANICAL VENTILATION. BASELINE EVALUATION DEMONSTRATED METABOLIC COMPROMISE, INCLUDING A LACTATE OF 8.5 MILLIMOLES PER LITER, PULMONARY CAPILLARY WEDGE PRESSURE OF 21 MILLIMETERS OF MERCURY, AND LEFT VENTRICULAR END DIASTOLIC PRESSURE OF 21 MILLIMETERS OF MERCURY. A PULMONARY ARTERY CATHETER WAS IN PLACE BEFORE IMPELLA SUPPORT. ON DAY 1 LEFT FEMORAL ARTERIAL ACCESS WAS OBTAINED USING A PERCUTANEOUS, ULTRASOUND GUIDED APPROACH FOR IMPELLA CP IMPLANTATION. THE DEVICE WAS INITIATED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT ON MECHANICAL CIRCULATORY SUPPORT. ON DAY 12 (ACTUAL COMPLAINT ¿ PUMP FLOW ISSUE): DURING ROUTINE ASSESSMENT, STAFF OBSERVED FLOW SATURATION AND DECLINING EFFECTIVE PUMP OUTPUT AFTER NEARLY TWO WEEKS OF CONTINUOUS IMPELLA CP SUPPORT. GIVEN THE DURATION OF USE AND THE RISK OF PUMP STOP, THE CLINICAL CONSULTANT RECOMMENDED DEVICE EXCHANGE. THE IMPELLA CP REMAINED IN USE WHILE THE TEAM ASSESSED NEXT STEPS. THE PATIENT CONTINUED TO DETERIORATE DUE TO CARDIOGENIC SHOCK AND MULTIORGAN DYSFUNCTION. SUPPORT ENDED FOLLOWING WITHDRAWAL OF CARE, AND THE PATIENT SUBSEQUENTLY EXPIRED ON DAY 14 OF SUPPORT. IMPELLA SUPPORT WAS CONTINUED BEYOND THE RECOMMENDED 4 DAY DURATION (OFF-LABEL USE); PROLONGED USE CAN INCREASE THE RISK OF COMPLICATIONS AND THEREFORE MAY HAVE PLAYED A CONTRIBUTORY ROLE IN THIS ADVERSE EVENT THE OBSERVED PUMP FLOW DISTURBANCE IS DEVICE ASSOCIATED BY TIMING AND OCCURRED AFTER AN EXTENDED SUPPORT PERIOD. BASED ON THE AVAILABLE INFORMATION, THE PATIENT¿S SEVERE OVERALL CRITICAL ILLNESS WERE THE MOST LIKELY CONTRIBUTORS TO THE CLINICAL DETERIORATION, FLOW SATURATION, AND EVENTUAL DECISION TO WITHDRAW CARE. DEATH WAS CONSERVATIVELY CODED TO THE IMPELLA CP BY TIMING, WHILE MOST LIKELY CAUSED BY THE UNDERLYING DISEASE AND UNRELATED TO IMPELLA, AS THE DEVICE FUNCTIONED AS EXPECTED IN THE SETTING OF THIS CRITICALLY ILL PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT PUMP WAS SWAPPED FOR A NEW ONE. INTERVENTIONS WERE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431454 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026731857 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death