BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24231225 · Received February 2, 2026

    Report

    Report Number
    1220648-2026-02030
    Event Type
    Death
    Date Received
    February 2, 2026
    Date of Event
    October 23, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    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

    B5 AND D4 (UDI) UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    D1 BRAND NAME WAS UPDATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF ASAE WAS MOST LIKELY USE ISSUE RELATED DUE TO ANTICOAGULATION MANAGEMENT SINCE HEPARIN DRIP WAS STOPPED AND BLEEDING RESOLVED.

    Description of Event or Problem · 0

    ON (B)(6)2025, 88-YEAR-OLD MALE PRESENTED TO (B)(6) HOSPITAL FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION WITH AN EJECTION FRACTION OF 5%. ON THIS DATE THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL VIA AMBULANCE. UPON ARRIVAL PATIENT HAD RIGHT GROIN HEMATOMA. PRESSURE WAS HELD BY PHYSICIAN. HEMATOMA IMPROVED. ON POST PLACEMENT DAY 1 HEPARIN LEVEL NOTED TO BE SUBTHERAPEUTIC. HEPARIN PURGE SOLUTION STARTED AND HEPARIN DRIP STARTED. PATIENT NOTED TO HAVE ECCHYMOSIS OF RIGHT GROIN WITH SITE NOTED TO BE SOFT AND NON-TENDER. TWO DAYS POST PLACEMENT PATIENT NOTED TO HAVE DECREASED MIXED VENOUS WITH INCREASE IN CARDIAC OUTPUT WITH CONCERN FOR BLEEDING WITHOUT HEMOGLOBIN DROP. SIGNIFICANT GROIN BLEEDING NOTED THE EVENING OF (B)(6) TO (B)(6). HEPARIN DRIP STOPPED AND BLEEDING RESOLVED. ON (B)(6) 2025 PATIENT MADE A DO NOT RESUSCITATE WITH IMPELLA EXPLANTED. PATIENT EXPIRED. THE IMPELLA CP WILL BE CODED FOR HEMATOMA AND MAJOR BLEED DUE TO THE ANTICOAGULATION REQUIREMENTS FOR DEVICE IMPLANT AND MAINTENANCE. THE IMPELLA CP WILL BE CONSERVATIVELY REPORTED FOR DEATH BUT IS KNOWN TO BE UNLIKELY RELATED AS THE DEVICE PERFORMED AS EXPECTED AND THE DEATH IS MOST LIKELY CAUSED BY THE UNDERLYING CRITICAL CONDITION OF THE PATIENT AND THE DECISION TO WITHDRAW CARE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED ADDITIONAL INFORMATION UPON REQUEST: "THE INTERVENTION WAS SUCCESSFUL. I DO NOT HAVE THE PUMP FOR RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609227 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 371 14F LT CMR SET 2026728561 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Death