BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23569310 · Received November 17, 2025

    Report

    Report Number
    1220648-2025-48392
    Event Type
    Death
    Date Received
    November 17, 2025
    Date of Event
    October 18, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. RESUSCITATION, CARDIAC ARREST: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION (POSITIONING ISSUE): THE CAUSE OF THE POSITIONING ISSUE WAS DETERMINED TO BE AN UNINTENTIONAL USE ERROR AS THE PUMP WAS MOST LIKELY PULLED OUT OF POSITION DURING THE TRANSPORT TO ICU. DEVICE HISTORY LOT: DEVICE LOT: 1980814. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    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.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT HAD COMPLAINTS OF CHEST PAIN AND PRESENTED TO URGENT CARE. AT URGENT CARE, ST ELEVATION WAS NOTED, AND THE PATIENT WAS TRANSFERRED TO A HOSPITAL FOR CARE. UPON ARRIVAL TO THE CARDIAC CATHETERIZATION LABORATORY THE PATIENT WAS DIAPHORETIC AND HYPOTENSIVE. ANGIOGRAM PERFORMED AND FOUND COMPLETE LOSS OF LEFT ANTERIOR DESCENDING CORONARY ARTERY AND LEFT CIRCUMFLEX CORONARY ARTERY DUE TO LEFT MAIN CORONARY ARTERY DISEASE. AN INITIAL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED BUT DURING THE PROCEDURE THE PATIENT BECAME PROGRESSIVELY WORSE WITH CARDIOGENIC SHOCK SYMPTOMS, AND THE DECISION WAS MADE TO IMPLANT AN IMPELLA CP FOR MECHANICAL SUPPORT. THE IMPELLA CP WAS PREPPED AND PLACED WITH NO ISSUES. 2 STENTS WERE DEPLOYED SUCCESSFULLY TO ADDRESS THE BLOCKAGES IN THE PATIENT¿S CORONARY ARTERIES AND RESTORED FLOW. IMPELLA POSITION WAS REVIEWED WITH FLUOROSCOPY, THE PUMP WAS SECURED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR REST AND RECOVERY. UPON ARRIVAL AT ICU, AN ECHOCARDIOGRAM WAS PERFORMED AND FOUND THE IMPELLA CP WAS TRAPPED UNDER PAPILLARY MUSCLE. THE PATIENT CONTINUED TO DECLINE DESPITE INCREASE IN MEDICATION DRIP REQUIREMENT. THE PATIENT WAS VOLUME RESUSCITATED, AND MEDICATIONS WERE INCREASED. THE PATIENT CONTINUED TO DECLINE AND ARRESTED. FOUR ROUNDS OF CARDIOVASCULAR RESUSCITATION WERE PERFORMED AND RETURN OF SPONTANEOUS CIRCULATION COULD NOT BE ACHIEVED. THE PATIENT EXPIRED DURING IMPELLA CP SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872946 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026759922 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death