BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24176564 · Received January 26, 2026

    Report

    Report Number
    1220648-2026-01492
    Event Type
    Death
    Date Received
    January 26, 2026
    Date of Event
    January 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE ARRHYTHMIA WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE PUMP PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    A4, A5, AND A6 ARE UNKNOWN. 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

    A 79-YEAR-OLD FEMALE PATIENT WITH AN INDICATION FOR USE OF THE IMPELLA CP DEVICE FOR ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK UNDERWENT PREPARATION FOR IMPELLA SUPPORT. THE PROCEDURE BEGAN WITH PLACEMENT OF A 14F SHEATH IN THE RIGHT FEMORAL ARTERY WITHOUT ISSUE. A 6F ANGLED PIGTAIL CATHETER WAS ADVANCED ACROSS THE AORTIC VALVE, AND A 0.018 × 260 CM WIRE WAS POSITIONED IN THE LEFT VENTRICLE. DURING PREPARATION OF THE IMPELLA CP CATHETER (SN (B)(6), PC (B)(4), GU (B)(4), THE PATIENT DEVELOPED CARDIAC ARREST AND PROGRESSED TO CODING. DESPITE RESUSCITATIVE EFFORTS, THE PATIENT EXPIRED PRIOR TO IMPELLA INSERTION, RESULTING IN ABORTED PLACEMENT. BASED ON THE AVAILABLE PROCEDURAL DETAILS, THE PATIENT WAS IN SEVERE CARDIOGENIC SHOCK SECONDARY TO AN ACUTE MYOCARDIAL INFARCTION, AND THE DETERIORATION OCCURRED BEFORE DEVICE INSERTION, DURING STANDARD PREPARATION STEPS. THE EVENT APPEARS TO BE CONSISTENT WITH THE PATIENT¿S CRITICAL UNDERLYING CONDITION RATHER THAN RELATED TO IMPELLA DEVICE FUNCTION. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA CP BUT IS UNLIKELY A CONTRIBUTING FACTOR AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574010 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026805401

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death