BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24224937 · Received January 30, 2026

    Report

    Report Number
    1220648-2026-01983
    Event Type
    Death
    Date Received
    January 30, 2026
    Date of Event
    January 21, 2026
    Report Date
    January 30, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY PPAE (ISCHEMIA): IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN (B)(4) WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT DEVICE LOT: 1980827. DEVICE HISTORY BATCH SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW. THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS PLACED VIA THE FEMORAL ARTERY TO SUPPORT THE 66 YEAR OLD FEMALE PATIENT ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK WITH A KNOWN ARREST AND ADMINISTERED CPR, ON A VENT FOR RESPIRATORY NEEDS, AND IN SCAI STAGE E SHOCK. ANY OTHER UNDERLYING CARDIAC OR SYSTEMIC COMORBIDITIES ARE UNKNOWN. THE FEMORAL ARTERY WAS NOTED TO BE >/= 4MM IN DIAMETER BUT, THE LIMB BECAME ISCHEMIC AND PULSES WERE LOST AFTER THE INTRODUCER WAS REMOVED, REPOSITIONING SHEATH DELIVERED, AND THE PATIENT WAS ADMITTED TO THE ICU FOR CONTINUED SUPPORT. THE TEAM ADJUSTED THE PUMP PLACEMENT PER STANDARD PRACTICE, IMAGED THE VESSEL WITH ULTRASOUND, AND GAVE BOTH THROMBOLYTICS AND VASODILATORS TO TREAT THE VESSEL ISCHEMIA. THE TEAM DID NOTE THE PATIENT MAY HAVE BEEN CLAMPED DOWN DUE TO HIGH SYSTEMIC RESISTANCE. ON DAY 2 OF THE SUPPORT THE TEAM AND FAMILY MADE CHOICE TO WITHDRAW CARE AND THE PATIENT EXPIRED. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288577 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026760497 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death| R