BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 23897172 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49438
    Event Type
    Death
    Date Received
    December 26, 2025
    Date of Event
    September 19, 2025
    Report Date
    December 26, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : MAJOR BLEED: HEPARIN WAS HELD DURING THE CASE DUE TO A GI BLEED AND A NOSEBLEED LATER ON AS WELL. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE CAUSE OF THE BLEEDING COULD NOT BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. STROKE: 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. PUMP SUCTION: CLINICAL REPORTED THAT SUCTION BEGAN TO TRIGGER MULTIPLE TIMES WHEN THE PATIENT WAS STANDING UP. FLUIDS WERE GIVEN AND SUCTION REPORTEDLY RESOLVED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. DATA LOG REVIEW CONFIRMS SUCTION EVENTS OCCURRING ON THE DAY IT WAS REPORTED. AT THE SAME TIME SUCTION STARTED, AN IMPELLA POSITION UNKNOWN ALARM TRIGGERED AS WELL. THE PLACEMENT SIGNAL AT THIS TIME LOSES PULSATILITY, AND THE PLACEMENT SIGNAL WAVEFORMS ARE NO LONGER AORTIC AT THIS TIME. THERE WERE NO MOTOR CURRENT SPIKES DURING THE CASE. THE CAUSE OF THE SUCTION IS MOST LIKELY PATIENT RELATED, AS PLACEMENT SIGNAL LOSES PULSATILITY AT THE TIME OF SUCTION, AND SUCTION REPORTEDLY RESOLVED WITH VOLUME. DEVICE HISTORY LOT:DEVICE LOT NUMBER: 1951079. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW : PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CRITERIA.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE DEVICE EXHIBITED SUCTIONS ISSUES, THE PATIENT WAS ADMINISTERED LACTATED RINGER'S AND 1 UNIT OF PACKED RED BLOOD CELLS (PRBC). NO FURTHER SUCTION ISSUES WERE REPORTED. ADDITIONALLY, THE PATIENT EXPERIENED A GASTROINTESTINAL BLEED AND HEPARIN WAS WITHHELD. NO FURTHER INFORMATION WAS PROVIDED; HOWEVER, IT WAS LATER REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319873 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026714430 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Death