BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    MDR report key: 25175440 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07851
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED D9 UPDATED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT THE 78 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE PATIENT WAS ALSO ON SUPPORT WITH AN EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) DEVICE. OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. ON DAY 18 OF THE SUPPORT THE CP PUMP STOPPED AND DESPITE ALL RESTARTS THE PUMP WAS EXPLANTED AS THE AUTOMATED IMPELLA CONTROLLER WOULD ALWAYS STATE "MOTOR CURRENT HIGH". THIS STOP ON DAY 18 OCCURRED WELL BEYOND THE INDICATED USE. THE CP WAS EXPLANTED AND NOT REPLACED. THE CONTRIBUTION OF THE ECMO THERAPY CIRCUIT CONTRIBUTING TO THE STOPPAGE IS NOT KNOWN, THOUGH POSSIBLE PER REPORT. THE PATIENT SURVIVED THE PUMP STOP. WHETHER THE PATIENT REMAINED ON ECMO SUPPORT IS NOT KNOWN TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612477 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027864225 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1