BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25299741 · Received May 27, 2026

    Report

    Report Number
    1220648-2026-08184
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 56 YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) SHOCK STAGE C. THE PATIENT¿S MEDICAL HISTORY WAS NOTABLE FOR CORONARY ARTERY DISEASE AND DIABETES MELLITUS. DURING SUPPORT, THE IMPELLA WAS SET AT PERFORMANCE LEVEL P-8 WITH FLOWS RANGING FROM 3.1¿3.4 LITERS/MIN. HEMATURIA WAS OBSERVED, AS EVIDENCED BY BLOOD NOTED IN THE PATIENT¿S URINE. LABORATORY FINDINGS DEMONSTRATED ELEVATED LACTATE DEHYDROGENASE (LDH). THE DEVICE WAS SUCCESSFULLY WEANED, AND THE PATIENT SURVIVED TO EXPLANT. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AS INTENDED. HEMATURIA AND ELEVATED LDH ARE KNOWN RISKS ASSOCIATED WITH IMPELLA SUPPORT AND MAY BE RELATED TO HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324506 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027854708 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1