BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25300873 · Received May 27, 2026

    Report

    Report Number
    1220648-2026-08189
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 40-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT HAD A HISTORY OF RENAL INSUFFICIENCY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. AFTER ADMISSION TO THE ICU, A FOLEY CATHETER WAS INSERTED. THE REGISTERED NURSE REPORTED SIGNS OF HEMATURIA, THOUGH IT WAS UNKNOWN IF THIS WAS DUE TO TRAUMATIC INSERTION. THE PATIENT WAS PREPPED FOR TRANSFER FOR HIGHER LEVEL OF CARE. HEMOLYSIS WAS NOTED ON LABORATORY EVALUATION (SPECIFICALLY LDH). THE PATIENT WAS ESCALATED DUE TO HEMODYNAMIC DEMAND, BUT HEMOLYSIS WAS NOT SOLELY ATTRIBUTED TO THE IMPELLA DEVICE. A CONTRIBUTING FACTOR WAS HIGH AFTERLOAD. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AS INTENDED AT P-5, DELIVERING 2.4 L/MIN WITH A PURGE SOLUTION OF DEXTROSE 5% IN WATER (D5W) CONTAINING 25 MEQ/L SODIUM BICARBONATE. THE PATIENT SURVIVED TO EXPLANT. HEMOLYSIS IN THIS PATIENT MAY HAVE RESULTED FROM A COMBINATION OF DEVICE-RELATED FACTORS, UNDERLYING RENAL INSUFFICIENCY, HIGH AFTERLOAD, AND THE SEVERITY OF CARDIOGENIC SHOCK DURING IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266381 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026775690 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other