BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25240758 · Received May 21, 2026

    Report

    Report Number
    1220648-2026-08065
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    May 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INTO THE RIGHT FEMORAL ARTERY IN A 70-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI E SHOCK, AND ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS HEMOLYSIS WITH PINK/LIGHT RED URINE. THE IMPELLA WAS WEANED DOWN FROM P-6 TO P-4 AND RECEIVED FLUID BOLUSES TO INCREASE THE CENTRAL VENOUS PRESSURE (CVP). IT IS UNKNOWN IF THE HEMOLYSIS RESOLVED. AFTER ONE DAY ON SUPPORT, THE DEVICE WAS SUCCESSFULLY WEANED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AS INTENDED AT P-4 AT 2.2L/MIN WITH D5W SODIUM BICARBONATE IN THE PURGE SOLUTION. HEMOLYSIS CAN BE ATTRIBUTED TO MALPOSITION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432087 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027867975 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention