BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25315901 · Received May 28, 2026

    Report

    Report Number
    1220648-2026-08215
    Event Type
    Injury
    Date Received
    May 28, 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
    CA, 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 WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 57-YEAR-OLD FEMALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE UNKNOWN. THE PATIENT¿S COMORBIDITIES WERE NOT REPORTED. DURING IMPELLA CP SUPPORT, THERE WAS CONCERN FOR HEMOLYSIS, ACCOMPANIED BY A DECREASE IN PLATELET COUNT. FURTHER CLINICAL DETAILS WERE NOT AVAILABLE AT THE TIME OF REPORTING. IMAGING ASSESSMENT CONFIRMED APPROPRIATE PUMP POSITIONING AT THE TIME OF THE REPORTED HEMOLYSIS. THE PURGE SOLUTION CONSISTED OF DEXTROSE 5 PERCENT IN WATER (D5W) WITH 25 MILLIEQUIVALENTS PER LITER OF SODIUM BICARBONATE. THE DEVICE WAS FUNCTIONING AT PERFORMANCE LEVEL P-7 WITH FLOWS OF APPROXIMATELY 3.3 LITERS PER MINUTE. THE PATIENT REMAINED ON IMPELLA CP SUPPORT AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163885 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026789144 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other