BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25318488 · Received May 28, 2026

    Report

    Report Number
    1220648-2026-08232
    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
    MA, 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 59-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). PATIENT'S COMORBIDITIES WERE NOT REPORTED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. STAFF REPORTED BLEEDING FROM BOTH THE IMPELLA AND ECMO SITES. HEMOSTASIS WAS ACHIEVED WITH A FEMSTOP AT THE IMPELLA ACCESS SITE. THE PATIENT RECEIVED 8 UNITS OF PACKED RED BLOOD CELLS AND 3 UNITS OF FRESH FROZEN PLASMA. DISTAL PULSES REMAINED POSITIVE. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AS INTENDED AT P-6, DELIVERING 2.9 L/MIN WITH A PURGE SOLUTION OF DEXTROSE 5% IN WATER (D5W) CONTAINING 25 MEQ/L SODIUM BICARBONATE. THE PATIENT SURVIVED TO EXPLANT. BLEEDING MAY HAVE RESULTED FROM ACCESS-SITE COMPLICATIONS, ANTICOAGULATION REQUIREMENTS, AND THE CRITICAL ILLNESS ASSOCIATED WITH IMPELLA AND ECMO SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213891 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027838874 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention EXTRACORPOREAL MEMBRANE OXYGENATION