BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25183274 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07883
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    May 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    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 5.5 DEVICE WAS INSERTED INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 69-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI D SHOCK, ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AND AN INTRA-AORTIC BALLOON PUMP (IABP). AND ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), PUMP FLOWS DECREASED, MOTOR CURRENT FLAT, AND SUSPECTED CLOT. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM TO REMOVE THE DEVICE. UPON EXPLANT, CLOT WAS SEEN ON THE INLET AND OUTLET. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AS INTENDED AT P-7 AT 4.2L/MIN WITH D5W HEPARIN IN THE PURGE SOLUTION. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THROMBUS (THROMBOSIS) CAN OCCUR DUE TO INADEQUATE ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252783 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027823553 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1