BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25254327 · Received May 22, 2026

    Report

    Report Number
    1220648-2026-08116
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 WAS INSERTED INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 68-YEAR-OLD FEMALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI E SHOCK, ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AND ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED AS AN ESCALATION OF THERAPY FROM AN IMPELLA CP. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PURGE FLOW DECREASED TO 2.8 AND PURGE PRESSURE INCREASED TO 900'S. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS INITIATED AND ANGIOMAX DRIP STARTED. THERE WAS NO NOTED INTERRUPTION OF FLOW OR SUPPORT FOR THE PATIENT. THE POST-PROCEDURE OUTCOME IS UNKNOWN. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AS INTENDED AT P-6 AT 3.4L/MIN WITH D5W SODIUM BICARBONATE IN THE PURGE SOLUTION. THE TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS UTILIZED FOR THE HIGH PP TO MITIGATE IMPACT OF BIOMATERIAL WITHIN THE MOTOR AND THERE WAS NO IMPACT ON THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT SURVIVED EXPLANT, AND THE DEVICE IS RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375809 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027865753 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1