BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24545993 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04768
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    November 10, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 BRAND NAME. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 59 YEAR OLD MALE PRESENTED WITH TACHYCARDIA AND CHEST PAIN. AN IMPELLA CP WAS PLACED PRIOR TO DIAGNOSTIC ANGIOGRAPHY. AS THE PATIENT CONTINUED TO DETERIORATE, THERAPY WAS ESCALATED TO VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION AND THE PATIENT WAS PRESENTED FOR CORONARY ARTERY BYPASS GRAFTING. DURING THE PROCEDURE, THE IMPELLA CP WAS UPGRADED TO AN IMPELLA 5.5. THE PATIENT ALSO REQUIRED BLOOD PRODUCTS FOR A GASTROINTESTINAL BLEEDING THAT SUPPOSEDLY HAPPENED PRIOR TO SURGERY. AFTER 4 DAYS OF SUPPORT ON IMPELLA 5.5, THE PATIENT DEVELOPED A FEVER AND BLOOD CULTURES WERE TAKEN BUT REMAINED NEGATIVE. THE IMPELLA 5.5 COULD BE SUCCESSFULLY WEANED AND REMOVED AFTER 7 DAYS OF SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610683 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026746961 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention