BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25145899 · Received May 12, 2026

    Report

    Report Number
    1220648-2026-07746
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT ELECTIVE PLACEMENT OF AN IMPELLA 5.5 DEVICE VIA DIRECT SURGICAL ACCESS TO THE RIGHT SIDE OF THE AORTA, WITH THE PRE-SUPPORT CLINICAL STATE DOCUMENTED AS SCAI SHOCK STAGE D. THE DEVICE IMPLANTED ON (B)(6) 2026 AT 14:05 AND REMAINS ON SUPPORT AT THE TIME OF THIS REPORT. DURING THE CLINICAL COURSE, THE PATIENT EXPERIENCED BLEEDING FROM VENOUS GRAFTS AT THE AORTA, FOR WHICH MULTIPLE BLOOD PRODUCTS WERE ADMINISTERED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION AND NO IMPLICATION OF THE IMPELLA SYSTEM IN THE BLEEDING EVENT PER THE REPORTING SOURCE. THE PATIENT REMAINS ON SUPPORT AT THE TIME OF REPORTING. THIS EVENT IS LIKELY ATTRIBUTED TO A CLINICAL COMPLICATION RELATED TO SURGICAL GRAFT BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574082 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027817778 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1