BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24641435 · Received March 19, 2026

    Report

    Report Number
    1220648-2026-05669
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    November 27, 2025
    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
    PA, 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 64-YEAR-OLD FEMALE PATIENT WAS ADMITTED WITH DE NOVO CARDIOMYOPATHY. THE MD ATTEMPTED TO PLACE AN IMPELLA 5.5, HOWEVER, WAS UNABLE TO ADVANCE IT INTO THE AORTA DUE TO THE PATIENT ANATOMY. MD UNABLE TO PASS 5.5 FROM AXILLARY ARTERY INTO AORTA DUE TO PATIENT ANATOMY. THE DECISION WAS MADE TO PLACE AN IMPELLA CP VIA AXILLARY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700099 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026757627 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention