BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24628235 · Received March 18, 2026

    Report

    Report Number
    1220648-2026-05575
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    December 22, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE TO ADVANCE: THE CAUSE OF THE FAILURE TO ADVANCE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD DIFFICULT ANATOMY PREVENTING SUCCESSFUL DELIVERY OF IMPELLA. 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 TWENTY YEAR OLD FEMALE WAS TREATED FOR DE-NOVO CARDIOMYOPATHY. INSERTION OF AN IMPELLA 5.5 WAS PLANNED, BUT ABORTED AS THE PUMP COULD NOT BE ADVANCED DUE TO THE PATIENT'S ANATOMY. NO OTHER IMPELLA PUMP WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688659 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026795445 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female