BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24402094 · Received February 20, 2026

    Report

    Report Number
    1220648-2026-03688
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    December 21, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. D9 UPDATED. H6 MEDICAL DEVICE PROBLEM CODE A140505 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Description of Event or Problem · 0

    A 48-YEAR-OLD MALE WITH A HISTORY OF CORONARY ARTERY DISEASE, DIABETES MELLITUS, RENAL INSUFFICIENCY, AND DIALYSIS RECEIVED AN IMPELLA 5.5 FOR ACUTE HEART FAILURE DUE TO ISCHEMIC CARDIOMYOPATHY WHILE SUPPORTED WITH TWO INOTROPIC MEDICATIONS, AN INTRA-AORTIC BALLOON PUMP, AND MECHANICAL VENTILATION. THE PATIENT WAS POSITIVE FOR HEPARIN-INDUCED THROMBOCYTOPENIA AND WAS TREATED WITH ARGATROBAN, WITH AN ACTIVATED CLOTTING TIME OF 193 SECONDS AT THE TIME OF INSERTION. THE FIRST IMPELLA 5.5 ENCOUNTERED DIFFICULTY CROSSING THE AORTIC VALVE AND LATER GENERATED PURGE SYSTEM BLOCKAGE ALARMS, LEADING TO REMOVAL AND REPLACEMENT. THE SECOND DEVICE WAS MORE DIFFICULT TO INSERT DUE TO REPEATED LOSS OF WIRE POSITION BUT WAS ULTIMATELY PLACED SUCCESSFULLY WITH NORMALIZED ACTIVATED CLOTTING TIME. INITIAL ISSUES WITH LEFT VENTRICULAR AND AORTIC PRESSURE WAVEFORMS AND PUMP PERFORMANCE RESOLVED BY THE END OF THE PROCEDURE. THIS WILL BE CODED IN DETAIL BY ENGINEERING TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463471 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2026753181 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention