BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24419916 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03837
    Event Type
    Death
    Date Received
    February 23, 2026
    Date of Event
    November 29, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6, MEDICAL DEVICE PROBLEM CODE: A0709, DEVICE SENSING PROBLEM, AND A01, PATIENT DEVICE INTERACTION PROBLEM, WERE ADDED.

    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.

    Description of Event or Problem · 0

    A 50-YEAR-OLD MALE PATIENT TREATED WITH IMPELLA 5.5 DUE TO ACUTE DECOMPENSATED CARDIOMYOPATHY. PATIENT BEING PREVIOUSLY SUPPORTED BY IMPELLA CP AND THEN SWITCHED TO IMPELLA 5.5 SUPPORT. AFTER INSERTION PATIENT NOT ON SYSTEMIC ANTICOAGULATION DUE TO OOZING AROUND RIGHT AXILLARY SITE. ONE UNIT OF PACKED RED BLOOD CELLS GIVEN OVERNIGHT AND ADDITIONAL UNIT OVER NIGHT. DAY ONE OF IMPELLA 5.5 SUPPORT PURGE SYSTEM BLOCKED ALARM AND TISSUE PLASMINOGEN ACTIVATOR BEING USED AS PURGE FLUID. RENAL REPLACEMENT THERAPY INITIATED AND PATIENT ALSO SHOWING SIGNS OF PANCREATITIS THEREFORE CODED FOR INFLAMMATION. AFTER 2.5 WEEKS CONTROLLER ERROR ALARM OCCURRED, DISPLAYING A MOTOR CURRENT AND FLOW, BUT NO PLACEMENT SIGNAL OR LV WAVEFORM. THE CONTROLLER ERROR ALARM LASTED 3 MINUTES AND THEN RESOLVED. HCPS DID NOT WANT TO MAKE AN AUTOMATED IMPELLA CONTROLLER SWITCHED EVEN THOUGH ADVISED TO DO SO. LATER THAT SAME DAY INFORMATION WAS SHARED THAT ALARM HAPPENED TWO MORE TIMES AND CONTROLLER SWITCH WAS INITIATED. WHEN THE PUMP WAS PLUGGED INTO SWITCHED CONTROLLER, THE PUMP PLACEMENT SIGNAL WAS LOST AND ALARM ON CONTROLLER SHOWED PLACEMENT SIGNAL NOT RELIABLE YELLOW ALARM. THE PATIENT'S HEMODYNAMICS WERE UNCHANGED. PATIENT EXPERIENCING SUCTION ALARMS AND IMPELLA MEASURING 6CM FROM AORTIC VALVE, WHICH IS LOWER THAN RECOMMENDED AND HCP PLANNING TO REPOSITION. AFTER 1.5 MONTHS OF SUPPORT PUMP ALARMED THAT THE PURGE DISC WAS NOT DETECTED. CHANGE OF PURGE CASSETTE WAS NOT POSSIBLE AND AUTOMATED IMPELLA CONTROLLER HUNG UP ON INSERT PURGE DISC SCREEN. WITH ONSITE SUPPORT PURGE CASSETTE COULD NOT BE CHANGED AS IT WAS NOT DETECTED BY CONTROLLER. CONTROLLER CHANGE NOT RECOMMENDED AS PREVIOUS PLACEMENT SIGNAL ISSUE NOT RELIABLE OF PUMP IS STILL PRESENT. AFTER MORE THAN 1.5 MONTHS PATIENT CARE WAS WITHDRAWN AND PATIENT EXPIRED, THEREFORE VERY CONSERVATIVELY CODED ON DEATH. THROMBOSIS DURING IMPELLA SUPPORT IS MOST LIKELY DUE TO THE COMBINED EFFECTS OF CRITICAL-ILLNESS¿RELATED HYPERCOAGULABILITY AND DEVICE-RELATED BLOOD FLOW DISTURBANCES. DEATH WAS CONSERVATIVELY CODED AS MOST LIKELY DUE TO UNDERLYING DISEASE AND NOT DEVICE-RELATED. IMPELLA SUPPORT WAS CONTINUED BEYOND THE RECOMMENDED 14 DAY DURATION; PROLONGED USE CAN INCREASE THE RISK OF COMPLICATIONS AND THEREFORE MAY HAVE PLAYED A CONTRIBUTORY ROLE IN THIS ADVERSE EVENT. 5.5 - PURGE PRESSURE HIGH: COMPLAINT NOTED A PURGE PRESSURE HIGH ALARM TRIGGER ON THE CONSOLE, INDICATE A POTENTIAL BLOCKAGE AT THE ROTOR GAP. PURGE FLUID WAS CHANGED TO TPA AS A MITIGATION. AIC 1 (SN: (B)(6)) CONTROLLER FAILURE/ERROR & AIC 2 (SN: (B)(6)) PLACEMENT SIGNAL ISSUE FIRST CONTROLLER SHOWED A YELLOW CONTROLLER ERROR ALARM. CONSOLE WAS REPLACED WITH A BACK UP. WHEN ON THE BACK UP CONSOLE, A PLACEMENT SIGNAL NOT RELAIBLE ALARM TRIGGERED. PURGE DISK NOT DETECTED ALARM WAS TRIGGERED ON THE CONSOLE, 3 HOURS AFTER A PURGE CASSETTE CHANGE OCCURRED. TO MITIGATE THIS, A NEW CASSETTE WAS USED, BUT THE CONTROLLER WAS UNABLE TO DETECT THE PURGE DISC RESULTING IN NOT BEING ABLE TO COMPLETE THE PURGE CASSETTE REPLACEMENT PROCEDURE. SITE MADE DECISION TO NOT REPLACE THE CONTROLLER BECAUSE OF AN ACTIVE PLACEMENT SIGNAL ALARM. COMPLAINT NOTES PATIENT HEMODYNAMICS WERE UNCHANGED, AND AS A RESULT, THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450135 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 2026735831 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| D