BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 22987845 · Received September 6, 2025

    Report

    Report Number
    1220648-2025-46180
    Event Type
    Death
    Date Received
    September 6, 2025
    Date of Event
    August 7, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS FOR IMPELLA 5.5 WITH SMARTASSIST SYSTEM: SECTION POTENTIAL ADVERSE EVENTS - ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY¿ (INCLUDING VENTRICULAR PERFORATION).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : STROKE : IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN (B)(4) WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT : DEVICE LOT : 1942023. DEVICE HISTORY BATCH : SUB-COMPONENT LOT : N/A. DEVICE HISTORY REVIEW : THE PUMP S/N: (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS INITIALLY IMPLANTED WITH AN IMPELLA CP AND ESCALATED TO AN IMPELLA 5.5 DEVICE FOR CONTINUATION IN MECHANICAL CIRCULATORY SUPPORT (MCS). THE FOLLOWING DAY AFTER START OF THE IMPELLA 5.5, THE PATIENT HAD A RIGHT M1 OCCLUSION INVOLVING THE MAJORITY OF THE RIGHT TEMPORAL LOBE, FRONTAL AND PARIETAL MID COMPLEXITIES WITH PERFUSION ABNORMALITIES. THE PHYSICIAN NOTED THE FINDING AS GRIM. SUPPORT CONTINUED WITH PLAN TO WEAN AS NECESSARY AND ASSESS FUNCTIONS AND EFFECTS FROM STROKE. THE PATIENT WOULD CONTINUE ON SUPPORT FOR AN ADDITIONAL FOUR DAYS BEFORE EXPIRING. CARE WAS WITHDRAWN GIVEN THE POOR PROGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305229 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026707246 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Disability| L| D