BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24171491 · Received January 23, 2026

    Report

    Report Number
    1220648-2026-01438
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    January 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY MAJOR BLEED / ANEMIA : THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 PUMP WAS INSERTED VIA THE AXILLARY GRAFT FOR THE 67 YEAR OLD MALE PATIENT ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, IN SCAI STAGE E SHOCK. PRIOR TO THE 5.5 PLACEMENT, THE PATIENT WAS ON AN INTRA-AORTIC BALLOON PUMP, INOTROPES/VASOPRESSORS, AND WAS VENTED FOR RESPIRATORY NEEDS. ON DAY 6 OF THE SUPPORT THE PATIENT HAD A DROP IN HEMOGLOBIN LEVELS AND THERE WAS A NASOPHARYNGEAL BLEEDING. THE PATIENT HAD 2 UNITS OF BLOOD PRODUCTS INFUSED BACK TO THE PATIENT. THE PATIENT WAS ON SYSTEMIC ANTICOAGULATION. THE NEXT DAY OF SUPPORT, DAY 7, THE PUMP WAS EXPLANTED. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233854 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026780984

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention