BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23727503 · Received December 5, 2025

    Report

    Report Number
    1220648-2025-48781
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 6, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THE PUMP AND DATA LOGS WERE NOT RETURNED FOR INVESTIGATION THROMBOSIS: AS PER CLINICAL, ECHO SHOWED CLOT ON THE TIP OF CATHETER ON (B)(6) 2025. IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. SATURATED FLOW: AS PER CLINICAL SATURATED FLOW WAS OBSERVED OVERNIGHT ON (B)(6) 2025. THE CAUSE OF SATURATED PUMP FLOW WAS NOT DETERMINED SINCE NO PUMP/DATA LOGS WERE RETURNED FOR INVESTIGATION. PUMP STOP: AS PER CLINICAL PUMP STOPPED NEXT DAY MORNING ON (B)(6) SINCE PUMP SATURATION ON (B)(6) 2025. THE CAUSE OF PUMP STOP WAS NOT DETERMINED SINCE NO PUMP/DATA LOGS WERE RETURNED FOR INVESTIGATION. DEVICE HISTORY LOT DEVICE LOT: 1980884 DEVICE HISTORY BATCH SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW THE PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE IS UNAVAILABLE FOR RETURN FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿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)¿ SECTION: WARNINGS & CAUTIONS: WARNINGS: SECTION: PRE-SUPPORT EVALUATION SECTION: AXILLARY INSERTION OF THE IMPELLA 5.5 CATHETER SECTION: DIRECT AORTIC INSERTION SECTION: USE OF IMPELLA WITH TRANSCATHETER AORTIC VALVES "IN PATIENTS WITH TRANSCATHETER AORTIC VALVES POSITION THE IMPELLA SYSTEM CAREFULLY TO AVOID INTERACTION WITH THE TRANSCATHETER AORTIC VALVE PROSTHESIS. UNINTENTIONAL INTERACTION OF THE IMPELLA MOTOR HOUSING WITH THE TAVR DEVICE MAY RESULT IN DESTRUCTION OF THE IMPELLER BLADES. THIS CAN LEAD TO SYSTEMIC EMBOLIZATION, SERIOUS INJURY, OR DEATH." . IN THIS SITUATION, AVOID REPOSITIONING WHILE THE DEVICE IS RUNNING; TURN THE DEVICE TO P0 DURING REPOSITIONING OR ANY MOVEMENT THAT COULD BRING THE OUTLET WINDOWS INTO PROXIMITY TO THE VALVE STENT STRUCTURES. IF THERE IS LOW FLOW OBSERVED IN A PATIENT IMPLANTED WITH A TRANSCATHETER AORTIC VALVE PROSTHESIS, CONSIDER DAMAGE OF THE IMPELLER AND REPLACE THE IMPELLA AS SOON AS POSSIBLE.¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, PUMP SATURATION WAS NOTED OVERNIGHT. ECHOCARDIOGRAM (ECHO) SHOWED A CLOT ON THE TIP ON CATHETER. THE PUMP STOPPED SHORTLY AFTER ECHO. THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENT THE IMPELLA 5.5 AND ANOTHER REPORT WILL BE SUBMITTED TO REPRESENT THE IMPELLA CP. REFER TO SECTION H10 FOR THE RELATED REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2754197 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026748366 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention