BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 22282601 · Received June 18, 2025

    Report

    Report Number
    1220648-2025-29417
    Event Type
    Death
    Date Received
    June 18, 2025
    Date of Event
    January 4, 2020
    Report Date
    June 18, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011388
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMARTASSIST SYSTEM, 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: USE OF ECHOCARDIOGRAPHY FOR POSITIONING OF THE IMPELLA CATHETER: ¿EVALUATE THE POSITION OF THE IMPELLA CATHETER IF THE AUTOMATED IMPELLA CONTROLLER DISPLAYS POSITION ALARMS OR IF YOU OBSERVE LOWER THAN EXPECTED FLOWS OR SIGNS OF HEMOLYSIS. IF THE CATHETER DOES NOT APPEAR TO BE CORRECTLY POSITIONED, INITIATE STEPS TO REPOSITION IT.¿ IMPELLA CATHETER TOO FAR INTO THE LEFT VENTRICLE: ¿OBSTRUCTION OF THE IMPELLA CATHETER INLET AREA CAN LEAD TO INCREASED MECHANICAL FORCES ON BLOOD CELL WALLS AND SUBSEQUENT HEMOLYSIS, WHICH OFTEN PRESENTS AS DARK OR BLOOD COLORED URINE.¿ SECTION: HEMOLYSIS: ¿HEMOLYSIS SHOULD BE MONITORED DURING SUPPORT. PATIENTS WHO DEVELOP HIGH LEVELS OF HEMOLYSIS MAY SHOW SIGNS OF DECREASED HEMOGLOBIN LEVELS, DARK OR BLOOD-COLORED URINE, AND IN SOME CASES, ACUTE RENAL FAILURE. PLASMA-FREE HEMOGLOBIN (PFHGB) IS THE BEST INDICATOR TO CONFIRM WHETHER A PATIENT IS EXPOSED TO AN UNACCEPTABLE LEVEL OF HEMOLYSIS.¿ ¿PATIENT CONDITIONS¿ INCLUDING CATHETER POSITION, PRE-EXISTING MEDICAL CONDITIONS, AND SMALL LEFT VENTRICULAR VOLUMES¿ MAY ALSO PLAY A ROLE IN PATIENT SUSCEPTIBILITY TO HEMOLYSIS.¿ SECTION: SUCTION: ¿SUCTION MAY OCCUR IF THE BLOOD VOLUME AVAILABLE FOR THE IMPELLA CATHETER IS INADEQUATE OR RESTRICTED. SUCTION LIMITS THE AMOUNT OF SUPPORT THAT THE IMPELLA CATHETER CAN PROVIDE TO THE PATIENT AND RESULTS IN A DECREASE IN ARTERIAL PRESSURE AND CARDIAC OUTPUT. IT CAN DAMAGE BLOOD CELLS, LEADING TO HEMOLYSIS. IT MAY ALSO BE AN INDICATOR OF RIGHT HEART FAILURE.¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT ENDURED HEMOLYSIS DURING IMPELLA CP SUPPORT. FOLLOWING IMPLANT, THE PATIENT BEGAN TO DEVELOP HEMATURIA. THE SUPPORT LEVEL WAS REDUCED TO P-2 AND THE DEVICE WAS REPOSITIONED TO ADDRESS THE CONDITION. THE FOLLOWING DAY, THE DECISION WAS MADE TO EXPLANT THE PUMP AS THE HEMOLYSIS HAD NOT YET RESOLVED. THE PATIENT PASSED AWAY THE NEXT DAY. THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE THE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748115 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 1415469 00813502011388

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death| O