BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 21158714 · Received January 15, 2025

    Report

    Report Number
    1220648-2025-25587
    Event Type
    Death
    Date Received
    January 15, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 17, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MANUFACTURER DEVICE REPORT 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.¿

    Additional Manufacturer Narrative · 0

    B.2 LIFE-THREATENING SHOULD HAD NOT BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25587.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT IN CARDIOGENIC SHOCK FROM AN ACUTE MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AND EXPERIENCED LIMB ISCHEMIA, HEMOLYSIS, AND BLEEDING. THE PATIENT WOULD SUBSEQUENTLY EXPIRE. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER HAVING VENTRICULAR FIBRILLATION ARREST AT HOME. IN THE EMERGENCY DEPARTMENT, THE PATIENT CODED MULTIPLE TIMES, WAS INTUBATED, AND TRANSFERRED TO THE CATHETERIZATION LAB FOR AN ANGIOGRAM. RIGHT CORONARY ARTERY DISEASE WAS NOTED. CARDIOGENIC SHOCK WITH UNSTABLE HEMODYNAMICALLY. THE DECISION WAS MADE TO IMPLANT AN IMPELLA CP DEVICE PRIOR TO PERCUTANEOUS CORONARY INTERVENTION. THE XEXT DAY FOLLOWING THE IMPLANT, PULSES IN THE RIGHT LEG BECAME WEAK AND THE RIGHT FOOT APPEARED MOTTLED. THE LEG BEGAN TO SWELL, AND A FASCIOTOMY WAS SUBSEQUENTLY COMPLETED TO RESTORE PULSE TO THE LEG. FOUR DAYS LATER, PULSE WAS ONCE AGAIN ABSENT IN THE PATIENT'S LEG. THE PATIENT HAD BEEN GIVEN TEN UNITS OF BLOOD AS A RESULT OF THE CONDITION AND INTERVENTION. COINCIDING WITH THE ISCHEMIA, THE PATIENT ALSO DEVELOPED HEMOLYSIS WITH FOUR UNITS OF BLEED BEING GIVEN TO HELP MANAGE THE HEMOLYSIS. THE SUPPORT LEVEL WAS LOWERED TO REDUCE SUCTION THAT MAY HAVE BEEN CONTRIBUTING TO THE HEMOLYSIS. AS A RESULT OF THE PRIOR INTERVENTIONS, THE PATIENT EXPERIENCED BLEEDING COMPLICATIONS FROM THE FASCIOTOMY SITES. MULTIPLE BLOOD PRODUCTS WERE GIVEN TO COUNTERACT THE BLEED AND HEPARIN LEVELS WERE REDUCED. THE PATIENT LATER PASSED AWAY AFTER SEVEN DAYS OF SUPPORT. IT IS UNKNOWN IF THE COMPLICATIONS CONTRIBUTED TO THE PATIENT'S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986737 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025591208 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention| L| D