BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 22435507 · Received July 8, 2025

    Report

    Report Number
    1220648-2025-30105
    Event Type
    Death
    Date Received
    July 8, 2025
    Date of Event
    June 19, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR VENTRICULAR TACHYCARDIA (VT,) POSITIONING ISSUES, LOW PUMP FLOW, AND THROMBUS HAS BEEN COMPLETED. CLINICAL DETAILS STATE THAT THE PATIENT SUFFERED A PEA ARREST OVERNIGHT. PATIENT HAD VTACH ARREST AND FAMILY DECIDED TO MAKE PATIENT DNR. THE ROOT CAUSE OF THE PEA ARREST/VTACH ARREST WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE POSITIONING ISSUES WAS MOST LIKELY PATIENT CONDITION RELATED AS THE CLINICAL DETAILS STATED THE PUMP WAS LEFT DEEP DUE TO HYPOKINESIS OF LV. THE CAUSE OF THE LOW PUMP FLOW WAS MOST LIKELY PATIENT CONDITION RELATED AS CLINICAL DETAILS NOTED RV DYSFUNCTION, HIGH SVR, HYPOKINESIS OF THE LV, AND GIVING VOLUME TEMPORARILY RESOLVED SUCTION, WHICH CORRESPONDED WITH THE TRENDS SEEN IN THE DATA LOGS. THE ROOT CAUSE OF THE THROMBUS WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE 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 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 USER FACILITY REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP POST PROCEDURE FOR ST-ELEVATION MYOCARDIAL INFARCTION AND HAD TO BE LEFT IN A DEEPER POSITION DUE TO HYPO-KINESIS OF LEFT VENTRICLE. THE SITE WAS APPROPRIATELY DRESSED AND GROIN BEST PRACTICES WERE USED. NO BLEEDING OR HEMATOMA AT THE GROIN SITE WERE NOTED. DURING SUPPORT, IT WAS NOTED THAT THE PATIENTS VITALS BEGAN TO CRASH AND CODE WAS CALLED. ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS PROVIDED FOR A TOTAL OF FIVE MINUTES WHICH OBTAINED RETURN OF SYSTEMIC CIRCULATION. AN ECHOCARDIOGRAM SHOWED DEEP PLACEMENT. HOWEVER, THE PHYSICIAN WAS UNABLE TO GET THE CATHETER IN A BETTER POSITION SO IT IS STILL CURRENTLY AROUND FIVE CENTIMETERS IN THE VENTRICLE. THE PATIENT'S FEET WERE NOTED TO BE COOL BILATERALLY SO BILATERAL LOWER EXTREMITY (BLE) ARTERIAL DOPPLER WAS COMPLETED. PER THE PRELIMINARY REPORT, BOTH LEGS HAD ADEQUATE FLOW. THE PATIENT WAS STILL MECHANICALLY VENTILATED AND SEDATED. THE PATIENT DID SUFFER A PULSELESS ELECTRICAL ACTIVITY ARREST WHILE TURNING THE PATIENT REQUIRING TWO ROUNDS OF CARDIOPULMONARY RESUSCITATION AND ACLS MEDICATIONS. IN ADDITION, IT WAS NOTED THAT THE ECHOCARDIOGRAM WAS COMPLETED AND THE IMPELLA CP WAS PULLED BACK TO A NEW LANDMARK. A LEFT VENTRICLE THROMBUS WAS NOTED ON ECHOCARDIOGRAM FROM THE PREVIOUS DAY. HOWEVER, IT WAS NOTED TO BE LARGER. THE PATIENT HAD A VENTRICULAR TACHYCARDIA ARREST AND THE FAMILY DECIDED TO MAKE THE PATIENT DO NOT RESUSCITATE. THE PATIENT EXPIRED ON SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391562 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026680149 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death| R