BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 19483330 · Received June 7, 2024

    Report

    Report Number
    1220648-2024-12117
    Event Type
    Death
    Date Received
    June 7, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE REPORTED ISSUES HAS BEEN COMPLETED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. AS THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE THROMBUS AND THE VENTRICULAR FIBRILLATION/VENTRICULAR TACHYCARDIA/ATRIAL FIBRILLATION/ATRIAL TACHYCARDIA WAS NOT DETERMINED. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING ISSUE WAS MOST LIKELY PATIENT MOVEMENT. A FEMOSTOP WAS PLACED TO ADDRESS ACCESS SITE BLEEDING DUE TO THE PATIENT MOVING AS PER THE CLINICAL DESCRIPTION. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12117 AND SHOULD NOT HAVE BEEN. G.1 REVISED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-12117 WAS SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: IMPELLA CP WITH SMART ASSIST SYSTEM SECTION: GENERAL PATIENT CARE CONSIDERATIONS ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ SECTION: ENTERING CARDIAC OUTPUT USE OF THE REPOSITIONING SHEATH AND PEEL-AWAY INTRODUCER ¿REMOVE THE PEEL-AWAY INTRODUCER COMPLETELY FROM THE ARTERY OVER THE CATHETER SHAFT TO PREVENT TRAUMA AND SIGNIFICANT BLEEDING AND APPLY MANUAL PRESSURE ABOVE THE PUNCTURE SITE.¿ 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: IMPELLA CP WITH SMART ASSIST CATHETER INSERTION SECTION: AXILLARY INSERTION OF THE IMPELLA CP WITH SMART ASSIST CATHETER 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.¿ "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."

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 48-YEAR-OLD MALE UNDERGOING CARDIAC SURGERY WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT SUFFERED PULSELESS ELECTRICAL ACTIVITY TWICE. AN ECHOCARDIOGRAM WAS PERFORMED AND A THROMBUS IN THE LEFT VENTRICLE WAS NOTED. A FEM-STOP WAS PLACED TO ADDRESS THE ACCESS SITE BLEEDING DUE TO THE PATIENT MOVING, AND MULTIPLE UNITS OF PACKED RED BLOOD CELLS AND FRESH FROZEN PLASMA WERE TRANSFUSED. THE PATIENT EXPIRED WHILE ON SUPPORT. UPON ABIOMED'S MEDICAL SAFETY OFFICER REVIEW, THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150295 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025458127 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Disability| R| D| L