BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 18826238 · Received March 4, 2024

    Report

    Report Number
    1220648-2024-07325
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    February 23, 2024
    Report Date
    April 4, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: MAINTAINING ACT AT OR ABOVE 250 SECONDS WILL HELP PREVENT A THROMBUS FROM ENTERING THE CATHETER AND CAUSING A SUDDEN STOP ON STARTUP.¿ ¿UNRESOLVED PURGE PRESSURE HIGH ALARM IF NOT RESOLVED BY THE RECOMMENDATIONS PROVIDED, HIGH PURGE PRESSURE¿WHICH TRIGGERS THE ¿PURGE PRESSURE HIGH¿ ALARM MESSAGE¿COULD BE AN INDICATION OF A KINK IN THE IMPELLA CATHETER. IN THIS CASE, THE MOTOR IS NO LONGER BEING PURGED AND MAY EVENTUALLY STOP.¿ ¿IMPELLA STOPPED IF THE IMPELLA CATHETER HAS STOPPED SUDDENLY: 1. TRY TO RESTART THE CATHETER AT PREVIOUS P-LEVEL. 2. IF THE IMPELLA DOES NOT RESTART, TRY TO RESTART AT P-2. 3. IF THE IMPELLA DOES NOT RESTART OR STOPS AGAIN, WAIT 1 MINUTE AND TRY TO RESTART AGAIN. 4. IF THE IMPELLA RESTARTS, WEAN DOWN TO P-2 AS THE PATIENT CAN TOLERATE. UNDER THESE CIRCUMSTANCES, CATHETER FUNCTION IS NOT RELIABLE AND THE IMPELLA MAY STOP AGAIN. 5. IF THE IMPELLA DOES NOT RESTART, REMOVE THE IMPELLA FROM THE VENTRICLE AS SOON AS POSSIBLE TO AVOID AORTIC INSUFFICIENCY.¿ ¿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 VASCULAR INJURY.¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE ACCESS SITE BLEEDING ¿ MAJOR ISSUE HAS BEEN COMPLETED SINCE THE INITIAL REPORT WAS SUBMITTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING WAS MOST LIKELY DUE TO ANTICOAGULATION MANAGEMENT SINCE THE ACT AT THE TIME OF BLEED AND END WAS 233, WHICH IS ABOVE THE LIMIT RANGE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 52-YEAR-OLD MALE IN ST ELEVATED MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE DECISION WAS MADE TO REMOVE THE IMPELLA CP DUE TO BLEEDING SIGNIFICANTLY FROM THE ACCESS SITE. FIVE UNITS OF PACKED RED BLOOD CELLS WAS TRANSFUSED AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661153 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024422803 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention