BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 18569626 · Received January 24, 2024

    Report

    Report Number
    1220648-2024-06241
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    January 10, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ABIOMEND, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: ACCESS SITE BLEEDING: 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 ISCHEMIA: 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 ACCESS SITE BLEEDING AND LIMB ISCHEMIA HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. THE FOLLOWING HAVE BEEN REPORTED INCORRECTLY OR MISSING FROM MANUFACTURER DEVICE REPORT 1220648-2024-06241. D6A AND D6B REVISED FROM THE INITIAL SUBMISSION IN ACCORDANCE WITH UPDATED PROCEDURES. F6/F8-SHOULD HAVE BEEN LEFT BLANK. G1 REPORTING CONTACT EMAIL.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 63-YEAR-OLD FEMALE IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT ONE DAY FOLLOWING IMPLANT, THE PATIENT'S LEG WAS COLD TO THE TOUCH AND A FEM-FEM BYPASS WAS PERFORMED TO IMPROVE THE FLOW. DURING THE DRESSING CHANGE OF INSERTION SITE, THE ANGLE OF INSERTION WAS NOT MAINTAINED, AND A HEMATOMA DEVELOPED. THE PATIENT WAS PROVIDED ONE UNIT OF FRESH FROZEN PLASMA (FFP) AND TWO UNITS OF PACKED RED BLOOD CELLS AS TREATMENT. THE PATIENT REMAINED ON SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900112 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMEND, INC. IMPELLA CP 2024422862 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention FEM-FEM BYPASS