BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 22029921 · Received May 15, 2025

    Report

    Report Number
    1220648-2025-28458
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 25, 2025
    Report Date
    May 15, 2025
    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

    A4 IS UNKNOWN. 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 MDR WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: THE INSTRUCTIONS FOR USE FOR THE IMPELLA CP WITH SMART ASSIST SYSTEM STATES THE FOLLOWING: 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).¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED INTERNAL BLEEDING IN THEIR IEG LEADING TO DEVELOPMENT OF A HEMATOMA. THE LEG WAS SWOLLEN AND A CT SCAN VERIFIED AN ACTIVE BLEED. TWO UNITS OF BLOOD WERE GIVEN AND THE PUMP WAS EXPLANTED IN RESPONSE TO THE CONDITION. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88774 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC IMPELLA CP 2025547445 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention