BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 20014399 · Received August 21, 2024

    Report

    Report Number
    1220648-2024-15476
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    October 29, 2021
    Report Date
    August 16, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 IFU: IMPELLA CP WITH SMARTASSIST 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).¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT HAD SIGNIFICANT BLEEDING/OOZING AT BLUE HUB AND NOTICED IT WAS ON THE SKIN. THE STERILE SLEEVE WAS NOT LOCKED. ECHO WAS PERFORMED AND SHOWED IT BE 2.5CM. CONTINUOUS SUCTION ALARMS PERSISTED WHILE HOLDING PRESSURE. THE PATIENT BECAME DIAPHORETIC AND HYPOTENSIVE. THE PATIENT WAS TAKEN BACK TO LAB FOR PUMP REMOVAL DUE TO VASCULAR COMPLICATION. AT REMOVAL, TWO PERCLOSE WERE DEPLOYED, MANUAL PRESSURE WAS HELD FOR 30MIN AND FEM-STOP WAS APPLIED. AN INTRA-AORTIC BALLOON PUMP WAS PLACED ON LEFT SIDE. THE PATIENTS SYSTOLIC BLOOD PRESSURE WAS IN THE 40S. THE PATIENT WAS STARTED ON PRESSORS AND TAKEN BACK TO CRITICAL CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045199 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2022104839 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention