BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 18081208 · Received November 6, 2023

    Report

    Report Number
    1220648-2023-04818
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    October 7, 2023
    Report Date
    February 21, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011944
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ ¿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.¿ ¿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 REPORTED ACCESS SITE BLEEDING HAS BEEN COMPLETED SINCE THE ORIGINAL REPORT WAS FILED. PUMP WAS NOT RETURNED FOR INVESTIGATION. THE CAUSE OF THE ACCESS SITE BLEEDING ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND SUFFICIENT CLINICAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED A 46-YEAR-OLD MALE NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT IN MEDICOVER HOSPITAL IN INDIA. THE PATIENT HAD ACCESS SITE BLEEDING AND A HEMATOMA. THE IMPELLA CP WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297729 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP - APAC 2024345187 00813502011944

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention