BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 20056858 · Received August 23, 2024

    Report

    Report Number
    1220648-2024-16310
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    January 17, 2022
    Report Date
    October 13, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: 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.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN IDENTIFIED AS A PART OF RETROSPECTIVE REVIEW. DUE TO LIMITED CLINICAL INFORMATION AND LACK OF AVAILABLE DATA/PRODUCT, THE ROOT CAUSE OF THIS INVESTIGATION IS NOT DETERMINED. E4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT IN ACCORDANCE WITH UPDATED PROCEDURES.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT THE PATIENT HAD BLEEDING AND LOW FLOWS. THE PATIENT DETERIORATED AND BLED FROM OROGASTRIC TUBE. ONE UNIT OF RED BLOOD CELL PRODUCTS WERE GIVEN. THE PUMP FLOW ALSO REMAINED LOW AND SUCTION ALARMS PRESENT PASSED P3. AN ECHOCARDIOGRAM DONE AT BEDSIDE. LEFT VENTRICLE SHOWED THERE IS NO VOLUME. FAMILY DECIDED TO WITHDRAW CARE. MEDICAL SAFETY REVIEW OF THE EVENT NOTE USE OF THE DEVICE CANNOT CONCLUSIVELY BE ASSOCIATED WITH THE OUTCOME (PATIENT'S DEMISE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287064 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2022148256 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention