BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 21494003 · Received February 28, 2025

    Report

    Report Number
    1220648-2025-26435
    Event Type
    Death
    Date Received
    February 28, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 19, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF ACCESS SITE BLEEDING HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING WAS MOST LIKELY PATIENT MOVEMENT SINCE THE HEMATOMA OCCURRED AFTER THE PATIENT WAS TRANSPORTED FROM THE CATHETERIZATION LABORATORY TO THE INTENSIVE CARE UNIT. B.2 ADDED DEATH AND DATE OF DEATH AS THEY WERE INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26435. B.7 ADDED INFORMATION AS IT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26435. E.1 REVISED ADDRESS LINE 1 AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26435. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26435 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26435 AND SHOULD NOT HAVE BEEN. G.1 ADDED REPORTING CONTACT ADDRESS LINE 1, US CITY, STATE, COUNTRY AND US ZIP CODE AS THEY WERE INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26435. H.6 HEALTH EFFECT IMPACT CLINICAL CODE 1888 WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26435 AND A NEW CODE WAS ADDED.

    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).¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT EXPERIENCED HEMATOMA WITH A HEMOGLOBIN DECREASE. IMPELLA WAS REMOVED AND THE PUNCTURE SITE WAS CLOSED WITH A PROGLIDE AND AN ANGIOSEAL AND A PRESSURE BANDAGE WAS APPLIED. BLOOD UNITS WERE ORDERED. PATIENT WAS STABLE. ADDITIONAL INFORMATION NOTED CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031369 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025596822

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| D AUTOMATED IMPELLA CONTROLLER