BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 20766903 · Received November 23, 2024

    Report

    Report Number
    1220648-2024-24063
    Event Type
    Injury
    Date Received
    November 23, 2024
    Date of Event
    June 13, 2024
    Report Date
    January 2, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS BEEN DISCARDED BY THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE STATE THE FOLLOWING: IMPELLA CP WITH SMART ASSIST 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).¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED ACCESS SITE BLEED HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE ACCESS SITE BLEED COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE PROTECT IV STUDY THAT THE PATIENT ON IMPELLA CP SUPPORT DEVELOPED RIGHT GROIN HEMATOMA AND TRANSFUSION WAS GIVEN. ADDITIONALLY, THERE WAS A DECREASE IN HEMOGLOBIN FROM BASELINE. THE PATIENT UNDERWENT COMPLEX PERCUTANEOUS CORONARY INTERVENTION THROUGH RIGHT GROIN WITH IMPELLA PLACEMENT FOR HEMODYNAMIC SUPPORT. AFTER THE PROCEDURE IT WAS NOTED A RIGHT GROIN HEMATOMA. IT WAS STABLE UNTIL IMPELLA REMOVAL ON (B)(6) 2024 WHEN IT APPEARED TO SLIGHTLY INCREASE IN SIZE; PERIPHERAL PULSES REMAINED PALPABLE ALTHOUGH SOME ECCHYMOSIS WAS NOTED. THIS EVENT LIKELY CONTRIBUTED TO THE DECREASE HEMOGLOBIN FROM BASELINE FOR WHICH TWO TRANSFUSIONS WERE PERFORMED. HEMATOMA WAS DEEMED TO BE RESOLVED PRIOR TO DISCHARGE ON (B)(6) 2024. PATIENT BASELINE HEMOGLOBIN WAS ALREADY LOW. HOWEVER, AFTER INDEX PROCEDURE IT STARTED TO DECREASE REACHING 7.6 G/DL ON (B)(6) 2024 (REQUIRING TRANSFUSION 1 UNIT ON (B)(6) 2024 ACCOMPLISHED A HEMOGLOBIN OF 9.2 G/DL) AND 7.7 G/DL ON (B)(6) 2024 ALSO REQUIRING TRANSFUSION (1 UNIT AND REACHING 8.8 G/DL). PATIENT HEMOGLOBIN WAS NOTED TO BE 9.7 G/DL AT DISCHARGE. ON, (B)(6) 2024 HEMOGLOBIN WAS FOUND TO BE 12.9 G/DL WHICH IS CLOSER TO THE BASELINE VALUE. THE PATIENT SURVIVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798369 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025488394 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention