BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23603641 · Received November 20, 2025

    Report

    Report Number
    1220648-2025-48493
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    0081350201334
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR INVESTIGATION. HEMATOMA: BIG HEMATOMA AS BEFORE, LITTLE BIT OF PERICARDIAL EFFUSION. THE CAUSE OF THE HEMATOMA WAS UNABLE TO BE DETERMINED AS INSUFFICIENT CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR ANALYSIS. PERICARDIAL EFFUSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1990598. DEVICE HISTORY BATCH SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT HAD AN IMPELLA CP PLACED TO SUPPORT A PATIENT ADMITTED IN WITH KNOWN CARDIAC HISTORY. THE PUMP WAS PLACED BUT THE SINGLE ACCESS SITE HAD A HEMATOMA AND A LITTLE BIT OF PERICARDIAL EFFUSION WHILE ON SUPPORT. THE PUMP WAS EXPLANTED AND THE PATIENT SURVIVED. ADDITIONAL INFORMATION WAS RECEIVED. THE HEMATOMA WAS NOT AT THE GROIN. IT WAS A HEMATOMA DUE TO PERCUTANEOUS CORONARY INTERVENTION OF A VENOUS GRAFT FROM A CORONARY ARTERY GRAFT OUT OF 1997. THE HEMATOMA WAS IN THE RIGHT VENTRICLE MYOCARDIAL WALL AND WAS NOT RELATED TO THE IMPELLA BUT TO THE PERCUTANEOUS CORONARY INTERVENTION. THE IMPELLA PUMP WAS NOT COLLECTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468206 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026755293 0081350201334

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention