BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 18251020 · Received December 1, 2023

    Report

    Report Number
    1220648-2023-05198
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 26, 2023
    Report Date
    February 22, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE REPORTED LIMB ISCHEMIA ¿ REVERSIBLE BEEN COMPLETED SINCE THE ORIGINAL REPORT WAS FILED. AS THE NECESSARY CLINICAL INFORMATION WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED, THE ROOT CAUSE OF THE LIMB ISCHEMIA WAS NOT DETERMINED.

    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: ¿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.¿

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A MALE PATIENT HWO HAD VENTRICULAR FIBRILLATION AND ARREST IN THE FIELD WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. ADDITIONALLY, THE PATIENT WAS SUPPORTED BY VA-ECMO. THE COMPLAINANT REPORTED THAT THE PATIENT HAD A COLD LEG WITH POOR DISTAL PERFUSION. IN ORDER TO IMPROVE FLOW LEFT FEMORAL EXTERNAL BYPASS WITH TWO 6FR SHEATHS PROCEDURE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634338 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PUMP 380 14F LT CMR SET (US) 2024347700 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Required Intervention