BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP FLEX

    MDR report key: 21708444 · Received March 27, 2025

    Report

    Report Number
    1220648-2025-26997
    Event Type
    Death
    Date Received
    March 27, 2025
    Date of Event
    February 2, 2025
    Report Date
    March 27, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WITH AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK IMPLANTED WITH AN IMPELLA RP FLEX DEVICE EXPERIENCED HEMOLYSIS AND WOULD LATER EXPIRE. THE PATIENT WAS ADMITTED IN WITH RIGHT VENTRICULAR DYSFUNCTION. THE IMPELLA RP FLEX WAS IMPLANTED, THE PATIENT WAS PLACED ON CONTINUOUS RENAL REPLACEMENT THERAPY AND WAS SUBSEQUENTLY TRANSFERRED TO THE TERTIARY CENTER FOR CARE. AFTER APPROXIMATELY FOUR DAYS ON SUPPORT, THE PATIENT STARTED HAVING PINK-TINGED URINE AND LABS CAME BACK HEMOLYZED; A CHEST X-RAY THE FOLLOWING DAY CONFIRMED GOOD IMPELLA RP FLEX PLACEMENT. HOWEVER, THE HEMOLYSIS EVENT WAS NOT RESOLVED. THE FOLLOWING DAY IMPELLA ALARMING PURGE SYSTEM BLOCKED; ECHOCARDIOGRAM SHOWED SOME IMPROVEMENT TO RIGHT VENTRICLE. HOWEVER, THE DECISION WAS MADE TO REMOVE THE DEVICE AND THE PATIENT EXPIRED. FURTHER DETAILS SURROUNDING THE EVENT INCLUDING TREATMENT FOR THE HEMOLYSIS ALONG WITH THE CAUSE OF DEATH ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433075 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025578207 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention| D