BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 19085650 · Received April 10, 2024

    Report

    Report Number
    1220648-2024-09739
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 11, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ABIOMED, INC
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS ALREADY BEEN CAPTURED AND REPORTED UNDER MDR REPORT #1220648-2024-09738. THEREFORE, THE INITIAL MDR 1220648-2024-09739 IS CONSIDERED A DUPLICATE OF MDR REPORT #1220648-2024-09738. NO FURTHER SUPPLEMENTAL REPORTS WILL BE SENT UNDER 1220648-2024-09739.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT WAS IMPLANTED WITH AN IMPELLA RP FLEX PUMP FOR MECHANICAL CIRCULATORY SUPPORT. DURING THE COURSE OF SUPPORT, THE PATIENT SUFFERED FROM A THROMBOEMBOLIC STROKE. SYSTEMIC HEPARIN WAS HALTED PER NEURO RECOMMENDATION TO PREVENT CONVERSION. PLANS WERE MADE TO WEAN THE PATIENT OFF THE PUMP AS TOLERATED FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695118 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC RP FLEX W SMART ASSIST SET, US 2024435349 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention