BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EV-3 STENT

    MDR report key: 1210970 · Received October 23, 2008

    Report

    Report Number
    MW5008756
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 23, 2008
    Manufacturer
    EV-3 THE ENDOVASCULAR COMPANY
    Product Code
    NIN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNDEPLOYED RENAL STENT SEPARATED FROM BALLOON/CATHETER. ALL SECTIONS OF DEVICE RETRIEVED AND REMOVED FROM BODY. PROCEDURE TIME EXTENDED, FAILURE TO PLACE SENT TO RIGHT RENAL ARTERY. PT SENT TO RECOVERY WITHOUT SUCCESSFUL COMPLETION OF STENT PLACEMENT IN RIGHT RENAL ARTERY. PT WITH PERIPHERAL VASCULAR DISEASE WILL REQUIRE ANOTHER INTERVENTION PROCEDURE AND DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EV-3 STENT PARAMOUNT MNI GPS NIN EV-3 THE ENDOVASCULAR COMPANY PMB4-5-18-80 5853006
    2 EV-3 STENT PARAMOUNT MINI GPS NIN EV-3 THE ENDOVASCULAR COMPANY 5283629

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability