BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX HERCULINK ELITE

    MDR report key: 1941605 · Received December 17, 2010

    Report

    Report Number
    1941605
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ABBOTT
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A PROCEDURE FOR STENT PLACEMENT WAS PERFORMED ON THE RIGHT RENAL ARTERY. THE STENT SLIPPED OFF OF THE DELIVERY BALLOON PRIOR TO THE PROPER PLACEMENT OF THE STENT. EVENTUALLY IT WAS PULLED DOWN TO THE RIGHT FEMORAL VESSEL. PER THE MD, THE STENT WAS EXPANDED IN THE PROFUNDA AND POSES NO RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK ELITE BILIARY STENT SYSTEM FGE ABBOTT * 0040151

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR