BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 692230 · Received March 24, 2006

    Report

    Report Number
    3004742046-2006-00129
    Event Type
    Malfunction
    Date Received
    March 24, 2006
    Report Date
    February 23, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS ATTEMPTING TO DEPLOY AN ABSOLUTE STENT DELIVERY SYSTEM IN THE SFA (OFF-LABEL USE). THE DOCTOR DEPLOYED HALF OF THE STENT, AND THEN THE THUMBWHEEL BECAME STUCK. THE DOCTOR PULLED THE STENT BACK IN THE SHEATH AND REMOVED THE ABSOLUTE FROM THE PT. THERE WAS NHO REPORTED INJURY AND NO ADDITIONAL INFO. AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM MAF GUIDANT ENDOVASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN