BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 589484 · Received April 7, 2005

    Report

    Report Number
    3004742046-2005-00023
    Event Type
    Injury
    Date Received
    April 7, 2005
    Date of Event
    March 11, 2005
    Report Date
    March 11, 2005
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CROSSOVER ACCESS TECHNIQUE WAS BEING PERFORMED IN ORDER TO RELEASE THE STENT. THE STENT DELIVERY SYSTEM HAD AN INVINCIBLE RESISTANCE THAT DEVELOPED, CAUSING THE STENT TO REMAIN IN THE SHAFT. THE STENT WAS PULLED ON AND THEN IT WAS RELEASED. DILATATION WAS PERFORMED AND THE STENT WAS COMPRESSED AGAINST THE VASCULAR WALL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE GUIDANT ENDOVASCULAR SOLUTIONS NA 4102151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention| S