BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1080595 · Received July 22, 2008

    Report

    Report Number
    3004742046-2008-00173
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 21, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. ANGIOGRAPHIC IMAGES WERE NOT SUBMITTED TO ABBOTT VASCULAR FOR FAILURE MODE ANALYSIS AND CONFIRMATION. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. IT IS POSSIBLE THAT THE STENT WAS NOT FRACTURED. THE FRACTURE APPEARANCE IS WELL EXPLAINED BY THE OPEN-CELL DESIGN OF THE ABSOLUTE STENT, IN COMBINATION WITH LESION CHARACTERISTICS. THE CONCLUSIVE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. ALL STENTS ARE 100% INSPECTED VISUALLY AND DIMENSIONALLY AND ALL STENTS ARE 100% RADIAL FORCE TESTED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT DAMAGE AND FRACTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE RIGHT LOWER EXTREMITY, DAMAGE AND FRACTURE WAS OBSERVED IN THE ABSOLUTE STENT. NO ADVERSE PATIENT EFFECT WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8022551

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR