BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1003575 · Received February 25, 2008

    Report

    Report Number
    3004742046-2008-00044
    Event Type
    Injury
    Date Received
    February 25, 2008
    Report Date
    February 1, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K021824
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO POSITION. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: STENT DEPLOYED IN UNINTENDED SITE. IT WAS REPORTED THAT DURING AN AV FISTULA STENTING PROCEDURE WHILE ADVANCING THE ABSOLUTE STENT OVER A GUIDE WIRE, THE STENT SYSTEM WOULD NOT CONTINUE TO MOVE FORWARD. ATTEMPTS WERE MADE TO ADVANCE THE DEVICE, RESULTING IN THE STENT DEPLOYING IN AN UNINTENDED SITE. A COMPETITOR STENT WAS REQUIRED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM 78FGE FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7121151

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention TERMO GLIDEWIRE