BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1051563 · Received May 19, 2008

    Report

    Report Number
    3004742046-2008-00113
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K021824
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OFF LABEL USE IN THE SUPERFICIAL FEMORAL ARTERY). THE ABSOLUTE CATHETER WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE SHAFT AND BLOOD VISIBLE ON THE HANDLE. THE STENT WAS NOT RETURNED. THE DISTAL OUTER MEMBER (RETRACTABLE SHEATH) WAS RETRACTED PROXIMAL TO THE TIP. THE RACK, WITHIN THE HANDLE, WAS FULLY RETRACTED. THERE WERE A TOTAL OF THREE KINKS IN THE CATHETER. THERE WERE TWO KINKS IN THE SHAFT THAT PENETRATED THE OUTER MEMBER AND INNER BRAIDED MEMBER DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS A KINK IN THE SENT HOLDER PROXIMAL TO THE TIP. THERE WERE CHATTERMARKS IN THE SHAFT DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE CATHETER. THE HANDLE WAS IN THE UNLOCKED POSITION. THE HANDLE WAS OPENED AND THE RACK WAS OBSERVED IN THE PROXIMAL POSITION, RETRACTED. ALL THE INTERNAL MECHANISMS WERE INTACT WITH NO ANOMALIES NOTED. ATTEMPTS TO REPOSITION THE RACK IN THE DISTAL POSITION WERE UNSUCCESSFUL DUE TO THE DRIED BLOOD AND CONTRAST IN THE SHAFT LUMEN. THE KINKS AND CHATTER MARK (MINI KINKS) CAN RESTRICT THE RETRACTION OF THE RETRACTABLE SHEAT. THE KINKS APPEAR TO BE PROCEDURE RELATED. A CONCLUSIVE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED, HOWEVER, IT DOES NOT APPEAR TO BE RELATED TO A QUALITY ISSUE. PRODUCTION HAS MULTIPLE OPERATIONS THAT INSPECT 100% FOR SHAFT DAMAGE PRIOR TO PACKAGING. PRODUCTION ALSO INSPECTS 100% THE THUMBWHEEL ROTATION AND THE RETRACTABLE SHEATH MOVEMENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: THUMBWHEEL LOCKED, PARTIAL STENT DEPLOYMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT THE ABSOLUTE STENT DELIVERY SYSTEM POSITIONED FOR DEPLOYMENT IN THE SUPERFICIAL FEMORAL ARTERY, VIA A CONTRALATERAL APPROACH; HOWEVER, THE THUMBWHEEL LOCKED AND IT APPEARED ON FLUORO THAT THE STENT DID NOT DEPLOY. AFTER THE STENT DELIVERY SYSTEM WAS REMOVED IT WAS OBSERVED THAT THE STENT WAS PARTIALLY DEPLOYED. THERE WAS NO ADVERSE PT EFFECT. AFTER USE THE DEVICE WAS MANIPULATED AND THE STENT WAS INTENTIONALLY DEPLOYED WITHOUT A PROBLEM. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    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 6100951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK