BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1071365 · Received July 8, 2008

    Report

    Report Number
    3004742046-2008-00166
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 18, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ABSOLUTE CATHETER WAS RETURNED WITH THE STENT PARTIALLY DEPLOYED BY 1.9 CM. BOTH THE DISTAL OUTER MEMBER SHEATH AND THE GEAR RACK (WITHIN THE HANDLE) WERE RETRACTED 2.0 CM, WHICH WOULD BE EXPECTED WHEN ATTEMPTING TO DEPLOY THE STENT. THERE WERE TWO KINKS IN THE SHAFT THAT PENETRATED THE OUTER MEMBER AND INNER BRAIDED MEMBER DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO REPORT OF ANY KINK OBSERVED DURING DEVICE PREPARATION. KINKS CAN CAUSE DEPLOYMENT DIFFICULTIES IF USED IN A TORTUOUS PART OF THE ANATOMY. DURING INVESTIGATION THE THUMBWHEEL WAS ROTATED AND THE STENT WAS DEPLOYED WITHOUT RESISTANCE. THERE WAS NO DAMAGE NOTED TO THE STENT. A SPECIFIC ROOT CAUSE FOR THE KINKS AND PARTIAL DEPLOYMENT COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIALS REPORTS, WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: THUMBWHEEL DID NOT TURN; PARTIAL STENT DEPLOYMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN ILIAC STENTING PROCEDURE, AFTER PRE-DILATATION WAS PERFORMED AND DURING STENT DEPLOYMENT, THE ABSOLUTE STENT WAS DEPLOYED BY 1 CM WHEN THE THUMBWHEEL WOULD NOT TURN ANY FURTHER AND THE STENT COULD NOT BE FULLY DEPLOYED. THE STENT AND DELIVERY SYSTEM WERE REMOVED WITHOUT DIFFICULTY AND THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT STENT. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADDITIONAL 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 6012051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK