BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFESTENT FLEXSTAR BILIARY STENT SYSTEM

    MDR report key: 871925 · Received June 5, 2007

    Report

    Report Number
    6000002-2007-01040
    Event Type
    Death
    Date Received
    June 5, 2007
    Date of Event
    May 4, 2007
    Report Date
    May 7, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DURING THE PRE DECO EXAM, THE GUIDEWIRE LUMEN APPEARS TO HAVE BROKEN INSIDE THE OUTER BODY TUBE. THERE IS ABOUT 28.5" OF THE GW LUMEN THAT HAS DETACHED. THERE ARE SEVERAL SEVERE KINKS THROUGH OUT THE LENGTH OF THE GW LUMEN ALONG WITH WHAT APPEARS TO BE DRIED BLOOD INSIDE THE GW LUMEN. POST DECO EXAM, THE HANDLE WAS OPENED AND THE PUSHER WAS FOUND TO BE DETACHED FROM THE HYPOTUBE BY ABOUT 7MM. THERE APPEARS TO BE SOME STRETCHING OF THE GW LUMEN AT THE HYPOTUBE. THE OD IS 0.039" AT THE HYPOTUBE AND 0.044" AT THE TIP AND 0.042" AT THE BREAK SITE. THERE IS A MARK ON THE OUTER BODY 9.6" DISTAL OF THE STRAIN RELIEF. (PLEASE SEE SCANNED PAGES).

    Description of Event or Problem · 1

    REPORTEDLY AFTER IMPLANT, THE DELIVERY SYSTEM COULD NOT BE PULLED BACK OVER THE GUIDEWIRE AFTER THE STENT WAS IMPLANTED. AFTER SEVERAL ATTEMPTS, PARTS OF THE INNER SHEATH SEEMED TO HAVE RIPPED OFF AND THE SYSTEM COULD BE RETRACTED. THE INNER PART OF THE SYSTEM REMAINED IN THE PATIENT ON THE GUIDEWIRE. THE DOCTOR TRIED TO RETRIEVE IT WITH A GUIDE CATHETER AND REMOVED THE .035 GUIDEWIRE. AFTER THE CATHETER WAS REMOVED, HE REMOVED THE MISSING PIECE. STENT REGION OCCLUDED, NO DILATION NO SUCCESS. PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR BILIARY STENT SYSTEM BILIARY STENT FGE EDWARDS LIFESCIENCES EX60803C R58272206

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death| R