BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE STENT

    MDR report key: 5404961 · Received January 16, 2004

    Report

    Report Number
    2134479-2003-00009
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Date of Event
    December 4, 2003
    Report Date
    January 9, 2004
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THIS IS THE SECOND STENT USED IN THE SAME PROCEDURE. SECOND STENT WAS DELIVERED, AND STILL WOULD NOT CROSS LESION, DEPLOYED PROXIMAL TO LESION. PHYSICIAN NOTICED HIGHLY STENOTIC LESION, MID-STENT WHICH WOULD NOT ALLOW STENT TO EXPAND. PHYSICIAN THEN ATTEMPTED TO REMOVE PROTEGE CATHETER, HOWEVER, IT WOULD NOT MOVE. HE SAID, "IT WAS CAUGHT ON THE CALCIUM THROUGHOUT THE SFA." PHYSICIAN CONTINUED TO MANIPULATE THE CATHETER WAS CAUGHT ON EITHER CALCIUM OR PORTION OF STENT WHICH WOULD NOT EXPAND. THE PHYSICIAN NOTICED THAT THE DISTAL 10CM OF THE CATHETER WAS STRETCHING BECAUSE THE TIP COULD NOT BE RELEASED FROM THE CALCIUM. EVENTUALLY, THE CATHETER BROKE AT THE PROXIMAL RADIOPAQUE MARKER SITE. REMAINING PORTION OF THE CATHETER WAS REMOVED. RADIOPAQUE MARKER WAS HUNG UP IN THE STENT ADN LEFT IN THE BODY. THE PHYSICIAN BELIEVES THE TIP OF THE CATHETER WAS ALSO LEFT IN THE BODY. AT THIS TIME THE PHYSICIAN PULLED WIRE AND CONSULTED SURGEON. THE SURGEON DECLINED TO TAKE A PATIENT TO SURGERY, BECAUSE THIS WAS A LEG SALVAGE CASE ADN THE PATIENT WAS GOING TO BE AMPUTATED IN THE NEAR FUTURE. THE PATIENT DIED 5 DAYS LATER FROM RENAL FAILURE. DIALYSIS WAS STOPPED BEFORE (B)(6). PATIENT DECEASED UNRELATED TO PROCEDURE AS REPORT BY EV3 TERRITORY MANAGER FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT BILIARY STENT SYSTEM FGE EV3 INC SE-6150-120 215818

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK