BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    MDR report key: 2771918 · Received September 28, 2012

    Report

    Report Number
    1820334-2012-00436
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K051124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETRIEVAL OF DEVICE IS NOT LABELED. SEPARATION IS LABELED. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO STENT A SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS HIGHLY CALCIFIED. DURING DEPLOYMENT, THE STENT SHEATH SEPARATED. HOWEVER THE AREA THE AREA OF SEPARATION WAS NOT INSIDE THE VESSEL (OUTSIDE OF SHEATH). THE DOCTOR PERFORMED AN ANGIOPLASTY WITH A 5MM X 200MM 018EV3. UNSHEATHED THE STENT BY PULLING THE INNER CATHETER PORTION OF THE DELIVERY SYSTEM AS THE FLEXOR SHEATH MATERIAL WAS BROKEN. AN ADD'L PROCEDURE WAS UNSUCCESSFULLY ATTEMPTED WITH ANOTHER ZILVER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC NA 3346496

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention