BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1160020 · Received September 12, 2008

    Report

    Report Number
    2953144-2008-01480
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    FGE
    PMA / PMN Number
    K050103
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VASCULAR USE. THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SHAFT SEPARATION. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE XPERT STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION. STRONG RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE STENT DELIVERY SYSTEM (SDS). STRONG FORCE WAS USED TO PULL THE SDS THROUGH THE SHEATH. THE SHAFT SEPARATED WHILE EXITING THE SHEATH, LEAVING APPROXIMATELY 40 CM REMAINING INSIDE THE DISTAL END OF THE SHEATH. THE DETACHED PORTION OF THE SHAFT WAS MANUALLY REMOVED FROM THE SHEATH WITHOUT DIFFICULTY. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM FGE ABBOTT VASCULAR REDWOOD CITY NA 62004-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK