BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1040639 · Received May 8, 2008

    Report

    Report Number
    2953144-2008-00861
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE #2 - XCEED (LOT 51081-6H), REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: (DEVICE #1) PREMATURE PARTIAL DEPLOYMENT. TIME OF DEVICE MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE FIRST XCEED STENT WAS BEING DEPLOYED AT THE INTENDED SITE WHEN THE DEPLOYMENT THUMB KNOB FROZE AND WOULD NOT TURN. FORCE WAS APPLIED IN THE ATTEMPT TO DEPLOY THE STENT RESULTING IN THE THUMB KNOB SPINNING FREELY. THE STENT WAS REMOVED AS ONE UNIT. A SECOND XCEED STENT WAS ADVANCED TO THE LESION AND DURING ATTEMPTED DEPLOYMENT OF THE STENT, THE KNOB WOULD NOT TURN AND USING FORCE THE SHAFT COMPLETELY SPLIT AND BROKE AWAY FROM THE HANDLE RESULTING IN THE KNOB SPINNING FREELY. THE DEVICE WAS REMOVED WITHOUT MEDICAL OR SURGICAL INTERVENTION. NO PARTIAL STENT DEPLOYMENT WAS REPORTED. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    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 50071-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR (LOT# 51081-6H)| STENT: DEVICE #2 - XCEED