BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1161548 · Received September 15, 2008

    Report

    Report Number
    2953144-2008-01492
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 27, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT DEVICE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SDS HANDLE SEPARATED. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, DURING ATTEMPTED STENT DEPLOYMENT, THE HANDLE ON THE XCEED STENT DELIVERY SYSTEM (SDS) SEPARATED INTO TWO PIECES. THE STENT DID NOT DEPLOY. THE SDS WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED USING A SECOND XCEED STENT. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFO 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 58015-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK