BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1191903 · Received October 1, 2008

    Report

    Report Number
    2953144-2008-01611
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OFF LABEL, VASCULAR USE). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE PERCLOSE AT (PART 12337-04, LOT 59203-6H) IS BEING FILED ON A SEPARATE MEDWATCH.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT DELIVERY SYSTEM DETACHMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT AN XCEED STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT POPLITEAL ARTERY. DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS), THE RADIOPAQUE TIP SEPARATED FROM THE HYPOTUBE SHAFT BUT REMAINED ON THE GUIDE WIRE IN THE BODY. THE DETACHED TIP WAS COMPLETELY REMOVED WITHIN THE SHEATH. THERE WAS NO ADVERSE PT EFFECT. RIGHT FEMORAL ARTERIOTOMY CLOSURE WAS ATTEMPTED USING A PERCLOSE AT. WHEN ATTEMPTING TO DEPLOY THE DEVICE "BOTH SUTURES WERE CUT". THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADD'L 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 45137-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR TERUMO 6.5F SHEATH| PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEM| NON-ABBOTT .035 X 300 CM GUIDE WIRE