BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 1102088 · Received August 7, 2008

    Report

    Report Number
    3004742046-2008-00188
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K060817
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED; THEREFORE, DEVICE INVESTIGATION COULD NOT BE PERFORMED. IT WAS POSSIBLE THAT POSITIVE PRESSURE MIGHT HAD OCCURRED DURING DEVICE PREPARATION. AS A RESULT, THE BALLOON MAY HAVE EXPANDED OR PARTIALLY EXPAND, RESULTING IN LOOSENING OF THE STENT AND FACILITATING STENT SEPARATION AS THE PROTECTIVE SHEATH IS REMOVED. THE PRODUCT INSTRUCTIONS FOR USE (IFU) DETAILS THE METHOD OF PREPARATION, WHICH SHOULD PREVENT INADVERTENT INFLATION OF THE BALLOON DURING PREPARATION. DURING PRODUCTION, SAMPLES OF THE STENT DELIVERY SYSTEMS FOR EACH LOT ARE TESTED FOR STENT MOVEMENT DURING ON-LINE RELIABILITY TESTING. IN ADDITION, THE UNITS ARE 100% VISUALLY INSPECTED AND DIMENSIONALLY MEASURED TO ENSURE STENT SECURITY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD REVEALED NO NON-CONFORMITIES FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. NO SPECIFIC ROOT CAUSE WAS IDENTIFIED. ACCORDING TO THE IFU, THE RX HERCULINK ELITE IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT DISLODGED FROM BALLOON. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE:NONE. IT WAS REPORTED THAT DURING A RENAL ARTERY STENTING PROCEDURE, AS THE HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE GUIDE WIRE THROUGH THE GUIDING CATHETER, THE STENT DISLODGED FROM THE BALLOON BUT REMAINED ON THE GUIDE WIRE. THE SDS, GUIDE WIRE, STENT, AND DELIVERY CATHETER WERE REMOVED AS ONE UNIT. 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 RX HERCULINK ELITE STENT SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7021551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK