BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2595455 · Received May 30, 2012

    Report

    Report Number
    3005325609-2012-00014
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 14, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE IS TO BE RETURNED AND AN MDR SUPPLEMENT WILL BE SUBMITTED FOLLOWING DEVICE ANALYSIS.

    Description of Event or Problem · 1

    A 5X200MM SUPERA STENT WAS BEING DEPLOYED IPSILATERALLY INTO THE RIGHT SFA. THE VESSEL WAS PREPPED WITH A 5MM STENT BALLOON. THE PHYSICIAN PERFORMED THE FINAL RELEASE OF THE STENT, RETRACTED THE STENT, AND THEN HEARD A CLICK WHILE RETRACTING THE DEVICE. THE PROXIMAL PORTION OF THE STENT REMAINED ATTACHED TO THE CATHETER AND WAS STRETCHED AS THE SYSTEM WAS RETRACTED. THE PHYSICIAN MANIPULATED (PULLING AND ROTATING) THE DELIVERY SYSTEM TO RELEASE THE STENT. WHILE ATTEMPTING TO REMOVE THE CATHETER, THE PHYSICIAN NOTICED THAT THE TIP HAD BECOME DETACHED AND WAS VISIBLE WITHIN THE PROXIMAL EXTREMITY OF THE STENT. THE PHYSICIAN WAS ABLE TO MANIPULATE THE TIP INTO THE SHEATH USING A BALLOON CATHETER. THE SHEATH WITH THE TIP WAS THEN REMOVED. THE SFA AND PROFUNDA APPEARED TO BE PT PER THE FINAL IMAGES. IT WAS REPORTED THAT THERE WAS NO EFFECT TO THE PT. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-200-120-6F 01137064

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention