BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2572547 · Received May 8, 2012

    Report

    Report Number
    3005325609-2012-00012
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: VISUAL EXAMINATION UNDER MAGNIFICATION CONCLUDED THAT THE LUMEN HAD SEPARATED FROM THE DISTAL END OF THE RATCHET STEM. ANGIOGRAMS WERE RECEIVED BUT ONLY SHOWED THE FINAL IMAGES FOLLOWING STENT DEPLOYMENT. ADD'L ANGIOGRAMS OF THE PROCEDURE HAVE BEEN REQUESTED. BECAUSE THE STENT IMPLANTED WAS LONGER THAN DESIRED (40 MM), IT IS CONCLUDED THAT THE PHYSICIAN DEPLOYED A PORTION OF THE PROXIMAL END OF THE STENT INSIDE THE INTRODUCER SHEATH. WHEN THE THUMB SLIDE WAS RETRACTED TO REMOVE THE STENT DELIVERY SYS, IT IS LIKELY THAT THE TIP WAS UNABLE TO FULLY RETRACT BECAUSE THE STENT WAS PARTIALLY INSIDE THE INTRODUCER SHEATH. AS THE STENT DELIVERY SYS AND INTRODUCER SHEATH WERE RETRACTED DISTALLY TO FREE THE STENT, THE TENSILE STRENGTH OF THE TIP/LUMEN ASSEMBLY WAS EXCEEDED AND THE LUMEN DETACHED FROM THE RATCHET STEM. THIS HAS BEEN REVIEWED WITH THE PHYSICIAN AND THE PHYSICIAN IS AWARE OF THE POTENTIAL CAUSE OF THE EVENT. THE PHYSICIAN REPORTED THAT THERE WAS NO EFFECT TO THE PT.

    Description of Event or Problem · 1

    THE PHYSICIAN INITIALLY WANTED TO IMPLANT A 6 X 40 MM STENT IN THE COMMON FEMORAL ARTERY, HOWEVER ONLY A 6 X 80 MM WAS AVAILABLE. THE STENT WAS DEPLOYED AND IT IS SUSPECTED THAT THE STENT WAS PARTIALLY DEPLOYED INSIDE THE INTRODUCER SHEATH. WHEN ATTEMPTING TO REMOVE THE INTRODUCER SHEATH, THE STENT BEGAN TO MOVE WITH THE SHEATH. THE INTRODUCER SHEATH AND THE STENT DELIVERY SYS WERE REMOVED, AND IT WAS OBSERVED THAT THE CATHETER TIP WAS MISSING. THE TIP WAS NOT LOCATED AND THE INTRODUCER SHEATH WAS DISCARDED. THE HOSP STAFF BELIEVES THE TIP WAS REMOVED INSIDE THE SHEATH AND DISCARDED WITH THE SHEATH. THE STENT WAS FULLY DEPLOYED AND WAS PARTIALLY AT THE BIFURCATION PROXIMALLY. IMAGING SHOWED THE VESSEL WAS PATENT AND THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-080-120-6F 01205067

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR GUIDEWIRE: .014 GRANDSLAM| SHEATH: 6FR TERUMO