BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2786929 · Received October 8, 2012

    Report

    Report Number
    3005325609-2012-00029
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OVERMOLD OF THE TIP DETACHED FROM THE LUMEN DUE TO INTERACTION WITH THE INTRODUCER. IT IS LIKELY THAT THE DISTAL END OF THE DELIVERY SYSTEM WAS IN CLOSE PROXIMITY OF THE DISTAL END OF THE INTRODUCER WHICH RESULTED IN SNAGGING THE PROXIMAL EDGE OF THE TIP OVERMOLD WHEN THE THUMB SLIDE WAS RETRACTED AND LOCKED AFTER STENT DEPLOYMENT. THERE IS A CAPA AND DESIGN CHANGE IN PROCESS TO ELIMINATE THE POTENTIAL CATCH POINT ON THE TIP. IN REGARDS TO THE REPORTED DIFFICULTY MOVING THE THUMB SLIDE, THE LIKELY ROOT CAUSE WAS THE LACK OF PRE-DILATING THE STRICTURE BEFORE ADVANCING THE DELIVERY SYSTEM TO THE TARGETED SITE.

    Description of Event or Problem · 1

    THE STENT WAS BEING PLACED INTO THE COMMON BILIARY DUCT. NO PRE-DILATION OF THE STRICTURE WAS DONE. IT WAS REPORTED THAT DEPLOYMENT BEGAN OK AND THEN THE THUMB SLIDE BECAME DIFFICULT TO MOVE. AFTER SEVERAL THUMB SLIDE RETRACTIONS, DEPLOYMENT RETURNED AS NORMAL. THE PHYSICIAN THOUGHT THAT THE STENT WAS FULLY DEPLOYED AND HE PULLED BACK THE THUMB SLIDE AND LOCKED IT. THE CATHETER WAS WITHDRAWN AND IT WAS DISCOVERED THAT THE TIP WAS ON THE GUIDEWIRE INSIDE THE DUODENUM. THE PHYSICIAN POST-DILATED WITH A BALLOON AND USED A SNARE TO REMOVE THE TIP. THE PHYSICIAN WAS SATISFIED WITH THE PLACEMENT OF THE STENT. F/U WITH THE PHYSICIAN APPROX TWO WEEKS LATER CONCLUDED THAT THE COMMON BILIARY DUCT WAS DRAINING WELL WITH NO PT EFFECT FROM THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-07-080-080-6F 06064025

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R BALLOON: RIVAL 8 MM X 4 CM| SHEATH: 6F| SNARE KIT: 120-10 MM| 0.038 AMPLATZ GOOSE NECK| GUIDE WIRE: 0.200 CM V-18| GUIDE WIRE: 0.035" 260 CM AMPLATZ SUPER STIFF