BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2550451 · Received April 19, 2012

    Report

    Report Number
    3005325609-2012-00009
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE HOSPITAL IS NOT RELEASING THE DEVICE. AN IDEV ENGINEER VISITED THE HOSPITAL AND WAS ABLE TO VIEW THE DEVICE. THE LUMEN DISLODGED AT THE DISTAL END OF THE NITINOL RATCHET STEM. IT WAS REPORTED THAT THE TIP MAY HAVE BEEN LODGED WITHIN A STENT WIRE THEREFORE, THE FORCE OF THE REMOVAL MAY HAVE CONTRIBUTED TO THE TIP/LUMEN DISLODGING. OTHER PERTINENT INFO RELATED TO THE EVENT HAS BEEN REQUESTED BUT HAS NOT BEEN RELEASED TO IDEV. IDEV IS ATTEMPTING TO OBTAIN ADD'L INFO. AN MDR SUPPLEMENT WILL BE SUBMITTED IF ADD'L RELEVANT INFO IS OBTAINED.

    Description of Event or Problem · 1

    THE STENT WAS DEPLOYED AND UPON RETRACTING THE TIP BEFORE REMOVING THE CATHETER, THE TIP/LUMEN ASSEMBLY BECAME DETACHED AND LODGED WITHIN THE STENT BUT STAYED ON THE GUIDE WIRE. SEVERAL ATTEMPT WERE MADE TO RETRIEVE THE TIP/LUMEN. THE TIP/LUMEN AND STENT WAS SURGICALLY REMOVED BY ACCESSING THE POPLITEAL ARTERY. THE TIP WAS STILL WITHIN THE STENTED REGION AND APPEARED LODGED IN THE WALL OF THE STENT. THE POPLITEAL ARTERY WAS THEN LIGATED FOLLOWED BY THE BYPASS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-04-100-120-6F 01190054

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| R BALLOON: SAVVY 4X40| GUIDEWIRE: TREASURE .018