BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2449826 · Received February 2, 2012

    Report

    Report Number
    3005325609-2012-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    December 22, 2011
    Report Date
    December 22, 2011
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINED IMPLANTED. A PHOTOGRAPH OF THE LABEL AND AN ANGIOGRAM OF THE IMPLANTED STENT WERE RECEIVED FOR EVALUATION. THE ANGIOGRAM CONCLUDED THAT THE DEVICE WAS LONGER THAN THE INTENDED 40MM (APPROXIMATELY 100-120MM) LENGTH. THE LABEL WAS CONFIRMED TO READ 40MM IN LENGTH; THEREFORE THE LABELED LENGTH WAS INCORRECT. THE COMPLAINT INVESTIGATION CONCLUDED THAT THE DEVICE WAS MISLABELED. A CAPA WAS OPENED. FURTHER EVALUATION OF THE INCIDENT CONCLUDED THAT DURING A RE-WORK LABELING PROCESS, THE DEVICES LABELING WAS MIXED WITH ANOTHER DEVICE'S LABELING. A FIELD ACTION WAS INITIATED. THE OTHER DEVICE WAS RETRIEVED FROM THE HOSPITAL AND A VERIFICATION THAT THE TWO LABELS WERE MIXED WAS DONE. THIS DEVICE WAS LABELED (B)(4); LOT 05180062. ADDITIONAL CORRECTIVE ACTIONS WERE TAKEN AND WERE REPORTED TO FDA ON. THE PATIENT'S AGE, SEX AND WEIGHT WERE NOT KNOWN AT THE TIME OF THIS REPORT. A SUPPLEMENT WILL BE SENT WHEN THE INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A STENT LABELED 40MM IN LENGTH DEPLOYED TO 100MM OR MORE. THE PHYSICIAN WAS TREATING A LESION IN THE DISTAL SFA AND ONLY NEEDED A 4X40MM STENT. ONCE THE STENT WAS DEPLOYED, THE PHYSICIAN SAW THAT IT DEPLOYED TO 100MM OR MORE. IT WAS REPORTED THAT THE STENT WAS LEFT IN PLACE AND THERE WAS NO EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-04-040-120-G3 05180031

    Patients

    Seq Age Sex Outcome Treatment
    1