BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V12 COVERED STENT

    MDR report key: 3063712 · Received April 12, 2013

    Report

    Report Number
    1219977-2013-00036
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE IS CURRENTLY UNDER EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE MET ALL SPECIFICATIONS WITHOUT ANY DEVIATIONS.

    Description of Event or Problem · 1

    THE V12 DEVICE GOT STUCK IN THE INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158133 V12 COVERED STENT PTFE COVERED STENT JCT ATRIUM MEDICAL CORP. 85336 10727121

    Patients

    Seq Age Sex Outcome Treatment
    1