BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V12 COVERED STENT

    MDR report key: 3131509 · Received May 14, 2013

    Report

    Report Number
    1219977-2013-00055
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IN PROCESS OF EVALUATING.

    Description of Event or Problem · 1

    THE V12 STENT BOX 10MM X 59MM X 120CM WAS OPENED, THE STENT REMOVED FROM THE PACKAGING AND HANDED TO THE SURGEON. ON IMPLANTATION THE SURGEON REALIZED THE STENT WAS NOT AN 8MM X 59MM X 120 MM. AN INCORRECT STENT WAS IN THE BOX. PRODUCT WAS THEN WITHDRAWN AND THE SURGEON REQUESTED THE CORRECT SIZE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214102 V12 COVERED STENT PTFE COVERED STENT JCT ATRIUM MEDICAL CORP. 85365 10873026

    Patients

    Seq Age Sex Outcome Treatment
    1