BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V12 COVERED STENT

    MDR report key: 3121879 · Received May 15, 2013

    Report

    Report Number
    1219977-2013-00059
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING ADD'L DETAILS ON THE EVENT IN ORDER TO COMPLETE THE ANALYSIS. HOSPITAL DID PROVIDE A FILM FOR THE INVESTIGATION.

    Description of Event or Problem · 1

    HOSPITAL REPORTED ASYMMETRICAL INFLATION OF ADVANTA BALLOON WITH PROXIMAL MIGRATION OF THE STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214266 V12 COVERED STENT PTFE COVERED STENT JCT ATRIUM MEDICAL CORP. 85353 10859002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other