BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V12 COVERED STENT

    MDR report key: 3121889 · Received May 15, 2013

    Report

    Report Number
    1219977-2013-00060
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 5, 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 ADDITIONAL 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 THAT THE ADVANTA STENT WAS BROKEN AFTER ONE MONTH ON A TYPE III ENDOLEAK (SECONDARY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215025 V12 COVERED STENT PTFE COVERED STENT JCT ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other