BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 4153381 · Received October 8, 2014

    Report

    Report Number
    3007284313-2014-00091
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    December 31, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS DISCARDED, SO NO ENGINEERING INVESTIGATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MODEL NUMBER. DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT PRESENTED WITH RECURRENT ENCEPHALOPATHY. THE PATIENT HAD TWO GORE® VIATORR® TIPS ENDOPROSTHESIS IN PLACE AND REQUIRED A TIPS REVISION FOR A SHUNT REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630551 GORE VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W.L. GORE & ASSOCIATES PT108275 12354367

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other