BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 19298616 · Received May 13, 2024

    Report

    Report Number
    3007284313-2024-03225
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 18, 2024
    Report Date
    May 13, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    UDI-DI
    00733132635047
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE, GENDER AND WEIGHT ARE NOT AVAILABLE FROM THE HOSPITAL. THE VIATORR INSTRUCTIONS FOR USE STATES POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS INCLUDE: -SHUNT STENOSIS OR OCCLUSION. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE WHERE A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION (VIATORR DEVICE) WAS IMPLANTED. ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION PROCEDURE. IT WAS REPORTED THERE WAS VERY SUBTLE NARROWING OF THE VIATORR DEVICE AND THE PATIENT WAS NOT EXPERIENCING OPTIMAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437926 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC. 00733132635047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other