BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 18439972 · Received January 3, 2024

    Report

    Report Number
    3007284313-2024-02987
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    November 26, 2023
    Report Date
    March 4, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION INSTRUCTIONS FOR USE STATE "PATIENTS SHOULD BE MONITORED CLOSELY FOLLOWING THE PROCEDURE FOR WORSENING HEPATIC ENCEPHALOPATHY. THOSE PATIENTS WHO DEVELOP HEPATIC ENCEPHALOPATHY THAT IS NOT RESPONSIVE TO MEDICAL THERAPY MAY REQUIRE REDUCTION OR OCCLUSION OF THE TIPS TRACT TO CONTROL THE SYMPTOMS."

    Description of Event or Problem · 0

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT WAS REPORTED TO HAVE HEPATIC ENCEPHALOPATHY GRADE 1. THIS RESULTED IN HOSPITAL READMISSION AND REQUIRED MEDICATION. THE PATIENT THEN RECOVERED WITHOUT SEQUELAE AND WAS DISCHARGED HOME ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491402 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention