BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 21907648 · Received April 25, 2025

    Report

    Report Number
    3007284313-2025-03927
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    March 2, 2025
    Report Date
    July 17, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODE A24: A24 WAS USED FOR HEPATIC ENCEPHALOPATHY WITH HOSPITALIZATION WITHIN 30 DAYS. H6 CODES B14, C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOTS MET PRE-RELEASE SPECIFICATIONS. H3 "OTHER"; H6 CODES B20, C20: THE DEVICE REMAINS IMPLANTED AND WAS, THEREFORE, NOT AVAILABLE FOR ANALYSIS. NO CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE WERE RETURNED FOR EVALUATION. 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

    H3 OTHER; H6 CODES B14, B20, C20, D15, D12: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOTS MET PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS, THEREFORE, NOT AVAILABLE FOR ANALYSIS. NO CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE WERE RETURNED FOR EVALUATION. IN THE IFU FOR THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION THE FOLLOWING IS STATED: ADVERSE EVENTS POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION OR IN ANY TIPS PROCEDURE AND REQUIRE INTERVENTION MAY INCLUDE, BUT ARE NOT LIMITED TO: NEW ONSET OR WORSENED HEPATIC ENCEPHALOPATHY

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE FROM THE VTR 21-09 VIEDOC STUDY DATABASE: ON (B)(6) 2025, THIS 59-YEAR-OLD MALE PATIENT UNDERWENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE FOR ASCITES. A GORE® TIPS SET WAS SUCCESSFULLY USED TO ACCESS THE HEPATIC VEIN WITH TWO PORTAL VEIN PUNCTURES DUE TO THE ANGLE OF THE PORTAL VEIN. THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION [STENT] WAS SUCCESSFULLY DELIVERED. ON MARCH 2, 2025, IT WAS REPORTED THE PATIENT HAD A HOSPITALIZATION FOR ENCEPHALOPATHY. THE EVENT WAS NOTED TO BE RESOLVED ON MARCH 7, 2025. THE SITE ASSESSED THIS EVENT AS RELATED TO THE PROCEDURE, BUT NOT THE STENT. THE PATIENT RECOVERED WITHOUT SEQUELAE AFTER MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480266 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization