BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 20394049 · Received October 8, 2024

    Report

    Report Number
    2017233-2024-05382
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    October 31, 2023
    Report Date
    October 8, 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

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECTS THE STUDY NUMBER WITH CODES FOR THE HOSPITAL AND PATIENT. H3: OTHER: AS THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE CONDUCTED. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE, NOR THE DEVICE WAS RETURNED FOR EVALUATION. H6 EVALUATION CODES INVESTIGATION FINDINGS C19 REFERS TO THE PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOTS MET PRE-RELEASE SPECIFICATIONS. WITH THE INFORMATION PROVIDED TO GORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED. IN THE INSTRUCTION FOR USE 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: 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 HAVE NOT 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 SEPTEMBER 20, 2024 FROM THE VIEDOC STUDY DATABASE: ON (B)(6) 2023, AN ATTEMPT WAS MADE TO PERFORM A TIPS PROCEDURE, HOWEVER ACCESS TO THE INFERIOR CAVA VEIN WAS NOT ACCESSIBLE AND THE PATIENT WAS RESCHEDULED. ON (B)(6) 2023, THIS 44-YEAR-OLD PATIENT UNDERWENT TIPS PROCEDURE. THE PATIENT WAS TREATED WITH A COOK RING TIPS SET AND THREE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION DEVICES TO THE PORTAL VEIN. THE STUDY DEVICES WERE SUCCESSFULLY DELIVERED DURING THE PROCEDURE. ON (B)(6) 2023, A REINTERVENTION TOOK PLACE. ON (B)(6) 2023, AN ADDITIONAL GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION DEVICE WAS IMPLANTED. THIS EVENT WAS RELATED TO STENOSIS WITHIN THE STUDY DEVICE. AT THE END OF THE PROCEDURE PATENCY WAS RESTORED. IT IS NOTED THAT HOSPITALIZATION WAS NOT REQUIRED FOR THIS INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546927 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention