BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 23754118 · Received December 9, 2025

    Report

    Report Number
    3007284313-2025-04442
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 9, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    UDI-DI
    00733132635504
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOTS MET PRE-RELEASE SPECIFICATIONS. CODE D15 - NEITHER CLINICAL IMAGES ENABLING ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION, THE INVESTIGATION COULD NOT BE PERFORMED. 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

    IT WAS REPORTED TO GORE THAT IN THE EVENING ON (B)(6) 2025, A PATIENT WAS TO BE IMPLANTED WITH AN 8MM × 6CM GORE® VIATORR® TIPS ENDOPROSTHESIS (TIPS DEVICE) DURING A TIPS PROCEDURE. ACCESS WAS OBTAINED FROM INTERNAL JUGULAR VEIN, A GUIDE WIRE (TERUMO) AND INTRODUCER SHEATH SET (BETTERWAY MEDTECH) WERE SENT THROUGH THE SUPERIOR VENA CAVA TO THE HEPATIC VEIN. ACCESS WAS SUCCESSFULLY OBTAINED FROM THE HEPATIC VEIN TO THE PORTAL VEIN. A 6MM X 80MM BALLOON WAS USED TO DILATE. BALLOON WAS REMOVED AND TIPS DEVICE WAS INSERTED. DURING THE DELIVERY PROCESS, THE RELATIVE POSITION BETWEEN THE DELIVERY CATHETER AND THE SHEATH OF TIPS SET WAS NOT FIXED PROPERLY, RESULTING IN PARTIAL DISPLACEMENT OF THE DISTAL UNLINED REGION OF TIPS DEVICE FROM THE SHEATH AND PREMATURE DEPLOYMENT, AND THE UNLINED REGION HASN'T FULLY REACHED THE PORTAL VEIN. ATTEMPTS WERE TRIED TO FIX THE TIPS DEVICE AND THE SHEATH AND PUSH THEM FORWARD SYNCHRONOUSLY. HOWEVER, DUE TO EXCESSIVE RESISTANCE, THEY WERE UNABLE TO BE ADVANCED. THEREFORE, BOTH TIPS DEVICE AND THE SHEATH WERE SIMULTANEOUSLY WITHDRAWN. THE SHEATH WAS EVENTUALLY WITHDRAWN FROM PATIENT; TIPS DEVICE REMAINED IN THE INTERNAL JUGULAR VEIN AND WAS COMPLETELY DEPLOYED. A SECOND TIPS DEVICE WAS USED, AND PROCEDURE WAS SUCCESSFULLY DEPLOYED. THE FIRST TIPS DEVICE WAS REMOVED FROM RIGHT INTERNAL JUGULAR VEIN VIA SURGERY. PATIENT TOLERATED THE PROCEDURE AND WAS TRANSFERRED TO ICU, AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2774359 GORE® VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC. 00733132635504

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention