BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 18071922 · Received November 6, 2023

    Report

    Report Number
    3007284313-2023-02875
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    December 10, 2015
    Report Date
    November 6, 2023
    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

    H3 OTHER CODE: AS THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE PERFORMED. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE, NOR THE DEVICE WAS RETURNED FOR INVESTIGATION. 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. THE GORE® VIATORR® TIPS ENDOPROSTHESIS INSTRUCTIONS FOR USE LIST OCCLUSION AS A POTENTIAL ADVERSE EVENT. LITERATURE CITATION: MARUZZELLI, L., D¿AMICO, M., TUZZOLINO, F. ET AL. CLINICAL OUTCOMES OF TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT WITH PTFE-COVERED STENTS AFTER LIVER TRANSPLANTATION AND TECHNICAL RESULTS IN SPLIT AND WHOLE LIVER GRAFT RECIPIENTS. EUR RADIOL 33, 2612¿2619 (2023). HTTPS://DOI.ORG/10.1007/S00330-022-09259-4. 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

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "CLINICAL OUTCOMES OF TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT WITH PTFE-COVERED STENTS AFTER LIVER TRANSPLANTATION AND TECHNICAL RESULTS IN SPLIT AND WHOLE LIVER GRAFT RECIPIENTS" PUBLISHED ONLINE 23 NOVEMBER 2022 IN EUROPEAN RADIOLOGY. THE AIM OF THIS STUDY WAS TO ASSESS THE OUTCOMES OF TIPS CREATION USING POLYTETRAFLUOROETHYLENE (PTFE)-COVERED STENTS IN LIVER TRANSPLANT RECIPIENTS AND TO ANALYZE THE TECHNICAL RESULT IN SPLIT LIVER GRAFT (SG) COMPARED WITH WHOLE LIVER GRAFTS (WG). THE STUDY COHORT CONSISTED OF 48 PATIENTS TREATED WITH GORE® VIATORR® TIPS ENDOPROSTHESIS. ADDITIONAL INFORMATION REPORTED BY THE AUTHOR NOTES THAT ONE PATIENT REQUIRED REINTERVENTION (ANGIOPLASTY OR RESTENTING) THE DAY FOLLOWING IMPLANT DUE TO OCCLUSION OR STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961657 GORE® VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention