BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 13954593 · Received March 30, 2022

    Report

    Report Number
    3007284313-2022-01842
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 2, 2021
    Report Date
    March 30, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: JAMES H. HELZBERG, RUI DAI, ANDREW J. MUIR, JULIUS WILDER, TZU-HAO LEE, JONATHAN G. MARTIN, CHARLES Y. KIM, JAMES RONALD, SOCIOECONOMIC STATUS IS ASSOCIATED WITH THE RISK OF HEPATIC ENCEPHALOPATHY AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION, JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, VOLUME 32, ISSUE 7, 2021, PAGES 950-960.E1, ISSN 1051-0443, HTTPS://DOI.ORG/10.1016/J.JVIR.2020.11.022. PATIENT DEMOGRAPHICS WERE PROVIDED AND USED AS THE PATIENT INFORMATION, AS FOLLOWS: (MEAN AGE = 56.7 YEARS; N = 229 MALES) BASED ON THIS INFORMATION, THE PATIENT INFORMATION WILL BE POPULATED AS 57 YEARS OLD AND MALE. THE GORE® VIATORR® TIPS ENDOPROSTHESIS INSTRUCTIONS FOR USE NOTE THAT 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

    THIS INFORMATION WAS RECEIVED THROUGH CLINICAL STUDY "SOCIOECONOMIC STATUS IS ASSOCIATED WITH THE RISK OF HEPATIC ENCEPHALOPATHY AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION" AVAILABLE ONLINE IN THE JOURNAL OF VASCULAR AND INTERVENTION RADIOLOGY, 2 MARCH 2021. THIS SINGLE-INSTITUTION RETROSPECTIVE STUDY INCLUDED 368 PATIENTS FROM 5 STATES WHO UNDERWENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) CREATION WITH THE GORE® VIATORR® TIPS ENDOPROSTHESIS AND THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION FROM JANUARY 1, 2005 TO DECEMBER 31, 2019. EPISODES OF NEW OR WORSENING HEPATIC ENCEPHALOPATHY (HE) AFTER TIPS CREATION, DEFINED AS HOSPITALIZATION FOR HE OR ESCALATION IN OUTPATIENT MEDICAL THERAPY, WERE IDENTIFIED FROM MEDICAL RECORDS. THE ARTICLE REPORTS THAT THE REQUIRING HOSPITALIZATION WITHIN 30 DAYS OF TIPS CREATION OCCURRED IN 68 OF 368 PATIENTS (18.5%). TIPS OCCLUSION WAS PERFORMED IN 2 PATIENTS, AND TIPS REDUCTION WAS PERFORMED IN 13 PATIENTS FOR REFRACTORY HE. TIPS REDUCTION WAS PERFORMED IN AN ADDITIONAL 3 PATIENTS FOR HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107929 GORE® VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other| R