BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 7928083 · Received October 2, 2018

    Report

    Report Number
    3007284313-2018-00277
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    June 5, 2018
    Report Date
    September 6, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER(S) WERE NOT PROVIDED; THEREFORE, AN INVESTIGATION IS UNABLE TO BE PERFORMED AND A CAUSE OF THE REPORTED EVENTS CANNOT BE DETERMINED. THE GORE® VIATORR® TIPS ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) NOTE THE RISKS AND POTENTIAL ADVERSE EFFECTS OF CREATING A TIPS IN PATIENTS WITH PRE-EXISTING CONDITIONS SUCH AS HEPATIC ENCEPHALOPATHY MUST BE CONSIDERED RELATIVE TO THE POTENTIAL BENEFITS OF THIS PROCEDURE. FURTHER, THE IFU STATES, "PATIENTS SHOULD BE MONITORED CLOSELY FOLLOWING THE PROCEDURE FOR WORSENING HEPATIC ENCEPHALOPATHY. 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." CITATION: ROWLEY MW, CHOI M, CHEN S, HIRSCH K, SEETHARAM AB. REFRACTORY HEPATIC ENCEPHALOPATHY AFTER ELECTIVE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT: RISK FACTORS AND OUTCOMES WITH REVISION. CARDIOVASCULAR & INTERVENTIONAL RADIOLOGY, JUNE 2018.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE ¿REFRACTORY HEPATIC ENCEPHALOPATHY AFTER ELECTIVE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT: RISK FACTORS AND OUTCOMES WITH REVISION" PUBLISHED IN THE JOURNAL OF CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, JUNE 2018. THIS ARTICLE DESCRIBES A RETROSPECTIVE COHORT STUDY OF 174 CONSECUTIVE PATIENTS UNDERGOING ELECTIVE TIPS PLACEMENT FROM 2010-2015 UTILIZING GORE® VIATORR® TIPS ENDOPROSTHESES. ALL STENTS HAD A NOMINAL DIAMETER OF 10MM. THIS ARTICLE EVALUATED THE INCIDENCE, PREDICTORS, AND OUTCOMES OF POST-TIPS REFRACTORY HEPATIC ENCEPHALOPATHY (RFE) NECESSITATING TIPS REVISION. TEN OF THE 174 SUBJECTS DEVELOPED POST-TIPS RHE REQUIRING REVISION. OF THESE TEN PATIENTS, THREE UNDERWENT REVISION WITHIN 30 DAYS OF THE PRIMARY TIPS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768941 GORE VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention