BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 13225099 · Received January 11, 2022

    Report

    Report Number
    3007284313-2022-01742
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    March 30, 2021
    Report Date
    January 11, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: WOERNER AJ, SHIN DS, CHICK JFB, KOO KSH, HSU EK, TANG ER, MONROE EJ. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION MAY BE ASSOCIATED WITH HYPERPLASTIC HEPATIC NODULAR LESIONS IN THE LONG TERM: AN ANALYSIS OF 18 PEDIATRIC AND YOUNG ADULT PATIENTS. PEDIATR RADIOL. 2021 JUL;51(8):1348-1357. DOI: 10.1007/S00247-021-05010-1. EPUB 2021 (B)(6). PMID: (B)(4). AS THE DATE OF EVENT IS UNKNOWN, THE DATE THE ARTICLE WAS PUBLISHED ONLINE (B)(6) 2021 WILL BE USED AS EVENT DATE. THE FOLLOWING PATIENT IDENTIFIERS FROM THE ARTICLE WILL BE USED, FEMALE (55.6%), MEAN AGE (B)(6), MEAN WEIGHT (B)(6) KG. ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHOR BUT WAS NOT PROVIDED. THE GORE® VIATORR® TIPS ENDOPROSTHESIS INSTRUCTIONS FOR USE INCLUDES, BUT IS NOT LIMITED TO THE FOLLOWING POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE: THROMBUS FORMATION

    Description of Event or Problem · 0

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION MAY BE ASSOCIATED WITH HYPERPLASTIC HEPATIC NODULAR LESIONS IN THE LONG TERM: AN ANALYSIS OF 18 PEDIATRIC AND YOUNG ADULT PATIENTS". PUBLISHED ONLINE IN PEDIATRIC RADIOLOGY. (B)(6) 2021. THE ARTICLES OBJECTIVE/AIM IS TO REPORT ON THE DEVELOPMENT OF HYPERPLASTIC HEPATIC NODULAR LESION DEVELOPMENT IN CHILDREN AND YOUNG ADULTS (<21 YEARS) WITH TIPS PATENCY >3 YEARS. THE ARTICLE REPORTS EIGHTEEN CHILDREN AND YOUNG ADULTS, INCLUDING 10 (55.6%) FEMALES AND 8 (44.4%) MALES, UNDERWENT TIPS CREATION WITH >3 YEARS¿ PATENCY AND FOLLOW-UP EVALUATION AT A TERTIARY CHILDREN¿S HOSPITAL. THE MEAN AGE AT THE TIME OF TIPS CREATION WAS 12.5. THE MEAN WEIGHT AT THE TIME OF TIPS CREATION WAS 43.7KG. ALL (18/18, 100%) SHUNT PLACEMENTS WERE SUCCESSFUL. IN ONE (5.6%) PATIENT, A DIRECT INTRAHEPATIC PORTOSYSTEMIC SHUNT WAS CREATED DUE TO THE CAVERNOUS TRANSFORMATION OF THE PORTAL VEIN WITH A PREVIOUS SPLENECTOMY. TWENTY-ONE STENTS WERE DEPLOYED, INCLUDING 20 VIATORR STENT-GRAFTS (W.L. GORE & ASSOCIATES, FLAGSTAFF, AZ) AND ONE EXPRESS STENT (BOSTON SCIENTIFIC, MARLBOROUGH, MA). ONE PATIENT DEVELOPED THROMBOSIS WITHIN 30 DAYS OF PLACEMENT REQUIRING THROMBOLYSIS AND STENT EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242114 GORE® VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention| H