BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 20239614 · Received September 17, 2024

    Report

    Report Number
    3007284313-2024-03486
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 17, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    UDI-DI
    00733132635023
    PMA / PMN Number
    P040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ENGINEERING ANALYSIS WITH THE DELIVERY SYSTEM CONTAINED WITHIN THE INTRODUCER SHEATH AND THE ENDOPROSTHESIS PARTIALLY DEPLOYED. THE ZIPPER WAS SLIGHTLY BUNCHED FOR THE MOST DISTAL KNOT ROWS, BUT NO ABNORMALITIES WERE NOTED THAT WOULD PREVENT DEPLOYMENT. ENGINEERING ATTEMPTED TO DEPLOY THE REMAINDER OF THE DEVICE, AND THE DEVICE SUCCESSFULLY DEPLOYED. NOT ENOUGH INFORMATION WAS PROVIDED TO DETERMINE THE CAUSE OF THE EVENT. THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION INSTRUCTIONS FOR USE (IFU) WARNS: ¿ INADVERTENT, PARTIAL, OR FAILED DEPLOYMENT OF THE DEVICE OR DEVICE MIGRATION MAY REQUIRE SURGICAL INTERVENTION. 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 THE PHYSICIAN SELECTED A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION (VIATORR®) FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. DURING THE PROCEDURE THE DEVICE FAILED TO DEPLOY. REPORTEDLY, THE UNCOVERED PORTION OF THE DEVICE WAS UNCOVERED FROM THE SHEATH, AND WHEN THE DEPLOYMENT STRING WAS PULLED, THE DEVICE BOWED WITH TENSION AND WOULD NOT DEPLOY. IT APPEARED THE WIRE WAS KINKED AND HAD POSSIBLY LOST SOME OF ITS STRENGTH. AN AMPLATZER GUIDEWIRE WAS USED, SIZE NOT KNOWN. THE SHEATH INFORMATION IS UNKNOWN. ANOTHER VIATORR® OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE, WHICH THE PATIENT TOLERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505896 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC. 00733132635023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H