BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 19405797 · Received May 28, 2024

    Report

    Report Number
    3007284313-2024-03268
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 28, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 BUNCHED AND TWISTED, BUT NO ABNORMALITIES WERE NOTED IN THE MOST DISTAL ZIPPER KNOT ROW 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. 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 TO GORE A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION WAS SELECTED FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE PHYSICIAN HAD THE STENT IN PLACE AND THE UNCOVERED PORTION WAS DEPLOYED, BUT AS THE PHYSICIAN CONTINUED TO PULL THE CORD TO DEPLOY THE COVERED ASPECT OF THE STENT IT DIDN¿T OPEN AND SUBSEQUENTLY PROLAPSED INTO THE INFERIOR VENA CAVA/RIGHT ATRIUM. THE PHYSICIAN WAS ABLE TO RE-SHEATH THE COVERED ASPECT OF THE STENT BUT HAD TO PULL THE UNCOVERED PORTION OUT THROUGH THE VENOUS ACCESS SITE TO FULLY RETRIEVE IT, MAKING A MUCH LARGER RIGHT INTERNAL JUGULAR DEFECT THAN THE ORIGINAL 10 FR SHEATH. A SECOND GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION WAS SUCCESSFULLY IMPLANTED. THE DEVICE WAS RETURNED FOR ENGINEERING ANALYSIS. THE EVALUATION SHOWED A PARTIALLY DEPLOYED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299931 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other