BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 25328269 · Received May 29, 2026

    Report

    Report Number
    3007284313-2026-04817
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 18, 2026
    Report Date
    May 29, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132628117
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. D10: CONCOMITANT MEDICAL PRODUCTS: (RELEVANT ASSOCIATED DEVICES USED WITH THE DEVICE BEING REPORTED ON): GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM. H6: CODE E0515: E051501 SHOULD BE USED INSTEAD OF E0515 (DUE TO SYSTEM LIMITATIONS). CODE B14: PRODUCT HISTORY REVIEW IS ONGOING. 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 THAT ON (B)(6) 2026, A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WAS IMPLANTED TO TREAT A CHRONIC DISSECTION. THE DAY AFTER EVERYTHING LOOKED WELL. A FOLLOW-UP CT SCAN WAS PERFORMED ONE WEEK AFTER THE PROCEDURE, AND IT WAS DISCOVERED THAT THE PATIENT DEVELOPED A PROXIMAL DISSECTION RIGHT AFTER THE LEFT SUBCLAVIAN ARTERY (LSA). ACCORDING TO THE PHYSICIAN THIS CAN ONLY BE RELATED TO THE UPPER VASCULAR ACCESS MADE FOR THE INTRODUCTION OF THE TAMBE BRANCH COMPONENTS, WHERE A 12 F GORE® DRYSEAL FLEX INTRODUCER SHEATH IS USED. THIS ACCESS WAS MADE VIA THE LEFT AXILLARY ARTERY INTO THE LSA AND DOWN THE DESCENDING THORACIC AORTA. THE PATIENT HAS BEEN TREATED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND ONE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS TO CONNECT TO THE TAMBE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440856 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132628117

    Patients

    Seq Age Sex Outcome Treatment
    1