BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 24851727 · Received April 11, 2026

    Report

    Report Number
    3007284313-2026-04699
    Event Type
    Death
    Date Received
    April 11, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 10, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE B22 - THE DEVICE SERIAL NUMBER IS UNKNOWN, THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. H6: CODE C20 -THE DEVICE WAS DISCARDED AT THE TREATING FACILITY AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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

    ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION IN THE THORACIC AORTA UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). IN ADDITION, GORE® DRYSEAL FLEX INTRODUCER SHEATH(S) AND NON-GORE (COOK) SHEATH(S) WERE UTILIZED IN THIS PROCEDURE. REPORTEDLY, THE PATIENT HAD VARIOUS NON-GORE DEVICE RELATED COMPLICATIONS OCCURRING DURING THIS PROCEDURE (REFERENCE (B)(4)). IT WAS ALSO REPORTED AS THE PHYSICIAN WAS PREPARING TO COMPLETE THE PROCEDURE, A 20 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS PULLED BACK, CONTRAST WAS SHOT THROUGH THE SHEATH, AND A RUPTURE WAS SEEN IN THE ILIAC ARTERY. THE PHYSICIAN THEN IMPLANTED A GORE® VIABAHN® ENDOPROSTHESIS AND PULLED THE SHEATH OUT OF THE PATIENT, BUT STILL EXTRAVASATION WAS STILL SEEN DISTAL. THIS RESULTED IN A FEMORAL CUTDOWN. IT WAS REPORTED THE 20 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS THE CORRECT SIZE FOR THE PATIENT'S ANATOMY. AS NOTED IN (B)(4), THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL ONE DAY LATER ON (B)(6) 2026 AND HAD TO HAVE THEIR ABDOMEN OPENED AS THERE WAS POOR BLOOD FLOW TO THE COLON RESULTING IN A DEAD COLON. REPORTEDLY, THE PHYSICIAN THOUGHT THE ORGANS LOOKED OK. IN ADDITION, THE PATIENT HAD A FOLLOW-UP CT SCAN ON A LATER UNKNOWN DATE AND EVERYTHING APPEARED PATENT. CLINICAL IMAGES ARE UNAVAILABLE. ON (B)(6) 2026 THE PATIENT EXPIRED LIKELY DUE TO MULTIPLE ISSUES DISCUSSED IN (B)(4); HOWEVER, THE ILIAC RUPTURE AND FEMORAL CUTDOWN ASSOCIATED WITH THE SHEATH COULD HAVE CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907038 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| R| O| L| D