BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 23660198 · Received November 26, 2025

    Report

    Report Number
    3007284313-2025-04399
    Event Type
    Death
    Date Received
    November 26, 2025
    Date of Event
    October 24, 2025
    Report Date
    February 24, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION CONCLUSIONS CODE D14: BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN, THERE IS NO ALLEGATION OF DEFICIENCY AGAINST THE GORE DEVICE. THEREFORE, THIS REPORT IS BEING RETRACTED. UPDATED B.5. DESCRIPTION OF EVENT. UPDATED B.1. TO DESELECT ADVERSE EVENT. UPDATED H.6. TYPE OF INVESTIGATION FROM B21 TO B13, B14, B20. UPDATED H.6. INVESTIGATION FINDINGS FROM C21 TO C19, C20. UPDATED H.6. INVESTIGATION CONCLUSIONS FROM D16 TO D14.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS CODE C21: CONCLUSIONS PENDING FURTHER COMMUNICATION WITH SITE. 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.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

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM. ACCESS WAS GAINED USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). ON (B)(6) 2025, AFTER THE PROCEDURE, THE PATIENT DEVELOPED A RETROGRADE TYPE A DISSECTION, STARTING FROM THE PROXIMAL EXTENT OF THE TAMBE DEVICE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE DISSECTION WAS ARCH MANIPULATION AND SHEATH/GUIDEWIRE AXILLARY ACCESS, AND WAS NOT RELATED TO THE TAMBE DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM. ACCESS WAS GAINED USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). DURING THE PROCEDURE, AFTER CANNULATION, THE TAMBE WAS RECONSTRAINED. ON (B)(6) 2025, THE PATIENT DEVELOPED A RETROGRADE TYPE A DISSECTION, STARTING FROM THE PROXIMAL EXTENT OF THE TAMBE DEVICE. ACCORDING TO THE INFORMATION IN IMEDIDATA, THE CAUSE OF THE DISSECTION WAS THE DSF. ON (B)(6) 2025, IT WAS REPORTED TO GORE THAT THE PATIENT HAD DIED. THE EXACT DATE OF DEATH REMAINS UNKNOWN. CURRENTLY REACHING OUT TO THE SITE FOR MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679293 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death