BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 23610041 · Received November 20, 2025

    Report

    Report Number
    3007284313-2025-04385
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 21, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630950
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). THE PATIENT¿S ABDOMINAL AORTA HAD BEEN REPLACED WITH A Y-SHAPED SYNTHETIC GRAFT, AND A 10 MM DIAMETER SYNTHETIC GRAFT (MANUFACTURER UNKNOWN) WAS USED AS A CONDUIT. ON AN UNKNOWN DATE, ENLARGEMENT OF THE VESSEL DIAMETER AT THE DISTAL END OF THE PREVIOUSLY IMPLANTED CTAG WAS OBSERVED. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION. (ADDRESSED IN #2017233-2025-06848.) THE LIGATED PORTION OF THE PREVIOUS CONDUIT WAS TRANSECTED AND ANASTOMOSED TO A NEW SYNTHETIC GRAFT (MANUFACTURER UNKNOWN). UPON INSERTION OF A 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), RESISTANCE WAS ENCOUNTERED NEAR THE ANASTOMOSIS BETWEEN THE Y-SHAPED SYNTHETIC GRAFT AND THE PREVIOUS CONDUIT, AND THE DSF WAS ADVANCED THROUGH THE SITE WITH APPLIED FORCE. THE FIRST CTAG WAS DEPLOYED DISTALLY, BUT ITS DISTAL END WAS POSITIONED MORE PROXIMALLY THAN INTENDED. AFTER DEPLOYING THE SECOND CTAG, A DISTAL TYPE I ENDOLEAK WAS OBSERVED. A TOUCH-UP PROCEDURE WAS PERFORMED, RESULTING IN A SLIGHT RESIDUAL DISTAL TYPE I ENDOLEAK. FOLLOWING DSF REMOVAL, ANGIOGRAPHY REVEALED BLOOD LEAKAGE NEAR THE ANASTOMOSIS SITE. THE AREA WAS SURGICALLY REPAIRED, AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309181 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630950

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention