BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 23800143 · Received December 15, 2025

    Report

    Report Number
    3007284313-2025-04452
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 15, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630073
    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: CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D1101: INSTRUCTION FOR USE (IFU) OF GORE® DRYSEAL FLEX INTRODUCER SHEATH STATES THAT IF VESSEL SIZE IS SMALLER THAN THE NOMINAL BODY OUTER DIAMETER, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PATIENT, INCLUDING DEATH, MAY RESULT. 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) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR SUBACUTE TYPE B AORTIC DISSECTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY. AFTER SUCCESSFUL DEPLOYMENT OF THE CTAG AC, PULSE ON THE RIGHT LOWER LIMB WAS UNPALPABLE DURING CLOSURE OF THE SURGICAL INCISION. AN ANGIOGRAPHY FOUND VASCULAR DISSECTION ON THE RIGHT EXTERNAL ILIAC ARTERY. ANOTHER CUT-DOWN WAS MADE ON THE RIGHT FEMORAL ARTERY AND ENDARTERECTOMY WAS PERFORMED. AFTER THAT, BLEEDING FROM THE DISTAL SITE OF THE RIGHT EXTERNAL ILIAC ARTERY WAS NOTED; THEREFORE, TWO COVERED STENTS WERE ADDITIONALLY IMPLANTED IN THE EXTERNAL ILIAC ARTERY, AND THE BLEEDING WAS STOPPED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS 6.8 TO 7.7 MM AND SMALLER THAN THE OUTER DIAMETER OF THE 22 FR SHEATH. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: ALTHOUGH NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE SHEATH, THERE WAS RESISTANCE WHEN WITHDRAWING IT, SO THE DISSECTION PROBABLY OCCURRED AT THAT TIME. AS FOR THE BLEEDING, IT WAS HIGHLY POSSIBLY DUE TO THE ENDARTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325299 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630073

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention