BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 23015388 · Received September 10, 2025

    Report

    Report Number
    2017233-2025-06586
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 10, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132654345
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE B20 -THE DEVICE REMAINS IMPLANTED 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

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) TO TREAT A DISSECTION UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT, SIDE BRANCH AND AORTIC EXTENDER). PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE ON A PRIOR TEVAR TO TREAT AN ENDOLEAK AND DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). REPORTEDLY, THERE WAS A TYPE 1A ENDOLEAK FROM THE LEFT SUBCLAVIAN ARTERY WITH THE SIDE BRANCH AND A DISTAL EXTENSION OF THE TYPE B DISSECTION FROM THE AORTIC COMPONENT. THE ENDOLEAK IS POSSIBLY DUE TO A FENESTRATION THAT WAS NOT SEALED PERFECTLY ON THE PROXIMAL SIDE DURING THE ORIGINAL PROCEDURE AND THE DISTAL SIDE WHERE THE DISSECTION MIGHT NOT HAVE BEEN FULLY COVERED. PHYSICIAN IS UNSURE OF THE CAUSE, IF ITS A NEW FENESTRATION OR SIMPLY DID NOT COVER IT ENOUGH DURING THE INITIAL PROCEDURE AS THERE IS FALSE LUMEN PROXIMALLY (ANEURYSM SIZE UNKNOWN) AND TYPE B DISSECTION DISTALLY, WHICH PHYSICIAN FIXED BY ADDING 10-15 TERUMO COILS PROXIMALLY IN THE FALSE LUMEN, JUST OUTSIDE THE LEFT SUBCLAVIAN ARTERY AND EXTENDED DISTALLY FROM THE AORTIC COMPONENT WITH THE CTAGAC FULLY COVERING THE DISSECTION. PATIENT TOLERATED THE PROCEDURE. 5900-C IS USED TO CAPTURE THE FALSE LUMEN EXPANSION AS ITS UNKNOWN, IF ITS IN THE TREATED OR UNTREATED AREA OF THE DISSECTION. 5700-C IS USED TO CAPTURE THE UNKNOWN ANEURYSM SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062905 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132654345

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention| H| O