BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 18658265 · Received February 7, 2024

    Report

    Report Number
    2017233-2024-04601
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 5, 2024
    Report Date
    February 7, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132654093
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. H6: CODE B20 ¿ THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. IT SHOULD BE NOTED THAT, PER THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK. PATIENT MEDICATION INCLUDES: ALBUTEROL CYMBALTA COPAXONE LOSARTAN 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) 2023, PATIENT UNDERWENT TREATMENT FOR AN ACUTE TYPE B DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE-TAC083415A). PROCEDURE WAS COMPLETED AND A SMALL TYPE 1A ENDOLEAK WAS IDENTIFIED. PHYSICIAN DECIDED TO MONITOR THIS LEAK. ON AN UNKNOWN DATE, A CT SCAN WAS PERFORMED WHICH REVEALED A LARGER LEAK, VERY LIKELY A TYPE 1A ENDOLEAK. PHYSICIAN STILL DECIDED TO MONITOR THIS LEAK, WITH NO PLANS FOR REINTERVENTION SURGERY. ON (B)(6) 2023, AN ADDITIONAL CT SCAN WAS PERFORMED. THE TYPE 1A ENDOLEAK SEEMED TO MOSTLY RESOLVE, HOWEVER THERE WAS STILL A SMALL LEAK THAT REMAINED. ON (B)(6) 2023 PATIENT UNDERWENT REINTERVENTION SURGERY DUE TO THIS SMALL RESIDUAL TYPE 1 ENDOLEAK. A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC EXTENDER) WAS IMPLANTED TO EXTEND PROXIMALLY. PHYSICIAN BELIEVES THIS ENDOLEAK IS LIKELY DUE TO PATIENT ANATOMY AND DISEASE PROGRESSION. FSA ALSO REPORTS PATIENT MEASUREMENTS ARE NOT AVAILABLE, BUT MEASUREMENTS WERE IN ACCORDANCE WITH IFU. PATIENT TOLERATED THE PROCEDURE. NO PATIENT IMAGES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080062 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132654093

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention