BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 25049241 · Received April 30, 2026

    Report

    Report Number
    2017233-2026-07444
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 30, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132654208
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS ARE WAITING FOR RESULTS OF EVALUATION OF DEVICE. 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) 2026, A PATIENT WAS TREATED FOR A ZONE 0 CHRONIC DISSECTION USING A PHYSICIAN MODIFIED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE DEVICE WAS MODIFIED TO CREATE FENESTRATIONS FOR THE LEFT COMMON CAROTID AND LEFT SUBCLAVIAN. IN THE PROCESS OF PERFORMING THIS MODIFICATION, THE PRIMARY SLEEVE WAS OPENED FOR A 3 CM SEGMENT ON THE SIDE OF THE DEVICE ADJACENT TO THE PORTAL. AFTER ADVANCING THE DEVICE TO THE TRANSVERSE THORACIC AORTA, THEY REALIZED THE DEVICE HAD WIRE WRAP WITH THE INNOMINATE WIRE. THEY ROTATED 2-3 TIMES COUNTER-CLOCKWISE, REALIZED THAT WAS THE WRONG DIRECTION, AND ROTATED THE OTHER WAY. AFTER 10 MINUTES, THE TBE WAS ABLE TO BE ADVANCED THROUGH THE SHEATH. ONCE IN POSITION, THEY PULLED THE DEPLOYMENT LINE. HOWEVER, THE DEVICE DID NOT DEPLOY AND REMAINED CONSTRAINED. THE PHYSICIAN TRIED TO SNARE THE PARTIALLY OPEN END OF THE TBE DEVICE, AND PULL IT BACK INTO THE DSF, BUT AFTER 45 MINUTES THEY ABANDONED THIS. THEY THEN REMOVED THE DSF AND TBE TOGETHER. THE RIGHT EXTERNAL AND COMMON ILIACS WERE DAMAGED BY THE GRAFT AND REPAIRED USING A PATCH ENDARTERECTOMY. THE PROCEDURE WAS ABORTED, AND NO DEVICES WERE IMPLANTED. THE PATIENT WOKE UP NEURO-INTACT AND IN STABLE CONDITION. THE DAMAGE TO THE ILIAC ARTERIES APPEARS TO BE THE ONLY SEQUELAE DUE TO THIS INCIDENT. THE PHYSICIAN ATTRIBUTES THE SEVERED DEPLOYMENT LINE DUE TO THE EXCESSIVE ROTATION REMOVING THE WIRE WRAP. THE PHYSICIANS NOTICED THAT THE DEPLOYMENT LINES LOOKED FLATTENED AND FRAYED AT THE POINT THEY WERE SEVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111433 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132654208

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female