BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 23565445 · Received November 16, 2025

    Report

    Report Number
    2017233-2025-06829
    Event Type
    Malfunction
    Date Received
    November 16, 2025
    Date of Event
    November 12, 2025
    Report Date
    February 6, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132644353
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HISTORY REVIEW AND REVIEW OF THE PROVIDED PICTURES IS ONGOING. ENGINEERING EVALUATION OF THE DEVICE IS ANTICIPATED (DEVICE CURRENTLY IN TRANSIT). 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.

    Additional Manufacturer Narrative · 0

    UPDATED D9 AND H3. UPDATED H6: REMOVED MEDICAL DEVICE PROBLEM CODE A050705 AS IT WAS INADVERTENTLY ENTERED. ADDED TYPE OF INVESTIGATION CODE B01 AND B19. UPDATED INVESTIGATION FINDINGS CODE TO C070601, CODE C21 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D15, CODE D16 IS NO LONGER APPLICABLE. AS PART OF OUR ROUTINE QUALITY PROCEDURES, EACH BATCH OF DEVICES UNDERGOES COMPREHENSIVE QUALITY CONTROL TESTING AND INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. GORE REVIEWED THE MANUFACTURING RECORDS ASSOCIATED WITH THE REPORTED LOT NUMBER AND VERIFIED THAT ALL RELEASE CRITERIA HAD BEEN MET. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) STENT GRAFT REMAINS IMPLANTED; HOWEVER, PART OF THE DEPLOYMENT HANDLE AND DEPLOYMENT LINE WAS RETURNED TO GORE FOR EVALUATION, AND THE EVALUATION SHOWED THE FOLLOWING: A PORTION OF THE SECONDARY DEPLOYMENT LINE (SDL) WAS RETURNED WITHOUT THE SDL HANDLE. THE SPINE ASSEMBLY, WHITE HANDLE COVERS, LOWER AND UPPER MANIFOLD HALVES WERE ALSO RETURNED SEPARATED FROM EACH OTHER. NO OTHER HANDLE COMPONENTS OR DEPLOYMENT FIBERS WERE RETURNED. SECONDARY DEPLOYMENT NOT OCCURRING IS LIKELY DUE TO THE SECONDARY DEPLOYMENT LINE BREAKING. THE RETURNED SECTION OF DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO TENSILE FORCES. THIS IS SUPPORTED BY THE FRAYED ENDS OF THE FIBER, AND THE OUTER WRAP OF THE FIBER BEING PRESENT AT THE BREAK WITHOUT THE CORE. THE MANIFOLD AND CATHETER WERE INSPECTED TO CONFIRM NO EVIDENCE OF MISROUTED AND/OR PINCHED FIBER. IT CANNOT BE CONFIRMED WHAT PORTION OF THE SDL WAS RETURNED AND SO NOTHING CAN BE CONCLUDED ABOUT THE DEPLOYMENT OF THE SDL, OTHER THAN THAT THE RETURNED PORTION APPEARS TO HAVE BROKEN DUE TO TENSILE FORCES. THE CAUSE OF THE SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. BASED ON THE EVENT DESCRIPTION AND THIS INVESTIGATION, NO MANUFACTURING DEFICIENCIES COULD BE CONFIRMED. NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE, THAT ON (B)(6) 2025, A PATIENT WITH A THORACOABDOMINAL AORTIC ANEURYSM (TAAA) UNDERWENT AN ELECTIVELY PLANNED THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) WAS SELECTED FOR THE IMPLANT, WHICH SHOULD LAND APPROXIMATELY 4 CM DISTAL OF LEFT SUBCLAVIAN ARTERY AND 4 CM PROXIMAL THE CELIAC TRUNK AND STILL HAVE APPROPRIATE SEALING LENGTH. THE DEVICE WAS INTRODUCED IN PLACE, AND THE FIRST STEP OF DEPLOYMENT WAS SUCCESSFUL, FOLLOWED BY THE SECOND STEP OF DEPLOYMENT, AND THAN QUICKLY THE THIRD AND THE FOURTH. THE OPTIONAL ANGULATION WAS NOT USED. WHAT THE PHYSICIAN DID NOT OBSERVE, WAS THAT DURING THE SECOND DEPLOYMENT STEP, THE DEPLOYMENT LINE DID NOT COME OUT OF THE HANDLE. SO, THE DEVICE WAS RELEASED, BUT THE SECONDARY SLEEVE WAS STILL CONSTRAINING THE DEVICE, KEEPING IT AT ITS INTERMEDIATE DIAMETER. THE DEVICE STAYED IN POSITION; THE DEPLOYMENT HATCH WAS OPENED TO RETRACT THE DEPLOYMENT LINE THERE. DUE TO TENSION, THE LINE BROKE IN THE HATCH. THE PHYSICIAN TRIED TO OPEN THE WHOLE DELIVERY CATHETER TO REACH FOR THE DEPLOYMENT LINE, BUT THAT WAS NOT POSSIBLE. A GORE® TRI-LOBE BALLOON CATHETER WAS USED IN ORDER TO OPEN THE DEVICE TO ITS FULL DIAMETER (FIRST DISTALLY, WORKING THEIR WAY UP TO PROXIMAL). ON THE PROXIMAL END IT WAS NOT POSSIBLE TO OPEN THE DEVICE COMPLETELY. THE DEVICE LOST SEAL DURING THIS MANIPULATION AND MIGRATED DISTALLY (DISTANCE UNKNOWN, BUT WITHOUT ANY VESSEL COVERAGE). A SECOND CTAG DEVICE WAS USED AS EXTENSION AND TO ACHIEVE PROXIMAL SEAL. THE GORE® TRI-LOBE BALLOON CATHETER WAS USED AGAIN, BUT WITH NO SUCCESS. A 30 MM HIGH PRESSURE BALLOON (NUCLEUS¿) WAS USED AND SUCCESSFULLY OPENED UP THE PROXIMAL PART OF THE FIRST CTAG TO 100% ITS DIAMETER. UNFORTUNATELY, THE DEPLOYMENT LINE WAS STILL STUCK ON THE SECONDARY SLEEVE. THE PHYSICIANS WERE ABLE TO BREAK THE LINE JUST DISTALLY OF THE GRAFT BY PUTTING A 8 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON IN A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH AND PULLED HARD WITHOUT MIGRATING THE DEVICES. THE DEPLOYMENT LINE CAME OUT SUCCESSFULLY AND THE FINAL ANGIOGRAPHY SHOWED SUCCESSFUL EXCLUSION OF THE TAAA. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296345 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132644353

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female