BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21001793 · Received December 23, 2024

    Report

    Report Number
    2017233-2024-05652
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 26, 2024
    Report Date
    April 22, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED B2, G3/G4. H1/H2, H3, H6. THE DEVICE EVALUATION SHOWED THE FOLLOWING: A FULL DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE AND IMAGES WERE NOT RETURNED. NO ROOT CAUSE OF THE INVAGINATION OF THE DEVICE COULD BE CONFIRMED. NO MANUFACTURING DEFICIENCY WAS IDENTIFIED DURING THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    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 FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN ZONE 5. IT WAS REPORTED THAT GORE® TRI LUMEN CATHETER (TLC) WAS DAMAGED. THE GREY TUBE ON THE DISTAL TLC BROKE UPON REMOVING IT FROM PACKAGING/SLEEVE/TRAY. THE SCRUB TECH GRABBED THE DISTAL END OF THE CATHETER AND BENT IT. ANOTHER TLC WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT THE DRY SEAL SHEATH (DSF1233) FROM THE RIGHT AXILLARY CAUSED THE PROXIMAL END OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) TO INVAGINATE. IT WAS DETERMINED TO ADD ANOTHER CTAG ON TO COVER IT. THE LENGTH OF THE CATHETER WAS AT ITS LIMIT (HUBBED TO THE PATIENT¿S ARMPIT) AT THE SAME LEVEL OF THE TOP OF THE CTAG. THUS, PUSHING THE TOP OF THE CTAG DOWN. THERE WAS NO VESSEL COVERAGE. THE PATIENT HAD A TORTUOUS AORTA. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN BELIEVES THAT INVAGINATION OF THE CTAG WAS DUE TO A COMBINATION OF THE TORTUOUS AORTA WITH THE CTAG AROUND THE BEND AND THE LENGTH OF THE DSF1233 PUSHING ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617796 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention