BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21321709 · Received February 6, 2025

    Report

    Report Number
    2017233-2025-05807
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 12, 2025
    Report Date
    March 5, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INITIAL REPORTER HAS BEEN CONTACTED IN ORDER TO RECEIVE MORE INFORMATION ON THE EVENT AND PATIENT DETAILS. 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. 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

    D10: CONCOMITANT MEDICAL PRODUCTS: (RELEVANT ASSOCIATED DEVICES USED WITH THE DEVICE BEING REPORTED ON): GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC123415E, TSB121506E). H6: UPDATED INVESTIGATION FINDINGS CODE TO C19, CODE C21 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D15 AND D12, CODE D16 IS NO LONGER APPLICABLE. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE BUT ARE NOT LIMITED TO: NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE, PARAPLEGIA, PARAPARESIS).

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT UNDERWENT AN EMERGENCY PROCEDURE IN ZONE 0 DUE TO A CONTAINED RUPTURED THORACIC ANEURYSM DISTAL TO THE BRACHIOCEPHALIC TRUNK (BCT) AND WAS TREATED WITH AN OPEN BYPASS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED IN THE SAME SESSION. THE PATIENT REMAINS CURRENTLY INTUBATED ON (B)(6) 2024 AS HE MIGHT HAVE SUFFERED A STROKE (EXACT TIME UNKNOWN AS NOT CONFIRMED BY THE MRI REPORT WHETHER THIS MIGHT HAVE BEEN ACUTE OR NOT). IT APPEARS THAT THE AREA OF INTEREST IS MOSTLY LOCATED IN THE LEFT PART OF THE BRAIN. THE PHYSICIAN REPORTED THAT THE PATIENT WILL MAKE GOOD RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531814 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 NA Male Other GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS.| SEE H10.