BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 22605783 · Received July 25, 2025

    Report

    Report Number
    2017233-2025-06448
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 1, 2025
    Report Date
    July 28, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. 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

    ATTACH THE LITERATURE ARTICLE.

    Description of Event or Problem · 0

    KOBAYASHI Y, UCHIDA K, MORI K, SUZUKI K, SAITO A. "RIGHT THORACOTOMY APPROACH FOR THE MANAGEMENT OF UNCOMMON TYPE II ENDOLEAK AFTER THORACIC ENDOVASCULAR AORTIC REPAIR." JOURNAL OF VASCLAR SURGERY CASES, INNOVATIONS AND TECHNIQUES 2025;11(3):101749. THIS IS A CASE REPORT OF AN 80-YEAR-OLD MALE WITH A PSEUDOANEURYSM AFTER AORTIC DISSECTION REPAIR 6 YEARS PRIOR WHO UNDERWENT THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR). A TEVAR WAS PERFORMED WITH A 31 X 150-MM CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS SUCCESSFULLY ISOLATED THE PSEUDOANEURYSM. HE WAS DISCHARGED FROM THE HOSPITAL. OVER THE NEXT 4 YEARS, THE ANEURYSM EXPANDED UNEXPECTEDLY. THE MOST RECENT CT SCANS DEMONSTRATED AN ANEURYSM MEASURING 89 MM AXIALLY AND 85 MM CORONALLY, WITH 9 MM AND 5 MM INCREASES, RESPECTIVELY, OVER THE LAST 4 MONTHS. DETAILED EVALUATION REVEALED THE COMMON TRUNK OF THE RIGHT THIRD AND FOURTH INTERCOSTAL ARTERIES AND RIGHT BRONCHIAL ARTERY (RIGHT INTERCOSTOBRONCHIAL TRUNK/ICBT), RUNNING BETWEEN THE ESOPHAGUS AND VERTEBRAL BODY, JOINING THE LEFT BRONCHIAL ARTERY AT THE ROOT AND THIS WAS SUSPECTED TO BE THE CAUSE OF THE TYPE II ENDOLEAK. A RIGHT THORACOTOMY WAS PROPOSED TO DIRECTLY ADDRESS THE PATENT ICBT AND LEFT BRONCHIAL ARTERY. THE ORIGIN WAS SUCCESSFULLY IDENTIFIED, BIFURCATING INTO THE ICBT AND LEFT BRONCHIAL ARTERY, BOTH OF WHICH WERE SAFELY DOUBLE- CLIPPED AND DISSECTED. POSTOPERATIVE CT SHOWED DECREASED ANEURYSM SIZE AND PROPER CLIP PLACEMENT AND ANEURYSM REMAINED STABLE OVER 2 YEARS OF FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038468 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention