BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 14379963 · Received May 12, 2022

    Report

    Report Number
    2017233-2022-02921
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    January 1, 2021
    Report Date
    May 12, 2022
    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

    (B)(4). IT SHOULD BE NOTED THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATE ¿COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO, DISSECTION, PERFORATION, OR RUPTURE OF THE AORTIC VESSEL & SURROUNDING VASCULATURE, AORTIC EXPANSION (E.G., ANEURYSM, FALSE LUMEN, LANDING ZONE, LESION), AND REOPERATION.¿ 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

    ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A CHRONIC TYPE B AORTIC DISSECTION USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. A 45MM X 20CM GORE® TAG® DEVICE WAS IMPLANTED DISTALLY, AND A 45MM X 10MM DEVICE WAS IMPLANTED PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN 2021, A DISTAL STENT GRAFT-INDUCED NEW ENTRY TEAR WAS REPORTEDLY IDENTIFIED DURING A FOLLOW-UP EXAMINATION. ACCORDING TO THE REPORT, DEVICE SIZE WAS DETERMINED BASED ON THE PROXIMAL AORTIC DIAMETER DURING THE INDEX PROCEDURE; AS A RESULT, THE DEVICE MAY HAVE BEEN TOO LARGE FOR THE DISTAL LANDING SITE (MEASUREMENT OF DISTAL THORACIC AORTIC DIAMETER AT THE TIME OF INDEX PROCEDURE WAS NOT AVAILABLE). ON AN UNKNOWN DATE IN (B)(6) 2022, A FOLLOW-UP EXAMINATION REPORTEDLY SHOWED AORTIC EXPANSION (MEASUREMENTS NOT PROVIDED). ON (B)(6) 2022, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED DISTAL TO THE EXISTING STENT GRAFTS SYSTEM TO COVER THE ENTRY TEAR. A 34MM X 10CM DEVICE WAS PLACED APPROXIMATELY 2 CM DISTAL TO THE PREVIOUS DEVICE, AND A 45MM X 20CM DEVICE WAS PLACED AS A BRIDGE BETWEEN THE PREVIOUS DEVICE AND THE NEW ONE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617822 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H