BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 22093515 · Received May 28, 2025

    Report

    Report Number
    2017233-2025-06240
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    April 7, 2025
    Report Date
    June 6, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    04993024008281
    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

    D12: ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: DISSECTION, PERFORATION, OR RUPTURE OF THE AORTIC VESSEL & SURROUNDING VASCULATURE. 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

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR TYPE B AORTIC DISSECTION USING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG). ON AN UNKNOWN DATE, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) IMAGING CONFIRMED A REDUCTION IN THE FALSE LUMEN. ON (B)(6) 2025, FOLLOW-UP CT IMAGING REVEALED A NEW DISTAL STENT-INDUCED ENTRY (DSINE) AT THE DISTAL END OF THE CTAG. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION, DURING WHICH AN ADDITIONAL STENT GRAFT WAS DEPLOYED DISTALLY. PHYSICIAN¿S COMMENT: UNTIL ONE YEAR AGO, FOLLOW-UP CT SCANS SHOWED A REDUCTION IN THE FALSE LUMEN. AS THE FALSE LUMEN THROMBOSED AND WAS GRADUALLY ABSORBED, IT EXTENDED TOWARD A HIGHLY ANGULATED SEGMENT OF THE AORTA. THIS LIKELY CAUSED MECHANICAL STRESS AT THE EDGE OF THE STENT GRAFT, RESULTING IN THE DEVELOPMENT OF A SINE. THIS IS PRESUMED TO BE RELATED TO THE PATIENT¿S ANATOMICAL CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329366 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 04993024008281

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention