BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18746250 · Received February 21, 2024

    Report

    Report Number
    2017233-2024-04638
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    February 2, 2024
    Report Date
    February 21, 2024
    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

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D12: ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: AORTIC EXPANSION. 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 FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). ON UNKNOWN DATE, A TREND OF ENLARGEMENT OF A VESSEL AROUND DISTAL END OF THE CTAGAC WAS OBSERVED AND A BACK PAIN WAS DEVELOPED. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). THE DSF WAS USED FROM A LEFT ACCESS. AFTER A STENT GRAFT WAS IMPLANTED, AN ACCESS ANGIOGRAPHY REVEALED AN ACCESS VESSEL DAMAGE. ADDITIONALLY A STENT GRAFT WAS IMPLANTED AT THE DAMAGED VESSEL. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE ENLARGEMENT OF THE VESSEL MAY HAVE BEEN CAUSED BY LANDING THE DISTAL END OF THE CTAGAC ON THE AREA THAT WAS ON VERGE OF BECOMING ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630122 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 Female Required Intervention