BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21298819 · Received February 3, 2025

    Report

    Report Number
    2017233-2025-05792
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 6, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646838
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. PATIENT PREEXISTING MEDICAL HISTORY/TREATMENT: DIALYSIS. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ¿ ONE TIME-POINT IS AVAILABLE FOR EVALUATION: POST-IMPLANTATION NON-CONTRAST CT. ¿ CANNOT CONFIRM AN ENDOLEAK WITHOUT CONTRAST. ¿ AORTIC DIAMETER JUST DISTAL TO THE LEFT RENAL ARTERY APPEARS TO BE 37.2MM. ¿ THERE APPEARS TO BE LACK OF PROXIMAL CIRCUMFERENTIAL DEVICE APPOSITION. CANNOT CONFIRM A PROXIMAL TYPE I ENDOLEAK WITHOUT CONTRAST, AS STATED ABOVE. ¿ THE LENGTH FROM THE RENAL ARTERY TO THE PROXIMAL CIRCUMFERENTIAL GORE® EXCLUDER® AAA ENDOPROSTHESIS APPEARS TO BE ~7.8CM, BY OUTER CURVE LENGTH. ¿ THE LENGTH FROM THE RENAL ARTERY TO THE PROXIMAL CIRCUMFERENTIAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM APPEARS TO BE ~4.2CM, BY OUTER CURVE LENGTH. IMAGING SHOWS THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT IS 10CM IN LENGTH. ¿ MAXIMUM ABDOMINAL AORTIC ANEURYSM (AAA) DIAMETER APPEARS TO BE 61.9MM X 69.1MM. ¿ NO AORTIC EXTENDERS ARE PRESENT ON THE IMAGING PROVIDED. ¿ CANNOT CONFIRM A RUPTURE.

    Additional Manufacturer Narrative · 0

    H6: CODE C21 - RESULTS PENDING COMPLETION OF PRODUCT HISTORY REVIEW. H6: CODE C20 - THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. H6: CODE A26-USED TO CAPTURE INSUFFICIENT INFORMATION AVAILABLE IN REGARD TO CAUSE OF ANEURYSM RUPTURE. IT SHOULD BE NOTED THAT, PER THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, AORTIC RUPTURE. 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) 2022, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE, TO TREAT AN ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351414 AND PLL161407) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (TGMR404010) WAS ALSO IMPLANTED PROXIMALLY AS WELL. ON (B)(6)2025, PATIENT PRESENTED WITH A RUPTURED ANEURYSM. AN TYPE 1A ENDOLEAK WAS ALSO IDENTIFIED ON TGMR404010 DEVICE. ON (B)(6)2025, PATIENT UNDERWENT A REINTERVENTION SURGERY IN WHICH EXCLUDER CONFORMABLE AORTIC EXTENDERS WERE IMPLANTED. PHYSICIAN COVERED THE RENALS WITH AORTIC EXTENDERS INTO THE PREVIOUS TRUNK. NO ENDOLEAK WAS NOTED AFTER THE PROCEDURE. THE EXACT LOCATION OF RUPTURE IS UNKNOWN. PHYSICIAN DOES NOT KNOW WHAT CAUSED THE RUPTURE, BUT BELIEVES IT WAS A RESULT FROM PROXIMAL TYPE 1A ENDOLEAK. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039945 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132646838

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention