BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 16992857 · Received May 24, 2023

    Report

    Report Number
    2017233-2023-03958
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 5, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132654093
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 SPECIFICATIONS. ACCORDING TO THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO DISSECTION AND REOPERATION. ADDED IMAGING EVALUATION SUMMARY: THE IMAGES RECEIVED CANNOT BE USED TO PERFORM A FULL IMAGING EVALUATION. THE EXTENT AND ACCURACY OF THE OBSERVATIONS AND FINDINGS MAY BE LIMITED DUE TO THE COMPLETENESS, FORMAT AND/OR QUALITY OF THE AVAILABLE IMAGES PROVIDED FOR REVIEW. GORE CANNOT GUARANTEE THE IMAGES PROVIDED ARE ACCURATE OR LACK ALTERATION. THEREFORE, GORE CANNOT GUARANTEE ALL KEY FINDINGS HAVE BEEN CAPTURED OR THAT THE FINDINGS ARE ACCURATE. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: TWO JPEG IMAGES AND 2 MOVIE FILES SUBMITTED FOR EVALUATION. NO NAME OR DEMOGRAPHICS ON IMAGES PROVIDED. A JPEG IMAGE ENTITLED, ¿FINAL ANGIO ON INITIAL IMPLANT OF TBE¿, SHOWS CONTRAST IN THE BRACHIOCEPHALIC ARTERY AND AT THE PROXIMAL IMPLANTED DEVICE IN THE THORACIC AORTA. WITH THE AMOUNT OF CONTRAST FILLING ON THE IMAGE, CANNOT CONFIRM IF THERE IS A DISSECTION IN THE ASCENDING THORACIC AORTA AT TIME OF IMAGE ACQUISITION. "VIDEO.MOV AXIALS 5-1-2023 CASE #13790 (1)¿ IMAGES SHOW: A DISSECTION IS OBSERVED IN THE ASCENDING THORACIC AORTA ON THIS VIDEO. ¿VIDEO.MOV SAGITALS 5-1-2023 CASE #(B)(4)¿ IMAGES SHOW: A DISSECTION IS OBSERVED AT THE PROXIMAL END OF THE PREVIOUSLY IMPLANTED DEVICE. THIS DISSECTION EXTENDS INTO THE BRACHIOCEPHALIC ARTERY AND ASCENDING THORACIC AORTA.

    Additional Manufacturer Narrative · 0

    CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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 WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT PRESENTED TO EMERGENCY ROOM WITH A SYMPTOMATIC TYPE B AORTIC DISSECTION, UPON WHICH PROCEDURE WAS DONE UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC083415A), GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH TSB081206A) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO EXTEND DISTALLY (TGM343415). PATIENT WAS DISCHARGED, SYMPTOMS RESOLVED WITH AN UNEVENTFUL POSTOPERATIVE COURSE. ON (B)(6) 2023, REPORTEDLY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR REINTERVENTION PROCEDURE WITH A RETROGRADE TYPE A DISSECTION, WHERE THE PROXIMAL END OF THE STENT GRAFT CLEARLY DISRUPTED THE AORTA AT THE LEVEL OF THE LEFT COMMON CAROTID IN ZONE-01 WHERE THE ASCENDING WAS DISSECTED. PATIENT RECEIVED SURGERY WITH AN OPEN ASCENDING REPAIR IN ZONE-2 ARCH WHERE THEY SEWED THE DACRON GRAFT AND BYPASSING THE HEAD VESSELS IN ORDER TO SEW DIRECTLY TO THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICE WHICH WAS PLACED PREVIOUSLY. THE PATIENT WAS COMPLAINT WITH HER FOLLOW UP, CAME IN FOR POSTOPERATIVE CT SCANS AND FOLLOW-UP APPOINTMENTS. IT IS A STENT INDUCED RETROGRADE TYPE A DISSECTION PER IMAGING SCANS DONE AT THE HOSPITAL. PROCEDURE WENT WELL AND PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949045 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TAC083415A 00733132654093

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R