BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17378999 · Received July 24, 2023

    Report

    Report Number
    2017233-2023-04139
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 24, 2023
    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

    H.6. TYPE OF INVESTIGATION CODE B14: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. TYPE OF INVESTIGATION CODE B20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. H.6. INVESTIGATION CONCLUSIONS CODE D1101: ACCORDING TO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT INSTRUCTIONS FOR USE (IFU), CARE SHOULD BE TAKEN NOT TO COVER THE ORIGIN OF ANY MAJOR ARTERIAL BRANCHES IN THE VICINITY OF THE TREATMENT AREA WITH ANY PORTION OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT, INCLUDING THE PARTIALLY UNCOVERED STENT. FURTHERMORE, THE IFU STATES "ENSURE THE DEVICE IS POSITIONED AGAINST THE OUTER CURVE OF THE AORTA USING FORWARD PRESSURE ON THE GUIDEWIRE." 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) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC PSEUDOANEURYSM USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAGAC). A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT COMMON FEMORAL ARTERY BUT COULD NOT ADVANCE THROUGH THE IMPLANTED VASCULAR GRAFT. THE SHEATH WAS RE-INSERTED FROM THE LEFT COMMON FEMORAL ARTERY. THOUGH THERE WAS RESISTANCE, INSERTION WAS SUCCESSFUL. AFTER INITIALLY DEPLOYING THE DISTAL CTAGAC, THE PHYSICIAN WENT TO IMPLANT THE PROXIMAL CTAGAC. IT WAS PLANNED TO PLACE THE CTAGAC IN A POSITION WHERE IT COVERED THE LEFT SUBCLAVIAN ARTERY ABOUT HALFWAY. HOWEVER, AFTER DEPLOYMENT THE LEFT SUBCLAVIAN ARTERY WAS COVERED ABOUT 80% BY THE CTAGAC. THE ANGIOGRAPHY SHOWED DECREASED BLOOD FLOW INTO THE LEFT SUBCLAVIAN ARTERY. AS A TREATMENT, A BARE METAL STENT WAS IMPLANTED IN THE LEFT SUBCLAVIAN ARTERY AND THE PROCEDURE WAS COMPLETED. REPORTEDLY THERE WAS A SPACE AT THE AORTIC OUTER CURVATURE. THE PHYSICIAN HAD ASSUMED THAT THE DEVICE WOULD MOVE INTO THE SPACE ON ITS DEPLOYMENT, SO HE DEPLOYED THE DEVICE MORE ON THE PROXIMAL SIDE, BUT THE DEVICE DID NOT MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599378 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 75 YR Female Other