BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14959614 · Received July 8, 2022

    Report

    Report Number
    2017233-2022-03105
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    June 13, 2022
    Report Date
    July 8, 2022
    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

    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, THE PATIENT PRESENTED WITH A THORACIC AORTIC ANEURYSM AND UNDERWENT ENDOVASCULAR TREATMENT UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE ENDOPROSTHESIS WAS DEPLOYED FROM A POSITION WHERE THE STENT WAS COVERING APPROXIMATELY 3 MM OF THE LEFT SUBCLAVIAN ARTERY. ANGIOGRAPHY AFTER IMPLANTATION SHOWED SLOW BLOOD FLOW INTO THE LEFT SUBCLAVIAN ARTERY, BUT THE ARTERY WAS STILL PATENT. IMAGING AFTER BALLOONING REVEALED THE LEFT SUBCLAVIAN ARTERY WAS NO LONGER PATENT. SINCE BLOOD FLOW VIA THE VERTEBRAL ARTERY WAS CONFIRMED AND THERE WAS VIRTUALLY NO DIFFERENCE IN PRESSURE BETWEEN THE LEFT AND RIGHT SIDES, NO ADDITIONAL TREATMENT WAS RENDERED. THE PATIENT TOLERATED THE PROCEDURE AND HAD NO COMPLICATIONS MOVING HIS LEFT ARM AFTER AWAKENING FROM ANESTHESIA. REPORTEDLY, THE LENGTH OF THE PROXIMAL NECK WAS SHORT, APPROXIMATELY 15 MM, AND THE NECK WAS ANGLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827003 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 62 YR Male