BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 19832000 · Received July 25, 2024

    Report

    Report Number
    2017233-2024-05146
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 23, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    UDI-DI
    00733132659678
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT DURING THE PROCEDURE A ROSEN WIRE (BOSTON SCIENTIFIC PRODUCT) WAS BEING USED IN THE LEFT RENAL ARTERY, DURING THIS ATTEMPT THE WIRE PERFORATED THE LEFT RENAL ARTERY. THE PHYSICIAN CHOSE TO COIL EMBOLIZE THE LEFT RENAL ARTERY. THE PHYSICIAN COULD NOT CANNULATE THE CELIAC ARTERY AFTER MULTIPLE ATTEMPTS (WIRE BEING USED IS UNKNOWN). THE PHYSICIAN CHOSE NOT TO IMPLANT A GORE® VIABAHN® DEVICE, THE PORTAL REMAINED OPEN, AND THE CELIAC ARTERY WAS STILL GETTING PROFUSION. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188046 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC. 00733132659678

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization