BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 19899927 · Received August 2, 2024

    Report

    Report Number
    2017233-2024-05176
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    April 16, 2024
    Report Date
    August 13, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    PMA / PMN Number
    P230023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION A2, A3, AND A4-PATIENT INFORMATION. UPDATED SECTION E1-INITIAL REPORTER INFORMATION. PATIENT MEDICAL HISTORY INCLUDES: HYPOCHOLESTEROLEMIA; HYPERTENSION CORRECTED INITIAL REPORTER CITY.

    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. H6: CODE C20 - THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. PATIENT IMAGES HAVE BEEN PROVIDED. GORE IMAGING SERVICES REPORTED THE FOLLOWING: WIRE FRACTURE CONFIRMED ON THE (B)(6) 2024 TIME POINT FOR THE (B)(6) SUBJECT IMAGING. 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) 2021, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING THE INVESTIGATIONAL GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. ON (B)(6) 2024, DURING IMAGING FOLLOW-UP, WIRE FRACTURE OF THE TAMBE AORTIC COMPONENT IN THE SECOND STENT ROW DISTAL TO THE RIGHT RENAL ARTERY PORTAL GOLD RINGS WAS OBSERVED. IT IS ANTERIOR TO THE PORTAL GOLD RING IN NATURE. THERE APPEARS TO BE THREE SIDE BRANCH COMPONENTS DEPLOYED AT THE LEVEL OF THE WIRE FRACTURE. SERVED ON CTA IMAGING. NO TREATMENT WILL BE PROVIDED. THE FRACTURE WILL CONTINUE TO BE MONITORED. NO PATIENT ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371771 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other