BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 19767371 · Received July 17, 2024

    Report

    Report Number
    2017233-2024-05115
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 3, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: CORRECTION.

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS STATES: POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: DISSECTION, PERFORATION, OR RUPTURE OF THE AORTIC VESSEL AND SURROUNDING VASCULATURE, REOPERATION / REINTERVENTION 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.

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING THORACOABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT WAS SHOWING SIGNS OF DELIRIUM. HER PRESSURE WAS UNCONTROLLED, AND THEY WERE HAVING PROBLEMS WITH THE PRESSORS, MEDICATIONS AND THE POST OP CARE. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED SHE HAD A CLEAR TEAR AND DISSECTION AT THE LEFT SUBCLAVIAN ARTERY (LSA) WHICH EXTENDED DISTALLY; WITH THE FALSE LUMEN BEGINNING TO ENCROACH AND COMPROMISE THE PROXIMAL END OF THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE PATIENT UNDERWENT REINTERVENTION USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) WHICH WAS IMPLANTED TO TREAT THE DISSECTION OF THE LSA AND A CTAG WAS USED AS A BRIDGE TO CONNECT TO THE TAMBE DEVICE. CTA SHOWED GOOD RESULTS. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE DISSECTION, AS THE INDEX PROCEDURE HAD BEEN TECHNICALLY SUCCESSFUL ALL THE WAY AROUND. HOWEVER, AS THERE WAS A LOT OF MANIPULATION THROUGH THE LSA AND THE PATIENT REPORTED TO HAVE HAD A PRETTY CALCIFIED ARCH WHICH MAY HAVE DISTURBED SOMETHING THAT CONTRIBUTED TO THE DISSECTION. THE PATIENT IS ACTUALLY DOING FINE THIS MORNING BUT SHE'S STILL INTUBATED AND VERY SEDATE BECAUSE THEY WANT TO GET HER PRESSURES BACK TO NORMAL AND KEEP HER ON A MAP OF 80 FOR LIKE A SOLID DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355389 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 80 YR Female Required Intervention| H| L| O