BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 20020985 · Received August 21, 2024

    Report

    Report Number
    2017233-2024-05238
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 19, 2024
    Report Date
    September 22, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    UDI-DI
    00733132659685
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICES INCLUDED ON THIS REPORT ARE AS FOLLOWS: CATALOG #PLC231400/ SERIAL (B)(6) / UDI (B)(4). CATALOG #CEB231410A/ SERIAL (B)(6)/ UDI (B)(4). CATALOG #MOB37/ SERIAL (B)(6) / UDI (B)(4). A.4. PATIENT WEIGHT: ASKED BUT UNAVAILABLE. B.7. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: ASKED BUT UNAVAILABLE. D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE. H.6. TYPE OF INVESTIGATION: CODE B15 - IMAGES WERE PROVIDED, AND AN IMAGING EVALUATION WILL BE PERFORMED. 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

    H.6. INVESTIGATION FINDINGS FOR ANALYSIS OF PRODUCTION RECORDS: CODE C19 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION FINDINGS FOR IMAGING EVALUATION: CODE C19 - THE IMAGING EVALUATION, PERFORMED BY A CLINICAL IMAGING SPECIALIST, REPORTED THAT ONE TIME POINT WAS AVAILABLE FOR EVALUATION: PRE-IMPLANTATION CTA DATED ON (B)(6) 2024. PROXIMAL LANDING ZONE (45MM ¿ 85MM PROXIMAL TO THE CELIAC ARTERY) DIAMETERS APPEARED TO BE: ~DTA @ 45MM PROXIMAL TO CELIAC ¿ 32.4MM, ~DTA @ 65MM PROXIMAL TO CELIAC ¿ 33.9MM, ~DTA @ 85MM PROXIMAL TO CELIAC ¿ 34.7MM. ALL DIAMETERS WITHIN THE PROXIMAL LANDING ZONE HAD CIRCUMFERENTIAL THROMBUS UP TO 4.8MM IN THICKNESS. THROMBUS WAS PRESENT THROUGHOUT THE ABDOMINAL AORTA AND EXTENDED INTO THE COMMON ILIAC ARTERIES, ESPECIALLY THE RIGHT COMMON ILIAC. THE IMAGES PROVIDED DID NOT ALLOW FOR EVALUATION IN RELATION TO THE POST-IMPLANTATION REPORTED COMPLAINT. H.6. INVESTIGATION CONCLUSIONS: CODE D15 - THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. H.6. INVESTIGATION CONCLUSIONS: CODE D12 ADDED. ACCORDING TO THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE, POTENTIAL DEVICE AND PROCEDURE-RELATED ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS, OR IN ANY ENDOVASCULAR REPAIR PROCEDURE, WHICH MAY OR MAY NOT REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE, PARAPLEGIA, PARAPARESIS, NUMBNESS, SPINAL CORD ISCHEMIA, TRANSIENT ISCHEMIC ATTACK). H.6. INVESTIGATION FINDINGS FOR ANALYSIS OF PRODUCTION RECORDS: CODE C21 UPDATED TO CODE C19. H.6. INVESTIGATION FINDINGS FOR IMAGING EVALUATION: CODE C21 UPDATED TO CODE C19. H.6. INVESTIGATION CONCLUSIONS: CODE D16 UPDATED TO CODE D15.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES (TAMBE) DEVICE SYSTEM. A TAMBE AORTIC COMPONENT, GORE® EXCLUDER® ILIAC BRANCH COMPONENT, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WERE IMPLANTED. A GORE® MOLDING & OCCLUSION BALLOON CATHETER WAS ALSO USED AS AN ACCESSORY. IT WAS NOTED THAT MURAL THROMBUS WAS PRESENT IN THE PATIENT'S AORTA. ON JULY 22, 2024, THE GORE REPRESENTATIVE BECAME AWARE THAT THE PATIENT HAD DEVELOPED PARALYSIS IN THEIR ARMS AND LEGS ON (B)(6) 2024. THE MURAL THROMBUS WAS SUSPECTED TO HAVE CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT THE PATIENT'S ARMS RECOVERED FULLY ON AN UNKNOWN DATE AND THEIR LEGS REGAINED SENSATION, BUT NO MOTOR FUNCTION. ON (B)(6) 2024, THE PATIENT WAS PLACED ON COMFORT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118070 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC. 00733132659685

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Disability| O