BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 21844013 · Received April 15, 2025

    Report

    Report Number
    3007284313-2025-03903
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    September 27, 2024
    Report Date
    June 17, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED G3. B3: CORRECTED THE DATE. 'DATE OF EVENT' IS CHOSEN AS FROM THE IMAGING DATA (PROVIDED TO GORE) AND IT WAS SEEN THAT RIIA EXPANSION AT THE SITE OF THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS OCCURRED. THIS WAS THE FIRST TIME OF ANEURYSM ENLARGEMENT, THEREFORE THE ONSET DATE 9/27/2024 IS THE DATE OF INCIDENT. B5: 'DESCRIBE EVENT OR PROBLEM', ADD RELEVANT INFORMATION AS WE RECEIVED FURTHER EVENT INFORMATION. H6: TYPE OF INVESTIGATION, CODE B14 ADDED. INVESTIGATION CONCLUSIONS, CODE D1001 ADDED. D16 NO LONGER APPLICABLE. INVESTIGATION FINDINGS, CODE C19 ADDED. C21 NO LONGER APPLICABLE. MEDICAL DEVICE PROBLEM CODE, CODE A050408 ADDED. A24 NO LONGER APPLICABLE. TO INVESTIGATION FINDINGS & CONCLUSIONS BY GORE (FOR CODE 'C19' AND 'D1001' SELECTED): PHR - A UNIQUE DEVICE IDENTIFICATION NUMBER WAS PROVIDED; THEREFORE, A PRODUCT HISTORY REVIEW COULD BE PERFORMED FROM THE MANUFACTURING RECORDS. THE MANUFACTURING ENGINEER HAS CONFIRMED THAT THE FOLLOWING RECORDS WERE REVIEWED, THIS COMPLAINT WAS REVIEWED TO: LOT 7736864 (24178351, 24178354). A REVIEW OF THE MANUFACTURING RECORDS INDICATE THAT LOT 7736864 (24178351, 24178354) MET PRE-RELEASE SPECIFICATIONS. IMAGING EVALUATION OBSERVED DISTAL MIGRATION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, BUT THERE WERE NO OBSERVATIONS CONFIRMING MIGRATION OR SEALING IN RELATION TO THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ANEURYSMAL GROWTH OF THE INTERNAL ILIAC ARTERY WAS CONFIRMED OVER THE 26 MONTHS OF AVAILABLE IMAGING DATA. THE PRODUCT ITSELF WAS NOT RETURNED FOR EVALUATION. SUMMARY: THIS COMPLAINT WAS INITIATED BASED ON INFORMATION RECEIVED FROM THE FIELD. THE INFORMATION REPORTED IN THE COMPLAINT, INCLUDING RETURNED CLINICAL IMAGES, DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED. THE REPORTED DISTAL DEVICE MIGRATION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT TRUNK) AND LOSS OF SEAL ARE ATTRIBUTED TO ANEURYSM GROWTH IN THE RIGHT INTERNAL ILIAC ARTERY AS REPORTED. ANEURYSM GROWTH REPRESENTS A KNOWN COMPLICATION OR ADVERSE EVENT THAT CAN OCCUR WHEN USING THE DEVICE. IFU (INSTRUCTIONS FOR USE) STATEMENTS, REVIEWED THE APPLICABLE IFU FOR GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WITH RESPECT TO THE COMPLAINT DETAIL FOR THE APPLICABLE REGION AND TIME PERIOD, AND THE FOLLOWING IFU STATEMENTS WERE IDENTIFIED IN RELATION TO THE COMPLAINT. ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM ENLARGEMENT, ENDOLEAK.

    Additional Manufacturer Narrative · 0

    H3: NO DEVICE IS BEING RETURNED FOR EVALUATION. H6: C21, D15: INVESTIGATION IS NOT CONCLUDED YET. DUE TO MISSING SERIAL WE HAVE LIMITED INFORMATION ABOUT DEVICE. THE SERIAL NUMBER REMAINS UNKNOWN, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. B13: FURTHER INTERVIEWS ABOUT THE PATIENT DISEASE PROGRESSION HAS BEEN DONE. THE REASON FOR EXPLANT WAS THE ANEURYSM SAC ENLARGEMENT DUE TO A DISEASE PROGRESSION. FROM THE GORE DEVICES USED IN THIS PATIENT IT WAS REPORTED ALSO ANOTHER GORE DEVICE, WITH THE TRUNK (GORE® EXCLUDER® AAA ENDOPROSTHESIS) MIGRATED DISTALLY, THE CONCLUSION WILL BE TABLED ONCE INVESTIGATION CAN BE COMPLETED. CLINICAL IMAGES ARE EVALUATED BY GORE. THE EXPLANT DATE REMAINS UNKNOWN. 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

    UPDATED G3. TYPE OF INVESTIGATION, CODE B17 ADDED. PENDING INVESTIGATION CONCLUSIONS AS STILL ONGOING INVESTIGATION BY MANUFACTURER TO CONCLUDE THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE, THAT ON AN UNKNOWN DATE IN (B)(6) 2022, A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) WHERE BOTH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WERE IMPLANTED AT ABERDEEN ROYAL INFIRMARY. DURING A FOLLOW-UP WITH IMAGING OF THE PATIENT (THE DATA WAS DATED BY TIMEPOINT OF SEPTEMBER 27, 2024), THERE WAS A DISTAL MIGRATION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT TRUNK) CONFIRMED WHICH RESULTED IN AN ENDOLEAK AND SAC ENLARGEMENT. THE PATIENT WAS REFERRED TO EDINBURGH ROYAL INFIRMARY FOR DEVICE EXPLANT AND SURGICAL REPAIR. ALL GORE® EXCLUDER® DEVICES WERE EXPLANTED ON (B)(6) 2025. IT WAS ADDITIONALLY REPORTED THAT THE CLINICIANS AT BOTH HOSPITALS AGREED THAT THE CAUSE OF THE EXPLANT IS DUE TO THE CONTINUED RIGHT INTERNAL ILIAC ARTERY EXPANSION (AT THE SITE OF THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS), WHICH LED TO THE DOWNWARD MIGRATION OF THE MAIN GRAFT (GORE® EXCLUDER® AAA ENDOPROSTHESIS). THE LEAD CLINICIAN AT EDINBURGH ROYAL INFIRMARY ALSO COMMUNICATED TO THE GORE REPRESENTATIVE THAT THERE IS NOTHING WRONG WITH THE GRAFT AND THAT HE HAS NO CONCERN WITH GORE PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT ON AN UNKNOWN DATE IN (B)(6) 2022 THIS PATIENT UNDERWENT A PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). ON AN UNKNOWN DATE, FOLLOW-UP IMAGING REPORTEDLY SHOWED DISTAL MIGRATION OF THE IPSILATERAL TRUNK RESULTING IN AN ENDOLEAK AND SAC ENLARGEMENT. THE EXACT ANEURYSM SAC GROWTH IS UNKNOWN. THE PHYSICIAN REPORTEDLY BELIEVES THAT THE REASON FOR THE MIGRATION IS LIKELY DISEASE PROGRESSION. THE PHYSICIAN HAS PLANNED A REINTERVENTION FOR DEVICE EXPLANT. THERE IS NO EXPLANT DATE AS OF YET. NO PATIENT HARM REPORTED FROM INITIAL INFORMATION. ON (B)(6) 2025, THE INFORMATION CAME THAT EXPLANT SURGERY WAS SCHEDULED AND NEED TO GET THE FINAL ANGIOGRAPHY AFTER EXPLANT TO SEE THE DISEASE PROGRESSION OR ANY FURTHER DISEASE. REPORTEDLY, THE PHYSICIAN HAD COMMENTED THAT ALL EXCLUDER DEVICES, INCLUDING IBE HAVE BEEN EXPLANTED IN THIS OPEN SURGICAL REPAIR. AND THAT THE CAUSE OF THE MIGRATION WAS THAT THE INTERNAL ILIAC ARTERY, THAT HAD THE IBE IN IT, HAD UNDERGONE SIGNIFICANT DISEASE PROGRESSION, CAUSING ALL OF THE JOINED GRAFTS TO MIGRATE DISTALLY RESULTING IN COMPLETE LOSS OF SEAL AND ANEURYSM EXCLUSION, WITH THE SAC BEING UNDER PRESSURE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105517 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other