BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 23420778 · Received October 29, 2025

    Report

    Report Number
    3007284313-2025-04341
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 10, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132634644
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. CODE C19: A REVIEW OF THE MANUFACTURING RECORDS OF THE DEVICE INDICATED THE LOT MET ALL THE PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS EXPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. PLEASE NOTE THAT GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC121000/ (B)(6) AND PLL161407/ (B)(6) DEVICES WERE REPORTED SEPARATELY. REPORTEDLY, SALMONELLA SPECIES WAS THE ISOLATED MICROORGANISM IN ALL HIS MICROBIOLOGIC SPECIMENS. ALL GORE DEVICES WERE EXPLANTED. NO NEW GORE DEVICES WERE IMPLANTED. THE PATIENT COMPLETED THE STUDY. 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

    ADDITIONAL INFORMATION: H6. CODE C19: A REVIEW OF THE STERILIZATION RECORDS OF THE DEVICE INDICATED THE LOT MET ALL THE PRE-RELEASE SPECIFICATIONS. H6. CODE C19: A REVIEW OF THE MANUFACTURING RECORDS OF THE DEVICE INDICATED THE LOT MET ALL THE PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS EXPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. PLEASE NOTE THAT GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC121000/ (B)(6) AND PLL161407/ (B)(6)) DEVICES WERE REPORTED SEPARATELY. REPORTEDLY, SALMONELLA SPECIES WAS THE ISOLATED MICROORGANISM IN ALL HIS MICROBIOLOGIC SPECIMENS. ALL GORE DEVICES WERE EXPLANTED. NO NEW GORE DEVICES WERE IMPLANTED. THE PATIENT COMPLETED THE STUDY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE ON OCTOBER 16, 2025, FROM THE IMEDIDATA STUDY DATABASE AND IMAGING EMAIL: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS DEVICE AND GORE®EXCLUDER®AAA ENDOPROSTHESIS DEVICES. THE GORE® DEVICES WERE SUCCESSFULLY IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS.THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED INFECTION RELATED TO GORE®EXCLUDER® DEVICES. REPORTEDLY, SALMONELLA SPECIES WAS THE ISOLATED MICROORGANISM IN ALL HIS MICROBIOLOGIC SPECIMENS. THE PATIENT HAD A MEDICATION TREATMENT USING CEFTRIAXONE 2G DAILY. ADDITIONALLY, THE PATIENT HAD IV BLOOD TEST AND A CTA. THE SCAN REVEALED THE INCREASING INFLAMMATORY CHANGES AROUND THE AORTIC STENTS. ALL THREE DEVICES WERE INFECTED. REPAIR WITH A SMALL ABSCESS COLLECTION FORMING WITHIN THIS. ON (B)(6) 2025, ALL DEVICES WERE EXPLANTED AND RIGHT AXILLARY BIFEMORAL GRAFT (OPEN SURGERY) WAS USED. NO NEW GORE DEVICES WERE IMPLANTED. THE PATIENT COMPLETED THE STUDY. THE PATIENT WAS DISCHARGED FROM THE CRITICAL CARE ON (B)(6) 2025 AND IS STABLE, RECOVERING ON IV ANTIBIOTICS. THE EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335349 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132634644

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other| R| H