BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21606687 · Received March 14, 2025

    Report

    Report Number
    3007284313-2025-03826
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 14, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622443
    PMA / PMN Number
    P020004
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION FINDINGS CODE C20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. H6: INVESTIGATION FINDINGS CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. AS IT IS UNKNOWN WHICH DEVICE IS DISTAL TO THE DILATATION, ADDITIONAL GORE® EXCLUDER® DEVICES ARE CAPTURED ON THIS REPORT: #1: SN: (B)(6); UDI: (B)(4); CATALOG: PLC271000. #2: SN: (B)(6); UDI: (B)(4); CATALOG: PLC181000. 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

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM. ON (B)(6) 2025, IT WAS DISCOVERED THAT THE RIGHT COMMON ILIAC OF THE PATIENT HAD DILATED. ON (B)(6) 2025, THE PHYSICIAN REINTERVENED EXTENDING WITH A CONTRALATERAL LEG DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228105 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622443

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male