BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 23176063 · Received September 29, 2025

    Report

    Report Number
    3013164176-2025-02691
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    April 2, 2025
    Report Date
    October 17, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED IN THE EVENT IF ANY; ADDITIONAL DEVICE(S) IMPLANTED INCLUDE: PLC181200/(B)(6) PLC271400/(B)(6), UDI: (B)(4). 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 INVESTIGATION DETERMINED NO PRODUCT PROBLEM OR DEFICIENCY CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT/INCIDENT FOR THE PATIENT; THE INITIAL MEDWATCH AND ANY SUPPLEMENTAL REPORT SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3013164176-2025-02691 WAS SUBMITTED IN ERROR AND IS HEREBY RETRACTED.

    Description of Event or Problem · 0

    ON (B)(6)2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2024 DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 68.5MM, WITH A MAXIMUM PROXIMAL LANDING ZONE DIAMETER OF 21MM. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD TECHNICAL SUCCESS AND WAS DISCHARGED TO (HOME- SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). REVIEW BY GORE IMAGING SERVICES (GIS) REPORTS DEVICE COMPRESSION/INFOLDING OF A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS DEVICE (PLC181400/(B)(6) OR PLC181200/(B)(6)) AND AN INDETERMINATE ENDOLEAK (CXT251412/(B)(6)) FROM AN UNKNOWN SOURCE. REVIEW OF THE CTA BY THE SITE REPORTS NO ENDOLEAK AND THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURES 62MM. THE SITE ADDITIONALLY REPORTS ALL DEVICES ARE REPORTED TO BE PATENT, WITH NO DEVICE INTEGRITY ISSUES. THERE ARE NO SCHEDULED PROCEDURES PLANNED FOR THE PATIENT AT THIS TIME; THE EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218748 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male