BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22070149 · Received May 22, 2025

    Report

    Report Number
    3013164176-2025-02529
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    April 28, 2025
    Report Date
    May 22, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618668
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS CODE C20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. H.6. INVESTIGATION FINDINGS CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION CONCLUSIONS CODE D1102: THE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL FOR THE APPLICABLE REGION AND TIME PERIOD, AND THE FOLLOWING IFU STATEMENTS WERE IDENTIFIED IN RELATION TO SIZE SELECTION AND THE REPORTED DEPLOYMENT TECHNIQUE OF PUSHING THE DEVICE UP DURING DEPLOYMENT. ARTERIAL ACCESS AND ANGIOGRAPHY: 1. FOLLOWING STANDARD PRACTICES, ACCESS THE INTENDED CONTRALATERAL SIDE VIA A PERCUTANEOUS DIAGNOSTIC SHEATH, AND PERFORM MARKER CATHETER DIGITAL SUBTRACTION ANGIOGRAPHY (AP, OBLIQUE, AND LATERAL VIEWS AS NECESSARY) TO CONFIRM THE CORRECT DEVICE COMPONENT SIZING, AND DEPLOYMENT LOCATIONS. CONSIDER BREATH-HOLD TECHNIQUE TO OPTIMIZE IMAGE QUALITY. LEAVE MARKER CATHETER IN PLACE AT THE LEVEL OF THE RENAL ARTERIES. CONTRALATERAL LEG ENDOPROSTHESIS POSITIONING AND DEPLOYMENT: 1. ADVANCE THE PREPPED CONTRALATERAL LEG ENDOPROSTHESIS DELIVERY CATHETER TO THE LEVEL OF THE LONG RADIOPAQUE MARKER. 2. ALIGN THE RADIOPAQUE MARKER AT THE PROXIMAL END OF THE CONTRALATERAL LEG ENDOPROSTHESIS WITH THE LONG CONTRALATERAL RADIOPAQUE MARKER ON THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. WITH THE ALIGNMENT OF THESE MARKERS, AN APPROXIMATE 3 CM OVERLAP WILL BE ACHIEVED. 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) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (EXCC) WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEGS. FOLLOWING DEPLOYMENT OF THE PLC161000 EXTENSION TO THE IPSILATERAL LIMB IN THE RIGHT COMMON ILIAC, IT WAS NOTICED THAT THE DEVICE WAS UNINTENTIONALLY COVERING THE RIGHT INTERNAL ILIAC ARTERY. THE ARTERY WAS RETROFILLING FROM THE LEFT INTERNAL ILIAC, SO THE PHYSICIAN DECIDED NO TREATMENT WAS NEEDED FOR THAT TIME. REPORTEDLY, THE DISTAL RADIOPAQUE MARKER WAS MISIDENTIFIED ON THE ANGIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971926 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618668

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other