BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21694882 · Received March 26, 2025

    Report

    Report Number
    3007284313-2025-03852
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 26, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    04993024009844
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: IMPROPER COMPONENT PLACEMENT, OCCLUSION OF DEVICE OR NATIVE VESSEL. 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 INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE TREATMENT, A TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED USING A SOFT AREA OF A EGOIST FLEX GUIDEWIRE, THE PROXIMAL EDGE OF THE TRUNK AT THE OUTER CURVATURE (LEFT SIDE) POSITIONED DISTALLY AS TARGETED. THE CONSTRAINING SYSTEM WAS USED HOWEVER THE LOCATION OF THE PROXIMAL EDGE WAS UNCHANGED. AFTER CANNULATION OF THE CONTRALATERAL SIDE, THE CLEAR KNOB WAS REMOVED. THE PROXIMAL SIDE WAS BALLOONED AND THE IPSILATERAL LEG WAS PUSHED UP. AN ANGIOGRAPHY REVEALED THAT THE TRUNK SLIGHTLY COVERED THE RIGHT RENAL ARTERY. BLOOD FLOW INTO THE RIGHT RENAL ARTERY WAS NO ISSUE. FOR THE RIGHT RENAL ARTERY, AN EXPRESS SD 6 X 18 WAS IMPLANTED INTO THE RIGHT RENAL ARTERY AFTER PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY JUST FOR SAFE. AN ANGIOGRAPHY REVEALED THAT BLOOD FLOW INTO THE RIGHT RENAL ARTERY WAS NO ISSUE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT REGARDING THE COVERAGE OF THE RIGHT RENAL ARTERY, HE DID NOT THINK THE ARTERY WAS COVERED WHEN THE TRUNK WAS DEPLOYED. IT WAS UNCLEAR IF IT WAS MOVED WHEN THE IPSILATERAL LEG WAS PUSHED UP. IT WOULD HAVE BEEN BETTER TO PERFORM AN ANGIOGRAPHY AND CHECKED THE DEPLOYMENT POSITION OF THE TRUNK BEFORE REMOVING THE CLEAR KNOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093145 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 04993024009844

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention