BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21224755 · Received January 23, 2025

    Report

    Report Number
    3013164176-2025-02363
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    December 13, 2024
    Report Date
    March 13, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618712
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.5. OPERATOR OF DEVICE: THE "OTHER" OPTION WAS SELECTED BECAUSE THE "HEALTH CARE PROFESSIONAL" OPTION WAS GIVING AN ERROR IN THE SOFTWARE USED TO SUBMIT REPORTS. H.6. INVESTIGATION FINDINGS CODE C21: CONCLUSIONS WAITING ON RESULTS OF PRODUCT EVALUATION. 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

    H.6. INVESTIGATION FINDINGS CODE C19: THE MANUFACTURING RECORDS WERE REVIEWED AND DOCUMENTED IN THE PRODUCT HISTORY TASK. THE DEVICE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION FINDINGS CODE C20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. H.6. INVESTIGATION FINDINGS CODE C070601: THE REPORTED DEVICE FAILURE MODE, COMPRESSION OF THE DEVICE OBSERVED DURING FOLLOW-UP IMAGING TWO TO THREE WEEKS AFTER IMPLANT, WAS CONFIRMED THROUGH EVALUATION OF THE PROVIDED CLINICAL IMAGES FOR THE CONTRALATERAL LEG DEVICE.THE COMPRESSION WAS REPORTED TO HAVE OCCURRED IN A NARROWED REGION OF THE AORTA, AND THE PHYSICIAN DID NOT USE THE ¿KISSING BALLOON TECHNIQUE¿ IN THIS REGION, BUT THE SPECIFIC CAUSE FOR THE COMPRESSION OF THE CONTRALATERAL LEG DEVICE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. H.6. INVESTIGATION CONCLUSIONS CODE D15: THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, A FOLLOW-UP CT SCAN WAS TAKEN. ON (B)(6) 2024, THE PHYSICIAN NOTIFIED THE FSA THAT THERE WAS COMPRESSION OF THE CONTRALATERAL LIMB ON THE CT SCAN. BASED ON THE CT SCANS FROM THE ORIGINAL PROCEDURE, THE COMPRESSION APPEARS TO BE LOCATED WHERE THE AORTA NARROWS. ON (B)(6) 2024, THE PHYSICIAN IS REINTERVENED BY IMPLANTING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) INTO THE PROXIMAL PORTION OF THE EXCLUDER AND BALLOONING. THE PATIENT TOLERATED THE PROCEDURE. ACCORDING TO THE FSA WHO COVERED THE INITIAL PROCEDURE, THE PHYSICIAN DID NOT USE THE KISSING BALLOON TECHNIQUE WHEN BALLOONING IN THE NARROW PART OF THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662668 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618712

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention