BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21319500 · Received February 6, 2025

    Report

    Report Number
    3007284313-2025-03748
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 7, 2025
    Report Date
    April 3, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. TYPE OF INVESTIGATION: CODE B20 ADDED. H.6. INVESTIGATION FINDINGS FOR DEVICE NOT ACCESSIBLE FOR TESTING: CODE C20 ADDED. H.6. INVESTIGATION FINDINGS FOR COMMUNICATION/INTERVIEWS: CODE C21 UPDATED TO CODE C20. H.6. INVESTIGATION CONCLUSIONS: CODE D16 UPDATED TO CODE D15. 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.

    Additional Manufacturer Narrative · 0

    A.4. PATIENT WEIGHT: ASKED BUT UNAVAILABLE. B.7. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: ASKED BUT UNAVAILABLE. D.4. DEVICE INFORMATION: THE DEVICE LOT/SERIAL NUMBER WAS REQUESTED BUT WAS UNAVAILABLE. THEREFORE, DEVICE INFORMATION REMAINS UNKNOWN. D.6A. IF IMPLANTED, GIVE DATE: DATE OF DEVICE IMPLANT WAS REQUESTED, BUT IS UNAVAILABLE. D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE. H.4. DEVICE MANUFACTURE DATE: AS THE DEVICE LOT/SERIAL NUMBER IS UNAVAILABLE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. H.6. TYPE OF INVESTIGATION: CODE B22 - ATTEMPTS WERE MADE TO OBTAIN THE DEVICE LOT/SERIAL NUMBER, AND THE LOT/SERIAL NUMBER WAS UNAVAILABLE. NO DEVICE HISTORY RECORD REVIEW WAS ABLE TO BE COMPLETED. 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

    ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION OF A PREVIOUS ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM TREATMENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT) ON AN UNKNOWN DATE. IT WAS REPORTED THAT A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT WAS USED TO RELINE THE ORIGINAL RLT. AN AORTO-UNI-ILIAC PROCEDURE WAS ALSO PERFORMED. THERE WAS NO FURTHER INFORMATION AVAILABLE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531665 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention