BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 22440308 · Received July 8, 2025

    Report

    Report Number
    3007284313-2025-04091
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 8, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132634279
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. IMAGING EVALUATION SUMMARY: THE IMAGES RECEIVED CANNOT BE USED TO PERFORM A FULL IMAGING EVALUATION BECAUSE THEY DO NOT MEET THE DICOM STANDARD. THE EXTENT AND ACCURACY OF THE OBSERVATIONS AND FINDINGS MAY BE LIMITED DUE TO THE COMPLETENESS, FORMAT AND/OR QUALITY OF THE IMAGES PROVIDED FOR REVIEW. GORE CANNOT GUARANTEE THE IMAGES PROVIDED ARE COMPLETE, ACCURATE OR LACK ALTERATION. THEREFORE, GORE CANNOT GUARANTEE ALL KEY FINDINGS HAVE BEEN CAPTURED OR THAT THE FINDINGS ARE ACCURATE. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: PDF IMAGING SHOWS PRE-PROCEDURAL PLANNING. ABDOMINAL AORTA APPEARS TORTUOUS/ANGULATED WITH A LATERAL ANGLE OF 115 DEGREES. CANNOT CONFIRM A TYPE 1A ENDOLEAK WITH THE IMAGING PROVIDED. CANNOT CONFIRM PLACEMENT OF AORTIC EXTENDER THAT COVERED THE RIGHT RENAL ARTERY. 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 HAVE NOT 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, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL AND AORTIC EXTENDER). REPORTEDLY, AN AORTIC EXTENDER CONFORMABLE WAS DEPLOYED TO TREAT A TYPE 1A ENDOLEAK AT COMPLETION RUN ON THE TRUNK IPSILATERAL LEG, HOWEVER, IN DOING SO, THE RIGHT RENAL ARTERY WAS COVERED CAUSING SLIGHT RENAL MALPERFUSION. PHYSICIAN STATED IT WAS A CLINICAL JUDGEMENT IN SACRIFICING THE RIGHT RENAL ARTERY TO OBTAIN SEAL RESOLVING THE TYPE 1A ENDOLEAK, ATTEMPT WAS TO RESOLVE IT WITHOUT COVERING BUT PHYSICIAN WAS AWARE IT MIGHT NEED TO BE COVERED. THERE WAS SLIGHT MALPERFUSION WHICH WILL BE MEDICALLY MANAGED WHERE NECESSARY. PATIENT TOLERATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843445 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132634279

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other| R