BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21363953 · Received February 12, 2025

    Report

    Report Number
    3007284313-2025-03758
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    February 6, 2025
    Report Date
    May 26, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618484
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED G3. H3: DEVICE EVALUATION COULD BE PERFORMED BECAUSE THE AFFECTED DEVICE CATHETER WAS RETURNED TO GORE. IMAGING RESULTS ARE AVAILABLE FOR THIS CATHETER BREAKING. H6: TYPE OF INVESTIGATION: CODE B01 ADDED. INVESTIGATION FINDING: C16 ADDED. C21 NO LONGER APPLICABLE. INVESTIGATION CONCLUSIONS: D0301 ADDED. D16 NO LONGER APPLICABLE. THE OLIVE AND CATHETER WAS INVESTIGATED WITH FOLLOWING RESULT: THE MANUFACTURING RECORDS WERE REVIEWED AND DOCUMENTED IN THE PRODUCT HISTORY TASK. THE DEVICE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PRODUCT INVESTIGATION REPORT - INVESTIGATION PERFORMED AND HAD THIS RESULT, THE REPORTED LEADING OLIVE SEPARATION WAS CONFIRMED DURING EVALUATION OF THE RETURNED DEVICE AND THROUGH EVALUATION OF THE PROVIDED PHOTOGRAPHS AND CLINICAL IMAGES. THE REPORTED INFORMATION INDICATES THE FORCE APPLIED TO THE DEVICE WAS NOT EXCESSIVE, AND THIS IS CONSISTENT WITH THE STATE OF THE RETURNED DEVICE AS OBSERVED DURING ENGINEERING EVALUATION: THE RETURNED DEVICE EXHIBITS NO EVIDENCE OF MATERIAL TRANSFER BETWEEN THE LEADING OLIVE AND THE GUIDEWIRE LUMEN TO INDICATE BOND CREATION BETWEEN THE TWO COMPONENTS. THE CAUSE FOR THE SEPARATED OLIVE IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY INVOLVING INSUFFICIENT BONDING.

    Additional Manufacturer Narrative · 0

    H6: CORRECTION FOR TYPE OF INVESTIGATION, CODE B15 WAS ENTERED INADVERTENTLY. THE B15 IS NOT APPLICABLE AND IS REMOVED.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H3: DEVICE IS NOT YET RETURNED TO GORE. A PRODUCT HISTORY REVIEW WAS COMPLETED AND REVIEW OF MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6, B15: IMAGES HAVE BEEN PROVIDED AND ARE CURRENTLY BEING REVIEWED. 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

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE TO TREAT WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351416) AN ABDOMINAL ANEURYSM REPAIR [AAA]. THE PHYSICIAN NOTICED THAT AFTER RELEASING THE ENDOPROSTHESIS, THE OLIVE (LEADING TIP) DETACHED FROM THE CATHETER. THEN, HE USED A GOOSENECK CATHETER TO CATCH IT AND TAKE IT OUT OF THE GORE ® DRYSEAL FLEX INTRODUCER SHEATH. THE EVAR PROCEDURE WAS COMPLETED AND THE STENT GRAFT REMAINS SUCCESSFULLY IMPLANTED. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895746 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown