BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 23385877 · Received October 24, 2025

    Report

    Report Number
    3007284313-2025-04336
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 19, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651054
    PMA / PMN Number
    P200030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION PERFORMED BY ENGINEERING SHOWED THE FOLLOWING: AS RETURNED, THE LOOP GUIDE TUBE (A COMPONENT OF THE DEVICE HANDLE) WAS DAMAGED AND HAD BEEN DETACHED FROM ITS INTENDED LOCATION. THE LOOP GUIDE TUBE WAS RETURNED ON THE CONSTRAINING LOOP COMPONENT, WHICH WAS ALSO DAMAGED. THERE WAS ALSO DAMAGE TO OTHER INTERNAL COMPONENTS OF THE HANDLE, THE SPINE ADAPTOR AND RING ASSEMBLY HAD BECOME DETACHED FROM THE SPINE. THE STATE OF THE RETUNED DEVICE IS CONSISTENT WITH A FORCEFUL ROTATION OF THE TRANSPARENT KNOB. THIS IS CONSISTENT WITH THE REPORTED EVENT ¿THE PHYSICIAN SLID THE RED SAFETY LOCK BACK AND ROTATED THE TRANSPARENT KNOB AND ENCOUNTERED RESISTANCE DURING DEPLOYMENT. IT IS BELIEVED THE TRANSPARENT KNOB WAS TURNED THE WRONG WAY LEADING TO DEPLOYMENT RESISTANCE¿. NO MANUFACTURING DEFICIENCY WAS IDENTIFIED, THEREFORE, PER ENGINEERING EVALUATION TASK PROCEDURE A CAPA REQUEST WAS NOT GENERATED, AND THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED THROUGH THE PROCEDURE FOR EVENT TRENDING, ANALYSIS, AND REVIEW.

    Additional Manufacturer Narrative · 0

    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, THIS PATIENT UNDERWENT REINTERVENTION TO TREAT AN ENDOLEAK FROM A PREVIOUS ENDOVASCULAR TREATMENT WITH ENDOLOGIX DEVICES (DATE UNKNOWN). DURING THE PROCEDURE IT WAS REPORTED THAT DURING DEPLOYMENT OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, DURING REMOVAL OF THE CONSTRAINING MECHANISM AND DEPLOYMENT OF THE SECONDARY SLEEVE, THE PHYSICIAN SLID THE RED SAFETY LOCK BACK AND ROTATED THE TRANSPARENT KNOB AND ENCOUNTERED RESISTANCE DURING DEPLOYMENT. IT IS BELIEVED THE TRANSPARENT KNOB WAS TURNED THE WRONG WAY LEADING TO DEPLOYMENT RESISTANCE AND THE LOCK PIN DISENGAGING. THE DEVICE WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT AND AS INTENDED. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594640 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132651054

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male