BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20504681 · Received October 22, 2024

    Report

    Report Number
    3007284313-2024-03528
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    October 1, 2024
    Report Date
    May 15, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622535
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. AS PART OF OUR ROUTINE QUALITY PROCEDURES, EACH BATCH OF DEVICES UNDERGOES COMPREHENSIVE QUALITY CONTROL TESTING AND INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. GORE REVIEWED THE MANUFACTURING RECORDS ASSOCIATED WITH THE REPORTED LOT NUMBER AND VERIFIED THAT ALL RELEASE CRITERIA HAD BEEN MET. ENGINEERING EVALUATION OF THE DELIVERY SYSTEM IS PLANNED (CURRENTLY IN TRANSIT). 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

    CORRECTED H3: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A VIDEO WAS INSTEAD SUPPLIED BY THE INITIAL REPORTER. CORRECTED H6: ADDED TYPE OF INVESTIGATION CODE B15. UPDATED INVESTIGATION FINDINGS CODE TO C24, CODE C21 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D15, CODE D16 IS NO LONGER APPLICABLE. THE REPORTED FAILURE MODE THAT THE OLIVE TIP DISCONNECTED FROM THE CATHETER WAS CONFIRMED THROUGH AN EVALUATION OF THE PROVIDED VIDEO. THE VIDEO SHOWED THE POLYIMIDE GUIDEWIRE LUMEN SEPARATE FROM THE REST OF THE DELIVERY CATHETER. THE TRAILING END OF THE POLYIMIDE GUIDEWIRE LUMEN APPEARED TO HAVE A CLEAN CUT, BUT THE VIDEO QUALITY IS POOR, AND THE REST OF THE DELIVERY CATHETER IS NOT VISIBLE IN THE VIDEO TO EVALUATE; THEREFORE, IT IS UNKNOWN IF THERE WAS AN INSUFFICIENT BOND. IN ADDITION, THERE IS NO INFORMATION ON THE FORCE REQUIRED TO WITHDRAW THE CATHETER. THE ROOT CAUSE FOR THE SEPARATED POLYIMIDE GUIDEWIRE LUMEN CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    UPDATED D9, G3. CORRECTED H6: ADDED TYPE OF INVESTIGATION CODE B01. UPDATED INVESTIGATION FINDINGS CODE TO C16, CODE C24 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D0301, CODE D15 IS NO LONGER APPLICABLE. UPDATED INFORMATION BASED ON DEVICE EVALUATION: THE REPORTED FAILURE MODE THAT THE OLIVE TIP DISCONNECTED FROM THE CATHETER WAS CONFIRMED THROUGH AN EVALUATION OF THE PROVIDED VIDEO AND RETURNED DELIVERY CATHETER. THE VIDEO SHOWED THE POLYIMIDE GUIDEWIRE LUMEN SEPARATE FROM THE REST OF THE DELIVERY CATHETER, WITH THE TRAILING END APPEARING TO HAVE A CLEAN CUT. IN ADDITION, NO BONDING RESIDUE WAS OBSERVED ON THE TRAILING END OF THE RETURNED POLYIMIDE GUIDEWIRE LUMEN. THEREFORE, THE CAUSE FOR THE SEPARATED POLYIMIDE GUIDEWIRE LUMEN IS AN INSUFFICIENT GUIDEWIRE LUMEN BOND.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281414) WAS IMPLANTED IN A PATIENT FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). AFTER A SUCCESSFUL DEVICE DEPLOYMENT, UPON REMOVAL OF THE DELIVERY SYSTEM, IT WAS DISCOVERED THAT THE OLIVE TIP BECAME DISCONNECTED FROM THE CATHETER AND COULD SLIDE FREELY ON THE LUNDERQUIST® EXTRA-STIFF WIRE GUIDE. THE PATIENT IS DOING WELL AND WAS NOT AFFECTED BY THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946760 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other