BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 24385869 · Received February 19, 2026

    Report

    Report Number
    3013164176-2026-02909
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 19, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132635313
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A LEFT INTERNAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. AFTER DEPLOYING THE ILIAC BRANCH COMPONENT(IBC) IN RIGHT ILIAC ARTERY, THE INTERNAL ILIAC COMPONENT(IIC) WAS ADVANCED USING U-TURN TECHNIQUE. DURING ADVANCING THE IIC DEVICE, THE DSF SHEATH BECAME DISLODGED FROM THE RIGHT INTERNAL ILIAC GATE. THE DELIVERY OF THE IIC DEVICE WAS CONTINUED, BUT IT WAS DIFFICULT, AND X-RAY IMAGING CONFIRMED THAT THE ROOT OF THE OLIVE TIP HAD BENT 180 DEGREES. ATTEMPTS WERE MADE TO WITHDRAW THE DEVICE; HOWEVER, THE REMOVAL WAS DIFFICULT. DURING REPEATED PUSH-AND-PULL MANIPULATION OF THE DELIVERY CATHETER, THE STENT GRAFT INITIATED TO DEPLOY WITHIN THE IPSILATERAL LEG OF IBC DEVICE AND SUBSEQUENTLY FULLY DEPLOYED. UPON WITHDRAWING THE DELIVERY CATHETER, IT WAS CONFIRMED THAT THE DISTAL PART OF THE DELIVERY CATHETER WAS SEPARATED. AN ATTEMPT WAS MADE TO RETRIEVE IT FROM THE IPSILATERAL SIDE USING A SNARE CATHETER BUT WAS UNSUCCESSFUL, SO THE CONTRALATERAL SIDE WAS PUNCTURED, AND THE SEPARATED DISTAL PART WAS SUCCESSFULLY RETRIEVED WITH A SNARE CATHETER. THE PROCEDURE THEN CONTINUED USING UP AND OVER TECHNIQUE AND WAS COMPLETED UNEVENTFULLY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT IT WAS RECOGNIZED THAT THE DSF SHEATH HAD COME OUT OF THE INTERNAL ILIAC GATE DURING ADVANCING THE IIC DEVICE USING U-TURN TECHNIQUE, BUT THE IIC DEVICE WAS STILL CONSIDERED DELIVERABLE. IT WAS ALSO REPORTED THAT THE CATHETER MIGHT HAVE BEEN PUSHED TOO FORCEFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56129 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132635313

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male