BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 24899318 · Received April 16, 2026

    Report

    Report Number
    3007284313-2026-04710
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 16, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622450
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6, THE INVESTIGATION IS ONGOING. PRELIMINARY RESULTS ARE NOT YET AVAILABLE. COMMUNICATION WITH THE SITE WAS COMPLETED. THE DEVICES WERE EXPLANTED AND DISCARDED AT THE SITE, THEREFORE, NO PRODUCT EVALUATION COULD BE PERFORMED. D10: CONCOMITANT MEDICAL DEVICES, THE DIRECTLY INVOLVED DEVICES IN THIS EVENT WERE EXPLANTED (THREE GORE DEVICES IN TOTAL), THESE TWO PLCS WERE REPORTED (WITH SAME 'P020004' PMA/510(K) NUMBER AS THE RLT DEVICE): GORE® EXCLUDER® AAA ENDOPROSTHESIS, CONTRALATERAL LEG DEVICE (2XPLC, SN: (B)(6)). 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) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC ANEURYSM REPAIR TO TREAT THE ABDOMINAL AORTA WITH FOLLOWING DEVICES: GORE® EXCLUDER® AAA ENDOPROSTHESIS, TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT, SN: (B)(6)), GORE® EXCLUDER® AAA ENDOPROSTHESIS, CONTRALATERAL LEG ENDOPROSTHESIS (2XPLC, SN: (B)(6)), GORE® EXCLUDER® AAA ENDOPROSTHESIS, ILIAC EXTENDER ENDOPROSTHESIS (PLL, SN: (B)(6)), AND GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE - VBX (PAHR101002E, SN: (B)(6)). THE PLL ILIAC EXTENDER AND THE VBX DEVICE HAS BEEN IMPLANTED FURTHER DISTALLY, IN THE ILIAC ARTERY (UNKNOWN IN WHICH SIDE THEY HAVE BEEN IMPLANTED). ALSO, THE GORE® ACCESSORIES (2X DSF, DSF1833 & DSF1233) WERE USED FOR THE PROCEDURE. THERE WERE NO COMPLICATIONS DURING THE IMPLANT PROCEDURE. ON (B)(6) 2026, THE GORE FIELD ASSOCIATE WAS NOTIFIED THAT AN ENDOLEAK TYPE II ORIGINATING FROM LUMBAR ARTERIES RESULTED IN AN ANEURYSM SAC ENLARGEMENT OF AT LEAST 1 CM. THERE IS NO CTA DATA AVAILABLE AND THE ONSET DATE OF THE ENDOLEAK TYPE II REMAINS UNKNOWN. AS THE PHYSICIAN STATED, EMBOLIZATION WAS NOT FEASIBLE; THEREFORE, THE STENT GRAFTS WERE SURGICALLY EXPLANTED ON THAT DAY. ALSO, IT WAS CONFIRMED TO THE FIELD SALES ASSOCIATE THAT THERE WERE NO DEFECTS OR ABNORMALITIES IDENTIFIED WITH THE STENT GRAFTS. THE EXPLANTED GORE DEVICES WERE REPORTED AS THE RLT (SN: (B)(6)) AND THE TWO PLC DEVICES (SN: (B)(6)). AFTER THE EXPLANT, THE SURGEON TOLD THAT THE PLL DEVICE AND THE VBX DEVICE WERE LEFT IN SITU BECAUSE THEY COULD NOT BE SAFELY REMOVED, WITH NO IMPACT REPORTED. THE AORTIC REPAIR WAS THEN COMPLETED DURING THE SAME INTERVENTION, THE THREE EXPLANTED GORE DEVICES WERE REPLACED BY AN OPEN SURGICAL GRAFT, THE BRAND NAME OF THE NEW IMPLANTED DEVICE IS UNKNOWN. THE EXPLANTED GORE DEVICES WERE DISPOSED BY THE SITE ALREADY. THE PATIENT TOLERATED THE EXPLANT PROCEDURE AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959380 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H10/H11.