BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 22547135 · Received July 18, 2025

    Report

    Report Number
    3013164176-2025-02609
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 16, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618743
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT MEDICATIONS: LISINOPRIL 40MG QD, NIFEDIPINE 60MG QD, HCTZ TRIAMTORINE 25/37.5 QD, METOPROLOL 50MG BID, ATORVASTATIN 80MG HS, ASPIRIN 81MG QD. 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 HAVE NOT 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

    CORRECTION TO H1.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. SEVERAL GORE® DRYSEAL FLEX INTRODUCER SHEATHS WERE USED DURING THE PROCEDURE. IT WAS REPORTED THAT THE FOLLOWING EVENTS HAPPENED DURING THE PROCEDURE. ¿ A SECOND PLC181000/(B)(6) COULD NOT TRAVERSE; SHEATH AND WIRE AGAIN DEMONSTRATED INSTABILITY AND KINKED AT SITE WITH TORTUOSITY. ADVANTAGE WIRE USED TO RE-ESTABLISH ACCESS. ¿ DESPITE REPOSITIONING, DEVICE COULD NOT BE APPROPRIATELY PLACED; ATTEMPTED WITHDRAWAL RESULTED IN PREMATURE DEPLOYMENT (PLC) OF THE GRAFT IN RIGHT COMMON ILIAC ARTERY (RCIA) EXTENDING INTO RIGHT EXTERNAL ILIAC ARTERY (REIA), UNINTENTIONALLY COVERING THE RIGHT INTERNAL ILIAC ARTERY (RIIA). ¿ PREMATURE RIGHT LIMB DEPLOYMENT LEFT A GAP BETWEEN GATE AND LIMB. PLC201000 (SN (B)(6)) DEPLOYED VIA RIGHT 12FR SHEATH TO BRIDGE THE LIMB GAP, SUCCESSFUL DEPLOYMENT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400551 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618743

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization