BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21973503 · Received May 6, 2025

    Report

    Report Number
    3013164176-2025-02506
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 28, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618651
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FIRST REPORTED DEVICE FAILURE MODE, A KINK IN THE ENDOPROSTHESIS AFTER DEPLOYMENT, COULD NOT BE INDEPENDENTLY CONFIRMED THROUGH EVALUATION OF THE PROVIDED IMAGES. THE REPORTED INFORMATION INDICATES THE PATIENT¿S COMMON ILIAC ARTERIES WERE TORTUOUS, AND THE CAUSE FOR THE KINK IN THE DEVICE MAY BE ATTRIBUTED TO THE PATIENT CONDITION. THE SECOND REPORTED DEVICE FAILURE MODE, SEPARATION OF THE DISTAL END OF THE DELIVERY SYSTEM, WAS CONFIRMED THROUGH EVALUATION OF THE PROVIDED CLINICAL IMAGES AND PHOTOGRAPHS. THE LEADING OLIVE WAS OBSERVED IN THE CLINICAL IMAGES WITH A NON-GORE DEVICE, BUT THE DELIVERY CATHETER COULD NOT BE VISUALIZED IN THE CLINICAL IMAGES. THE PHOTOGRAPH OF THE BROKEN DELIVERY SYSTEM CONFIRMS THE LEADING END OF THE DELIVERY CATHETER BROKE AT THE TRAILING OLIVE. THE REPORTED INFORMATION INDICATES THE DELIVERY SYSTEM BROKE DURING WITHDRAWAL THROUGH THE DEPLOYED ENDOPROSTHESIS WHICH WAS ALREADY KINKED AND MAY HAVE INTERACTED WITH THE DELIVERY SYSTEM AS IT WAS WITHDRAWN. THE DEVICE INSTRUCTIONS FOR USE WARN AGAINST CONTINUING TO WITHDRAW THE DEVICE WHEN RESISTANCE IS ENCOUNTERED; HOWEVER, THERE WAS NO REPORTED INDICATION OF RESISTANCE DURING WITHDRAWAL, AND A CAUSAL RELATIONSHIP BETWEEN THE DELIVERY SYSTEM SEPARATION AND WITHDRAWAL OF THE DEVICE THROUGH A KINKED ENDOPROTHESIS COULD BE NEITHER CONFIRMED NOR DISMISSED. THE SPECIFIC CAUSE FOR THE SEPARATION OF THE LEADING END OF THE DELIVERY SYSTEM COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THIS PATIENT UNDERWENT REINTERVENTION OF A PREVIOUSLY IMPLANTED ENDOLOGIX DEVICE. THE PATIENT UNDERWENT EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY (LIIA) AND A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT WAS THEN IMPLANTED TO EXTEND COVERAGE DOWN TO THE LEFT EXTERNAL ILIAC ARTERY WITH INTENTIONAL COVERAGE OF THE LIIA WITH ADEQUATE OVERLAP WITHIN THE EXISTING DEVICE. IT WAS REPORTED THAT THE PATIENT¿S COMMON ILIAC ARTERIES (CIIA) WERE QUITE TORTUOUS AND IT WAS REPORTED THAT POST DEPLOYMENT OF THE EXTENSION DEVICE THE GORE CONTRALATERAL LIMB CONFORMED TO THE TORTUOUS VESSEL AND CAUSED A KINK, CAUSING DECREASED BLOOD FLOW. WHEN REMOVING THE DEVICE DELIVERY CATHETER THE NOSE CONE (LEADING OLIVE) FRACTURED AND DETACHED FROM THE DELIVERY CATHETER. THE PHYSICIAN WAS CONCERNED ABOUT THE KINK AND BLOOD FLOW, SO HE PERFORMED ANGIOPLASTY OF THE KINKED AREA. NEXT THE PHYSICIAN PERFORMED AN ANGIOGRAM WHICH SHOWED THE KINK HAD RESOLVED. IT WAS NOTED THAT WITH THE BALLOON INSERTION THE NOSE CONE HAD MOVED SLIGHTLY PROXIMAL CLOSER TO THE DISTAL WAIST OF THE AORTA. AT THIS TIME WIRE ACCESS WAS LOST AT THE LEVEL OF THE DISTAL WAIST (THIS IS WHERE THE SECOND COMPONENT OF THE ENDOLOGIX GRAFT WAS). THE WIRE WAS ADVANCED BUT COULD NOT BE CONFIRMED AS TRUE LUMEN (NOT WITHIN THE ENDOLOGIX STRUTS) BECAUSE OF THE NOSE CONE BEING ON THE DISTAL END OF THE WIRE STILL. AS THE WIRE WAS BEING ADVANCED, THE NOSE CONE TRAVELED TO THE PROXIMAL PORTION OF THE ENDOLOGIX GRAFT. (PICTURES ARE ATTACHED) THE PHYSICIAN FELT THAT THE NOSE CONE WAS TRAPPED BETWEEN THE ENDOLOGIX FABRIC AND THE BARE METAL CAGE. A CT SCAN WAS PREFORMED TO CONFIRM. THE PHYSICIAN OPTED TO END THE PROCEDURE AND FOLLOW PATIENT CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443859 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618651

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male