BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18726513 · Received February 16, 2024

    Report

    Report Number
    3013164176-2024-01984
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    February 1, 2024
    Report Date
    April 19, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. CODE B15 - IMAGES WERE PROVIDED, AND AN IMAGING EVALUATION WAS PERFORMED. AN ANALYSIS OF RELEVANT DATA WILL BE PERFORMED IN VIEW OF SUPPORTING THE IDENTIFICATION OF POSSIBLE CAUSES OF THE EVENT. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE ANEURYSM ENLARGEMENT AND ENDOPROSTHESIS OR DELIVERY SYSTEM: COMPONENT MIGRATION. THE IMAGING EVALUATION DETERMINED THE FOLLOWING: ONE SET OF CTA IMAGING WAS RECEIVED FOR EVALUATION. THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTIC ANEURYSM APPEARED TO BE 88.0MM X 94.8MM. THE IMAGES SHOWED THAT THE CONTRALATERAL LEG WAS IN THE AAA SAC. THERE WAS NO DEVICE APPOSITION IN THE LEFT COMMON ILIAC (LCI). THE LENGTH FROM THE DISTAL END OF THE CONTRALATERAL LEG IN THE AAA TO THE LCI OSTIUM APPEARED TO BE ~4.5CM, BY CENTERLINE. THE LENGTH OF THE LCI APPEARED TO BE ~8.5CM, BY CENTERLINE. THERE WAS SIGNIFICANT THROMBUS THROUGHOUT THE LCI. THE DIAMETERS RANGED FROM 17.8MM ¿ 63.4MM (PROXIMAL). THE PROXIMAL LEFT EXTERNAL ILIAC ARTERY DIAMETERS APPEAR TO RANGE FROM ~9.3MM ¿ 11.6MM. 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

    THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE, APPROXIMATELY FOUR YEARS AGO, THE PATIENT CAME IN WITH AN OCCLUDED AORTA AND ILIAC SYSTEM. THE PATIENT HAD A 9 TO 10 CENTIMETER ANEURYSM THAT THROMBOSED. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE TO TREAT THE ANEURYSM. THE LEFT INTERNAL ILIAC MUST HAVE BEEN OPENED SINCE A BIGGER BELL BOTTOM HAD TO BE USED. THE PATIENT HAD BAD ANATOMY AND NO FLOW IN HIS LEGS. THE SITUATION WAS EMERGENT. ON (B)(6) 2024, THE PATIENT RETURNED AND THE PHYSICIAN DISCOVERED THAT THE LEFT SIDED LIMB OF THE EXCLUDER WAS PULLED UP INTO THE ANEURYSM SACK (MIGRATION UNKNOWN). HE COULD NOT RECALL THE PATIENT'S PRIOR IMAGING AND COULD NOT REMEMBER IF THE LANDING ZONE OF THE COMMON ILIAC WAS GOOD. HIS INTENTION WAS ONLY TO TRY AND SAVE THE PATIENT AS THE QUALITY OF THE ARTERY WAS NOT GOOD AND LOST ITS SEAL. A REINTERVENTION OCCURRED. THE PHYSICIAN PLACED NEW LIMBS FROM THE EXISTING BELL BOTTOM INTO THE LEFT EXTERNAL ILIAC, AS THE LEFT INTERNAL ILIAC WAS THROMBOSED. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT. THE PHYSICIAN WAS ABLE TO GET A GOOD SEAL ON THE LEFT EXTERNAL ILIAC. THE CASE WENT SMOOTHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443584 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention