BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 19432403 · Received May 30, 2024

    Report

    Report Number
    3007284313-2024-03274
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 20, 2024
    Report Date
    May 31, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. CODE D12: ACCORDING TO THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: IMPROPER COMPONENT PLACEMENT, OCCLUSION/STENOSIS OF DEVICE OR NATIVE VESSEL. 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) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE PATIENT¿S PROXIMAL AORTIC NECK CONDITION WAS POOR (BARREL-SHAPED). AFTER DEPLOYING THE PROXIMAL PART OF THE TRUNK-IPSILATERAL LEG COMPONENT, ANGIOGRAPHY CONFIRMED THAT IF THE IPSILATERAL LEG WAS DEPLOYED IN THIS POSITION, IT WOULD LAND IN THE EXTERNAL ILIAC ARTERY FOR 2 CM. SINCE IT WAS CONSIDERED DIFFICULT TO DEPLOY THE LEG WHILE PUSHING IT UP, IT WAS DEPLOYED AS IT WAS AND THE LEFT INTERNAL ILIAC ARTERY (IIA) WAS UNINTENTIONALLY COVERED. CONSIDERING THE PATENT RIGHT IIA AND THE PATIENT¿S ADVANCED AGE, THE UNINTENTIONAL COVERAGE OF THE IIA WAS LEFT FOR OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE TREATMENT AREA WAS SHORT, AND THE TRUNK-IPSILATERAL LEG WAS DEPLOYED AT MORE DISTAL SIDE THAN THE PLANNED LOCATION. THE AORTIC NECK CONDITION WAS POOR AND PUSHING THE DEVICE PROXIMALLY WAS ALSO CONSIDERED RISKY; THEREFORE, THE IPSILATERAL LEG WAS DEPLOYED AS IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299133 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other