BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 21397438 · Received February 18, 2025

    Report

    Report Number
    3013164176-2025-02391
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    November 28, 2024
    Report Date
    February 18, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132635313
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D12: IFU STATEMENTS THE INTERNAL ILIAC COMPONENT DEVICE IFU WAS REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL FOR THE APPLICABLE REGION AND TIME PERIOD. THE FOLLOWING STATEMENTS WERE IDENTIFIED IN RELATION TO THE COMPLAINT. [DEFECTS AND ADVERSE EVENTS] POSSIBLE DEFECTS AND ADVERSE EVENTS INCLUDE THE FOLLOWING: ¿ ARTERIAL OR VENOUS THOMBOSIS AND/OR PSEUDOANEURYSM ¿ OCCLUSION 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

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND THE RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. FIVE COMPONENTS WERE DEPLOYED: 1X TRUNK IPSILATERAL LEG, 2X CONTRALATERAL LEGS, 1X ILIAC BRANCH COMPONENT (IBC), AND 1X INTERNAL ILIAC COMPONENT (IIC). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A CT SCAN REVEALED A TYPE I ENDOLEAK AT THE DISTAL END OF THE CONTRALATERAL LEG, WHICH HAD BEEN PLACED IN THE RIGHT COMMON ILIAC ARTERY. ADDITIONALLY, A THROMBUS WAS OBSERVED INSIDE BOTH THE IBC AND THE IIC. HOWEVER, NO INTERVENTION WAS PERFORMED AND THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. ON (B)(6) 2024, A CT SCAN REVEALED A THROMBOTIC OCCLUSION OF THE LEFT INTERNAL ILIAC ARTERY WHERE THE IIC HAD BEEN DEPLOYED. HOWEVER, RETROGRADE BLOOD FLOW WAS OBSERVED IN THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES. THROMBUS WAS STILL PRESENT IN THE IBC, BUT NO OCCLUSION WAS OBSERVED. THE PHYSICIAN¿S COMMENT: ¿I SHOULD HAVE CONSIDERED MEDICATION WHEN A THROMBUS WAS FIRST OBSERVED IN THE LEFT INTERNAL ILIAC ARTERY. UPON REVIEWING THE CT IMAGES, SLIGHT STENOSIS WAS NOTED IN THE LEFT INTERNAL ILIAC ARTERY. I SHOULD HAVE EXPANDED IT BY BALLOON DURING THE PROCEDURE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157791 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132635313

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Other