BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 7306952 · Received March 1, 2018

    Report

    Report Number
    2953161-2018-00022
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    December 22, 2010
    Report Date
    February 20, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN WHICH OF THE THREE IMPLANTED DEVICES WERE INVOLVED IN THE REPORTED TYPE II ENDOLEAK. THE DEVICES INFORMATION OF THE TWO ADDITIONAL DEVICES ARE: PXC141200/06834335 (B)(4) AND PXL161407/06693713 (B)(4). ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK, ANEURYSM ENLARGEMENT AND SURGICAL CONVERSION. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO REPAIR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. FINAL ANGIOGRAPHY SHOWED A TYPE II ENDOLEAK, AND THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK. THE PROCEDURE WAS CONCLUDED, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2014, A REINTERVENTION WAS PERFORMED, AND THE LUMBER ARTERY WAS COIL EMBOLIZED TO REPAIR THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. HOWEVER, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SEEMED THAT THE ANEURYSM WAS STILL ENLARGED (AMOUNT UNKNOWN) AFTER THE REINTERVENTION. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2018, IT WAS CONFIRMED THAT THE ANEURYSM WAS RAPIDLY ENLARGED (AMOUNT UNKNOWN). AN OPEN SURGERY WAS PERFORMED, AND IT WAS CONFIRMED THERE WAS NO ENDOLEAK. IT WAS CONSIDERED THAT THE ANEURYSM ENLARGED DUE TO VASA VASORUM ON THE ANEURYSMAL WALL. THE ENDOPROSTHESES WERE EXPLANTED EXCEPT THE LEFT LEG IN THE LEFT COMMON ILIAC ARTERY. THE PATIENT'S AORTA WAS REPLACED WITH A SURGICAL GRAFT AND ITS LEFT LEG WAS ANASTOMOSED TO THE PART OF THE ENDOPROSTHESIS REMAINED IN THE LEFT COMMON ILIAC ARTERY. THE OPEN SURGERY WAS CONCLUDED WITH NO ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151260 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8308733

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R