BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1851619 · Received September 29, 2010

    Report

    Report Number
    2017233-2010-00431
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 28, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. RESULTS - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: ENDOLEAK. ADDITIONAL DEVICES RELATED TO THIS EVENT ARE: PXC20100/(B)(4). THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), STATES: ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO; ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THE PATIENT'S ILIAC ARTERIES WERE SOMEWHAT TORTUOUS, WHICH WHAT APPEARED TO BE STENOSIS IN THE RIGHT COMMON ILIAC. THE PATIENT TOLERATED THE PROCEDURE WITH COMPLETION ANGIOGRAPHY SHOWING NO EVIDENCE OF AN ENDOLEAK. ON (B)(6), 2010, THE GORE FIELD SALES ASSOCIATE (FSA) WAS INFORMED THE PATIENT WAS SCHEDULED FOR AN ANGIOGRAM ON (B)(6), 2010. THE ANGIOGRAM IS TO DETERMINE IF A TYPE I OR II ENDOLEAK EXISTS AND IF THE DEVICE MIGRATED. ON (B)(6), 2010, A POSSIBLE TYPE I ENDOLEAK WILL HAVE PERSISTED 30 DAYS. THE PATIENT IS ASYMPTOMATIC AND THERE IS NO ENLARGEMENT OF THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANERUYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 06650853

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other