BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2911125 · Received January 7, 2013

    Report

    Report Number
    2017233-2013-00008
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 10, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE ADDITIONAL DEVICE RELATED TO THIS EVENT: PXC141200/ 7541881. METHOD: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) IS BEING CONDUCTED. CONCLUSIONS: 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. 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, ANEURYSM ENLARGEMENT. ADDITIONALLY, THE IFU STATES "THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USA (IFU) SPECIFIES "PATIENTS SHOULD BE COUNSELED AS TO THE POSSIBILITY OF SUBSEQUENT REINTERVENTIONS INCLUDING CATHETER-BASED AND OPEN SURGICAL CONVERSION."

    Description of Event or Problem · 1

    IN (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. THE DISTAL LANDING ZONE WAS REPORTED TO HAVE SIGNIFICANT CALCIUM PRESENT. PREOPERATIVE CASE PLANNING DETERMINED THE ANEURYSM HAD A MAXIMUM DIAMETER OF 51MM. ON (B)(6) 2012, THE PATIENT UNDERWENT RE-INTERVENTION AND DIGITAL SUBTRACTION ANGIOGRAPHY AND EMBOLIZATION WERE PERFORMED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7978 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7791805

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| O| R