BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5090630 · Received September 21, 2015

    Report

    Report Number
    2017233-2015-00625
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    July 21, 2011
    Report Date
    October 12, 2015
    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

    (B)(4). RMT261418 LOT 9243067 (B)(4), PXC181200 LOT 9186838 (B)(4), PXC181000 LOT 8541795 (B)(4).

    Description of Event or Problem · 1

    ON JULY 21, 2011 IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. A. KATSARGYRIS, B. BOTOS, K. OIKONOMOU, M. PEDRAZA DE LEISTL, W. RITTER, E.L.G. VERHOEVEN, DEPARTMENT OF VASCULAR AND ENDOVASCULAR SURGERY, KLINIKUM NURNBERG SUD, NURNBERG, GERMANY, DEPARTMENT OF RADIOLOGY, KLINIKUM NURNBERG SUD, NURNBERG, GERMANY; THE NEW C3 GORE EXCLUDER STENT-GRAFT: SINGLE-CENTER EXPERIENCE WITH 100 PATIENTS. 2013 (B)(6). A TOTAL OF 100 PATIENTS WERE INCLUDED WHO WERE TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM IN A SINGLE INSTITUTION. ALL PATIENTS TREATED WITH THE C3 EXCLUDER STENT-GRAFT BETWEEN AUGUST 2010 AND JULY 2013 IN OUR INSTITUTION WERE INCLUDED. PATIENT DEMOGRAPHICS, TREATMENT INDICATION, NEED FOR INTRAOPERATIVE STENT-GRAFT REPOSITIONING, IMMEDIATE TECHNICAL SUCCESS, SURVIVAL, ENDOLEAK AND MIGRATION RATE, AND NEED FOR REINTERVENTION DURING FOLLOW-UP WERE ANALYZED. PATIENTS TREATED BOTH INSIDE AND OUTSIDE THE IFU WERE INCLUDED. THIS ARTICLE MENTIONS THAT SIX PATIENTS WERE DIAGNOSED WITH TYPE II ENDOLEAKS AND WERE FOLLOWED, AS THERE WAS NO AAA SAC ENLARGEMENT. FURTHER INFORMATION OBTAINED REVEALED PATIENT DETAILS. ON SEPTEMBER 14, 2015 W.L. GORE & ASSOCIATES, INC RECEIVED ADDITIONAL INFORMATION VIA AUTOMATICALLY ADVERSE EVENT ALERT SYSTEM ABOUT THIS PATIENT. THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A RETROSPECTIVE AND PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN EARLY DATA ON THE USE OF THE GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). MEDIDATA RAVE IS THE CLINICAL STUDY DATABASE (CSD), CAPTURING THE DATA THROUGH THE GRT 10-12 MODULE. FOLLOWING WAS REPORTED: ON (B)(6), 2015 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A FOLLOW UP VISIT. THE MEASUREMENT OF THE ANEURYSM SAC SHOWED AN INCREASE FROM 48MM TO 57 MM. ON (B)(6), 2015 THE PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE. THE ANEURYSM SAC WAS FILLED BY THE INFERIOR MESENTERIC ARTERY. THIS VESSEL WAS EMBOLIZED DURING THE EMBOLIZATION PROCEDURE AND THE TYPE II ENDOLEAK WAS SOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621611 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9243067

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R