BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122502 · Received May 15, 2013

    Report

    Report Number
    2017233-2013-00307
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT UNDERWENT EMERGENT REPAIR OF A 12 CM ABDOMINAL AORTIC ANEURYSM WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES FEATURING THE C3 DELIVERY SYSTEM. IT WAS REPORTED THE PATIENT'S PROXIMAL NECK WAS SHORT AND ANGULATED, MEASURING 2.2 CM IN LENGTH AND 90 DEGREES IN ANGULATION. IT WAS REPORTED THE TRUNK-IPSILATERAL LEG COMPONENT MOVED DISTALLY DURING DEPLOYMENT (AMOUNT UNKNOWN) DUE TO LACK OF SEAL ZONE IN THE PROXIMAL NECK. THE DEVICE WAS LEFT WHERE IT LANDED, THE PROCEDURE WAS CONCLUDED. FINAL ANGIOGRAM SHOWED EXCLUSION OF THE ANEURYSM, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2013, FOLLOW-UP IMAGING SHOWED A PROXIMAL TYPE I ENDOLEAK REPORTEDLY DUE TO THE SHORT AND ANGULATED NECK. THE SAME DAY, AN INTERVENTION WAS PERFORMED WHEREBY TWO AORTIC EXTENDER COMPONENTS WERE IMPLANTED, AND STAPLES WERE PLACED PROXIMALLY TO STABILIZE AND SECURE THE GRAFTS. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214337 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10991027

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R TOPROL| LABORALL| COLACE| PREDNISONE| BACTRIM| AMBIEN| CELLCEPT