BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2920206 · Received January 10, 2013

    Report

    Report Number
    3007284313-2013-00002
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    W.L. GORE & ASSOCAITES
    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

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

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT A PROCEDURE USING THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PROCEDURE ENDED WITHOUT ENDOLEAK. ON (B)(6) 2012, FOLLOW-UP COMPUTER TOMOGRAPHY ANGIOGRAPHY REVEALED THAT THE DISTAL NECK OF THE PXC141400 ON THE LEFT SIDE HAD MIGRATED TOWARDS THE ANEURYSM 1 CM, REPORTEDLY RESULTING IN A DISTAL TYPE I ENDOLEAK. IT WAS REPORTED THAT WHEN THE PHYSICIAN INITIALLY IMPLANTED THE DEVICES, A STIFF GUIDEWIRE WAS USED TO STRAIGHTEN THE ANATOMY. AFTER THE WIRE WAS REMOVED, THE CONTRALATERAL LEG WAS REPORTEDLY PULLED BY STRESS AND MOVED TOWARDS THE ANEURYSM SAC. NO ANEURYSM ENLARGEMENT WAS IDENTIFIED. ON (B)(6) 2012, THE PHYSICIAN IMPLANTED AN ADDITIONAL CONTRALATERAL LEG COMPONENT TO EXTENDED THE LEFT SIDE. THE ENDOLEAK RESOLVED, AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15730 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCAITES 10385694

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R