BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1944445 · Received December 28, 2010

    Report

    Report Number
    2953161-2010-00231
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 27, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2006, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2010, THIS PT PRESENTED WITH LEG PAIN AND LOSS OF SENSATION AND WAS DETERMINED TO HAVE CLAUDICATION AND A THROMBOSED DEVICE LEFT LIMB. ON (B)(6), 2010, A REINTERVENTION OCCURRED WHEREBY THE PHYSICIAN ANGIO-JETTED AND THROMBECTOMIZED THE PT'S THROMBOSED LEFT LIMB (PXC). TWO ADD'L BARD LIFESTENT VASCULAR STENTS (12X80) WERE IMPLANTED AT THE LEVEL OF THE PXC. THE PT TOLERATED THE PROCEDURE. THE OUTFLOW PROBLEM CAUSED THROMBOSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG425 04309694

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R