BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 699600 · Received April 12, 2006

    Report

    Report Number
    2953161-2006-00021
    Event Type
    Injury
    Date Received
    April 12, 2006
    Date of Event
    March 16, 2006
    Report Date
    April 11, 2006
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE BIFURCATED ENDOPROSTHESIS WITHOUT INCIDENT. FOLLOWING THE SUCCESSFUL IMPLANTATION OF THE DEVICE, THE PATIENT BEGAN TO EXPERIENCE PARAPLEGIA. THREE HOURS POST IMPLANT; THE PHYSICIAN EXPLANTED THE DEVICE AND SURGICALLY REPAIRED THE VESSLE. THE PATIENT DID NOT REPORT TO HAVE ANY PRIOR HISTORY OF THORACIC AORTA SURGERY. THE PATIENT WAS REPORTED TO HAVE PERMANENT PARAPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 04193926

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention