BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1332342 · Received February 26, 2009

    Report

    Report Number
    2953161-2009-00052
    Event Type
    Injury
    Date Received
    February 26, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 25, 2009
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 SPECS. OTHER DEVICE IMPLANTED BUT NOT RELATED TO THE EVENT: PXC121200, CONTRALATERAL LEG COMPONENT.

    Description of Event or Problem · 1

    IN 2008, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM WITH A DISSECTION LEADING INTO THE LEFT COMMON ILIAC (LCI) ARTERY. POST-PROCEDURE, THE PT EXPERIENCED CLAUDICATION IN THE RIGHT LEG. IN 2009, A FOLLOW-UP CTA DEMONSTRATED INVAGINATION OF THE TRUNK-IPSILATERAL LEG COMPONENTS IN THE LCI ARTERY WITH THE DEVICE BEING APPROX FIFTY-PERCENT OCCLUDED. THE FOLLOWING MONTH, A REINTERVENTION OCCURRED WHEREBY BALLOON ANGIOPLASTY WAS PERFORMED TO REPAIR THE INVAGINATED LIMB. FINAL ANGIOGRAPHY SHOWED THE COLUMN OF CONTRAST IN THE LEFT LIMB APPEARING TO BE WIDER. THE PT TOLERATED THE PROCEDURE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 06418420

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention