BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2253976 · Received September 14, 2011

    Report

    Report Number
    2017233-2011-00473
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 13, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. IT WAS REPORTED THAT THE AORTIC NECK DIAMETER WAS 23.8 MM. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE INTENDED TREATMENT DIAMETER FOR THE (B)(4) IS 24.0-26.0 MM.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PT WAS IMPLANTED WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE GORE C3 DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. BY (B)(6), 2011, IT WAS REPORTED THAT DEVICE HAD MIGRATED DISTALLY 15 MM LEADING TO A TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT. ON (B)(6), 2011, THE PT UNDERWENT A REINTERVENTION TO IMPLANT AN AORTIC EXTENDER COMPONENT WHICH RESOLVED THE ENDOLEAK.

    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 8558775

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R