BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1871287 · Received October 13, 2010

    Report

    Report Number
    2017233-2010-00450
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 12, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED SINCE THE DEVICE LOT SERIAL NUMBER IS UNAVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT TO TREAT A PROXIMAL TYPE I ENDOLEAK FROM A PREVIOUSLY IMPLANTED MEDTRONIC TALENT DEVICE. THE ENDOLEAK WAS NOT RESOLVED SO, THE DECISION WAS MADE TO IMPLANT A PALMAZ STENT. THE ENDOLEAK WAS STILL NOT RESOLVED. THE PROXIMAL AREA WAS BALLOONED WITH A CORDIS BALLOON TO TRY TO RESOLVE THE ENDOLEAK. THE PT'S AORTA RUPTURED. THE PT WAS CONVERTED TO AN OPEN REPAIR. THE PT TOLERATED THE PROCEDURE. NO FURTHER INFO IS AVAILABLE TO GORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R