BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2142811 · Received June 21, 2011

    Report

    Report Number
    2017233-2011-00298
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    February 20, 2009
    Report Date
    June 21, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO REPAIR TWO SEPARATE THORACIC AORTIC ANEURYSMS WITH A CHRONIC AORTIC DISSECTION. COIL EMBOLIZATION WAS PERFORMED ON THE LEFT SUBCLAVIAN ARTERY AND A BYPASS SURGERY USING A VASCULAR GRAFT WAS PERFORMED. THEN A GORE TAG THORACIC ENDOPROSTHESIS INTENTIONALLY COVERED THE LEFT SUBCLAVIAN ARTERY. A SECOND GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED DISTALLY IN THE DESCENDING AORTA. LATER THE SAME DAY THE PT EXPERIENCED PARAPARESIS OF THE LEFT LEG AND REQUIRED THE USE OF A WALKING STICK. THE PT HAS SINCE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG326 06553594

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O (B)(4)