BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2122956 · Received June 7, 2011

    Report

    Report Number
    2017233-2011-00265
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    November 27, 2008
    Report Date
    June 3, 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 MFG RECORDS HAS BEEN CONDUCTED. THE MFG RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT UNDERWENT TREATMENT FOR AN ANEURYSM IN THE THORACIC AORTA WITH GORE TAG THORACIC ENDOPROSTHESES. AFTER THE STENT-GRAFTS WERE SUCCESSFULLY IMPLANTED, THE EXTERNAL ILIAC ARTERY (EIA) WAS DAMAGED DURING CLOSURE OF THE ACCESS SITE. THE PHYSICIAN DECIDED TO CLOSE THE EIA, AND PERFORMED A FEM-FEM BYPASS TO RESTORE DISTAL BLOOD FLOW. THE PT TOLERATED THE PROCEDURE.

    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 06271105

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4)