BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1982277 · Received February 1, 2011

    Report

    Report Number
    2017233-2011-00050
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 31, 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

    FOUR YEARS AGO (EXACT DATE UNK), THE PT UNDERWENT OPEN REPAIR OF A TYPE B DISSECTION WHERE STENT GRAFTS WERE IMPLANTED. ON (B)(6) 2011, THE PT UNDERWENT REPAIR OF AN EXTENSION OF THE DISSECTION. THE PHYSICIAN IMPLANTED THE GUIDE WIRE THROUGH THE STENT GRAFT WHICH WAS IMPLANTED IN A TORTUOUS POSITION. THE GORE TAG THORACIC ENDOPROSTHESIS WAS FORCIBLY ADVANCED DUE TO THE SEVERE TORTUOSITY. THE DEPLOYMENT KNOB WAS PULLED AND THE DELIVERY CATHETER MOVED DISTALLY. THE DEPLOYMENT LINE BROKE AND THE DEVICE ONLY PARTIALLY DEPLOYED. THE PT WAS CONVERTED TO OPEN REPAIR WHERE THE GORE TAG THORACIC ENDOPROSTHESIS WAS EXPLANTED. THE PT TOLERATED THE PROCEDURE. THE DEVICE HAS BEEN RETURNED TO GORE AND IS UNDER EVALUATION.

    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 WLG426 8463973

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R