BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5320138 · Received December 22, 2015

    Report

    Report Number
    2017233-2015-00912
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    April 16, 2012
    Report Date
    December 7, 2015
    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

    LOT 6970814: UDI (B)(4). LOT 7517791: UDI (B)(4). ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: TGT3115/7517791 THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATE THAT POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS INCLUDE ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(4) 2010, THE PATIENT UNDERWENT A PROCEDURE USING TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC ANEURYSM. IT WAS REPORTED ON DISCHARGE DATE OF (B)(6) 2010, THE ANEURYSM MEASURED 40MM. FOLLOW UP DATES AND ANEURYSM MEASUREMENT: (B)(6) 2010, 40MM, (B)(6) 2012, 47MM, (B)(6) 2013, 49MM, (B)(6) 2014, 49MM. THERE IS ANEURYSM ENLARGEMENT OF 9MM. IT IS UNKNOWN WHY THE ANEURYSM SAC HAS ENLARGED AND THERE HAS BEEN NO REPORTED OR PLANNED REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844863 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 6970814

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other