BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5319003 · Received December 22, 2015

    Report

    Report Number
    2017233-2015-00902
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    July 6, 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

    (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). 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)(6) 2009, THE PATIENT UNDERWENT A PROCEDURE USING GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC ANEURYSM. IT WAS REPORTED ON DISCHARGE DATE OF (B)(6) 2009, THE ANEURYSM MEASURED 52MM. FOLLOW UP DATES AND ANEURYSM MEASUREMENT: (B)(6) 2010, 56MM, (B)(6) 2010, 53.8MM, (B)(6) 2011, 56MM, (B)(6) 2012, 58MM, (B)(6) 2013, 58MM, (B)(6) 2014, 58. THERE IS ANEURYSM ENLARGEMENT OF 6MM. 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
    844709 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06583944

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other