BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5451379 · Received February 22, 2016

    Report

    Report Number
    2017233-2016-00146
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    January 17, 2012
    Report Date
    January 25, 2016
    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

    ADDITIONAL MANUFACTURER NARRATIVE - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/7064618-DISTAL, TGT3420/7160084-PROXIMAL). THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 81 MM. THE DIAMETER OF THE DISTAL NECK MEASURED 24-29 MM. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2010, FOLLOW-UP IMAGES SHOWED NO ENDOLEAK. THE ANEURYSM DIAMETER MEASURED 76 MM. ON (B)(6) 2010, FOLLOW-UP IMAGES SHOWED THE ANEURYSM DIAMETER MEASURED 76 MM. ON (B)(6) 2011, FOLLOW-UP IMAGES SHOWED THE ANEURYSM DIAMETER MEASURED 77 MM. ON (B)(6) 2012, FOLLOW-UP IMAGES SHOWED A DISTAL TYPE I ENDOLEAK. THE ANEURYSM DIAMETER MEASURED 82 MM. A GORE® TAG® THORACIC ENDOPROSTHESIS (TGT3420/9119484) WAS IMPLANTED TO TREAT THE ENDOLEAK. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. ON (B)(6) 2012, FOLLOW-UP IMAGES SHOWED A TYPE II ENDOLEAK. THE ANEURYSM DIAMETER MEASURED 89 MM. ON (B)(6) 2013, THE ANEURYSM DIAMETER MEASURED 98 MM. ON (B)(6) 2015, THE ANEURYSM DIAMETER MEASURED 109 MM. NO FURTHER REINTERVENTIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107666 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7064618

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R TGT3420/71600841/17/12: TGT3420/9119484