BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4120339 · Received September 26, 2014

    Report

    Report Number
    2017233-2014-00504
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    November 16, 2011
    Report Date
    December 2, 2014
    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

    PLEASE NOTE THAT THE PREVIOUS EVENT WITH THE SAME PATIENT WAS REPORTED IN MEDWATCH #2017233-2011-00069 ON (B)(6) 2011. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS (DISTAL) AND A MEDTRONIC TALENT® THORACIC STENT GRAFT SYSTEM (PROXIMAL). THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 69.9MM. ON (B)(6) 2011, ONE YEAR FOLLOW-UP EXAMINATION SHOWED THE PERSISTENT TYPE III ENDOLEAK WHICH WAS ONCE RESOLVED BY THE RE-INTERVENTION PERFORMED ON (B)(6) 2011. THE ANEURYSM DIAMETER MEASURED 73MM. (B)(6) 2011, THREE ZENITH® TX2® TAA ENDOVASCULAR GRAFTS (COOK MEDICAL) WERE IMPLANTED TO RELINE THE PREVIOUSLY IMPLANTED DEVICES. THE ENDOLEAK WAS RESOLVED. ON (B)(6) 2014, THREE YEAR FOLLOW-UP EXAMINATION SHOWED NO ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601914 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8325115

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R