BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 3964583 · Received July 29, 2014

    Report

    Report Number
    2017233-2014-00378
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    April 9, 2014
    Report Date
    July 3, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT MEDICATIONS INCLUDE ADIRO (ACETYL SALYCILIC ACID 100 MG/24H), PANTOPRAZOL (PROTON-PUMP INHIBITOR) 20 MG/24H, ENALAPRIL 5 MG/24H (ACE INHIBITOR). A REVIEW OF THE MANUFACTURING PAPERWORK 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 AND REOPERATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH TWO CONFORMABLE GORE® TAG® ENDOPROSTHESES [TGE313115/11789038 (PROXIMAL) AND TGE343415/11531951 (DISTAL)] TO TREAT A DESCENDING THORACIC AORTIC ANEURYSM. ON (B)(6) 2013, COMPUTED TOMOGRAPHIC ANGIOGRAPHY REVEALED A DISTAL TYPE I ENDOLEAK. NO ANEURYSMAL ENLARGEMENT WAS REPORTED. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. ON AN UNKNOWN DATE IN (B)(6) 2014, FOLLOW-UP IMAGING CONFIRMED THE DISTAL TYPE I ENDOLEAK. ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH TWO ADDITIONAL STENT GRAFTS TO TREAT THE TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440980 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11531951

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R