BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5509413 · Received March 17, 2016

    Report

    Report Number
    2017233-2016-00256
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    August 10, 2010
    Report Date
    March 28, 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

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES -ON (B)(6) 2010: TG3115/7172834, TGT2815/7319199. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.(B)(4).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING THREE GORETAGTHORACIC ENDOPROSTHESES (TG2610/7001076, TG3115/7172834, AND TGT2815/7319199). ANEURYSM DIAMETER WAS 51 MM. ON (B)(6) 2010, FOLLOW UP REVEALED THE ANEURYSM MEASURED 52 MM. ON (B)(6) 2011, FOLLOW UP REVEALED THE ANEURYSM MEASURED 52 MM. ON (B)(6) 2012, FOLLOW UP REVEALED THE ANEURYSM MEASURED 55 MM. ON (B)(6) 2013, FOLLOW UP REVEALED THE ANEURYSM MEASURED 54 MM. ON (B)(6) 2013, FOLLOW UP REVEALED THE ANEURYSM MEASURED 55 MM. ON (B)(6) 2015, FOLLOW UP REVEALED THE ANEURYSM MEASURED 56 MM. THE CAUSE OF THE ANEURYSM ENLARGEMENT WAS NOT REPORTED. NO INTERVENTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163679 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7001076

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other