BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4592774 · Received March 11, 2015

    Report

    Report Number
    2017233-2015-00143
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    November 27, 2012
    Report Date
    February 19, 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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM REPAIR USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/7854223, TGT3715/8027967). AT THE END OF THE PROCEDURE, A PROXIMAL TYPE I ENDOLEAK WAS FOUND. THE PHYSICIAN PERFORMED BALLOONING TO TREAT THE ENDOLEAK. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. THE ANEURYSM MEASURED 56 MM. SUBSEQUENT FOLLOW-UP EXAMINATIONS REVEALED NO ADVERSE EVENTS. ON (B)(6) 2011, A ONE YEAR FOLLOW-UP EXAMINATION REVEALED THE ANEURYSM MEASURED 39 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2012, A TWO YEAR FOLLOW-UP EXAMINATION REVEALED THE ANEURYSM NOW MEASURED 44 MM. ON (B)(6) 2013, A THREE YEAR FOLLOW-UP EXAMINATION REVEALED THE ANEURYSM STILL MEASURED 44 MM, AND TYPE II ENDOLEAK WAS FOUND. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168613 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8027967

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other (B)(6) 2010: TGT3415/7854223