BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4964596 · Received August 4, 2015

    Report

    Report Number
    2017233-2015-00511
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    February 13, 2013
    Report Date
    August 14, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - (B)(4).

    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) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESIS (TGT3115/8111234, TGT3415/8096651). THE PROCEDURE WAS CONCLUDED WITH NO ENDOLEAKS IDENTIFIED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED OF THE HOSPITAL. ANEURYSM DIAMETER WAS 62 MM. NO ENDOLEAKS WERE REPORTED. ON (B)(6) 2011, AT A FOLLOW-UP STUDY, THE ANEURYSM DIAMETER MEASURED 47 MM. A TYPE II ENDOLEAK WAS FOUND. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. ON (B)(6) 2012, AT A FOLLOW-UP STUDY, THE ANEURYSM DIAMETER MEASURED 49 MM. THE TYPE II ENDOLEAK REMAINED. THE PHYSICIAN DECIDED TO CONTINUE TO MONITOR THE PATIENT. ON (B)(6) 2013, AT A FOLLOW-UP STUDY, THE ANEURYSM DIAMETER MEASURED 61 MM. THE TYPE II ENDOLEAK REMAINED. THE PHYSICIAN DECIDED TO CONTINUE TO MONITOR THE PATIENT. ON (B)(6) 2014, AT A FOLLOW-UP STUDY, THE ANEURYSM DIAMETER MEASURED 59 MM. THE TYPE II ENDOLEAK REMAINED. THE PHYSICIAN DECIDED TO CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506173 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8111234

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other