BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5242767 · Received November 23, 2015

    Report

    Report Number
    2017233-2015-00827
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    May 25, 2013
    Report Date
    October 26, 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. (B)(4). USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS 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 ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT2815/7771025, PROXIMALLY AND TGT2815/7771024, DISTALLY). NO ISSUES WERE REPORTED DURING THE PROCEDURE, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, POST-OPERATIVE FOLLOW-UP IMAGING SHOWED NO ISSUES. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. SUBSEQUENT FOLLOW-UP IMAGING SHOWED NO ISSUES WITH THE ANEURYSM DIAMETER MEASURING 40 MM. ON (B)(6) 2013, THREE YEAR FOLLOW-UP IMAGING REVEALED A TYPE II ENDOLEAK OF UNKNOWN ORIGIN, AND THE ANEURYSM DIAMETER MEASURING 42 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2014, FOUR YEAR FOLLOW-UP IMAGING SHOWED THAT THE ENDOLEAK PERSISTED WITH THE ANEURYSM DIAMETER MEASURING 47 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774181 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7771025

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other TGT2815/7771024