BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 6438374 · Received March 28, 2017

    Report

    Report Number
    2017233-2017-00172
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    July 1, 2007
    Report Date
    April 11, 2017
    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

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER REMAINS UNKNOWN. ACCORDING TO THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: STROKE.

    Additional Manufacturer Narrative · 1

    A COPY OF THE ARTICLE WAS ATTACHED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS PRESENTED ON THE CONFERENCE ¿ ¿THE 47TH ANNUAL MEETING OF THE (B)(6)¿ ON (B)(6) 2017. AKIHIRO MIZUNO ET AL, ¿TREATMENT OUTCOME OF ENDOVASCULAR PROCEDURE FOR ARCH ANEURYSM PATIENTS IN OUR HOSPITAL¿. BETWEEN JULY 2007 AND JULY 2016, 85 PATIENTS UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR WITH DEBRANCHING. A GORE® TAG® THORACIC ENDOPROSTHESIS OR A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED IN 14 PATIENTS. IT WAS PRESENTED THAT CEREBRAL INFARCTION WAS DEVELOPED IN TWO PATIENTS TREATED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS AND ONE PATIENT TREATED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223542 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other