BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2444717 · Received February 3, 2012

    Report

    Report Number
    2017233-2012-00062
    Event Type
    Death
    Date Received
    February 3, 2012
    Date of Event
    August 24, 2011
    Report Date
    January 10, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) WAS NOT CONDUCTED AS THE DEVICE LOT NUMBERS WERE UNAVAILABLE. PLEASE NOTE ADDITIONAL DEVICE RELATED TO THIS EVENT: TGT3420/UNK. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. PER THE INSTRUCTIONS FOR USE FOR THE GORE TAG THORACIC ENDOPROSTHESIS: "THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT ETIOLOGIES: ACUTE AND CHRONIC DISSECTIONS. ADDITIONALLY, THE IFU STATES: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT FOR AN ACUTE TYPE B DISSECTION AND A RAPIDLY EXPANDING DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH A TYPE A DISSECTION PROXIMAL TO THE IMPLANTED ENDOPROSTHESIS. ON (B)(6) 2011, THE PATIENT UNDERWENT REPAIR FOR A TYPE A DISSECTION AND EXPIRED DUE TO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC WLG426

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| L| O| R