BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1864771 · Received October 6, 2010

    Report

    Report Number
    2017233-2010-00441
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 5, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: TYPE I ENDOLEAK. ADDITIONAL DEVICES ALSO INVOLVED IN THIS EVENT INCLUDE: TGT3115/(B)(4); TGT3115/(B)(4); TGT3110/(B)(4). THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES: COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO; ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6), 2009, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. THERE WAS A SMALL TYPE I ENDOLEAK PROXIMALLY, WHICH WAS RESOLVED WITH INTENTIONAL COVERING OF THE LEFT SUBCLAVIAN ARTERY. THE PT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK. ON (B)(6), 2010, GORE WAS MADE AWARE A PROXIMAL TYPE I AND A POSSIBLE DISTAL TYPE II ENDOLEAK WERE DETECTED AT THE PT'S F/U APPOINTMENT ON (B)(6), 2010. ON (B)(6), 2010, THE PT UNDERWENT A REINTERVENTION. THE PT WAS TREATED FOR A PROXIMAL TYPE I ENDOLEAK ORIGINATING FROM THE LEFT SUBCLAVIAN ARTERY. THE SUBCLAVIAN WAS FOUND TO HAVE A DISSECTION. A RIGHT CAROTID TO LEFT SUBCLAVIAN BYPASS WAS PERFORMED WHICH RESOLVED THE ENDOLEAK. TWO ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS WERE PLACED TO EXTEND COVERAGE DISTALLY. COVERAGE WAS EXTENDED DOWN TO THE CELIAC ARTERY. THE PT TOLERATED THE PROCEDURE.

    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 WLG326 7172648

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O| R