BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2973931 · Received February 14, 2013

    Report

    Report Number
    2017233-2013-00073
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 21, 2011
    Report Date
    January 30, 2013
    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

    RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE 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) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. ON (B)(6) 2011, THE PATIENT UNDERWENT RE-INTERVENTION AND THE ENDOLEAK WAS RESOLVED WITH THE PLACEMENT OF AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS PROXIMALLY TO FURTHER SEAL THE ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66233 GORE TAG THORACIC ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 8401039

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R