BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2834095 · Received November 6, 2012

    Report

    Report Number
    2017233-2012-00747
    Event Type
    Death
    Date Received
    November 6, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL TAG COMPONENTS INCLUDED IN THIS REPORT: (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO ENDOPROSTHESIS INFECTION AND DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESES TO TREAT A SUSPECTED AORTOESOPHAGEAL FISTULA. ON AN UNKNOWN DATE, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED A POSSIBLE ENDOGRAFT INFECTION, AND A LARGE HIATAL HERNIA WITH STOMACH AND COLON CONTENTS IN THE THORACIC CAVITY. ACCORDING TO THE HOSPITAL IMAGING REPORT, ABNORMAL FLUID COLLECTION WITH GAS LUCENCY SEEN WITHIN THE LEFT LOWER CHEST ABOUT THE POST-OPERATIVE LOWER THORACIC AORTA MAY REPRESENT NECROTIZING PNEUMONIA, EMPYEMA, OR INFECTION OF THE GRAFT. ON MAY(B)(6) 2011, THE PT EXPIRED.

    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 06758952

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death COLACE| ZOFRAN| ALBUTEROL| BISOPROLOL| DETROL| VICODIN| PROTONIX| REGLAN| MILK OF MAGNESIA