BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2926272 · Received January 16, 2013

    Report

    Report Number
    2017233-2013-00022
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    September 1, 2010
    Report Date
    December 19, 2012
    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

    THE REVIEW OF THE MANUFACTURING AND STERILIZATION PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATE THAT POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS INCLUDE INFECTION (E.G., ANEURYSM, DEVICE OR ACCESS SITES), AND REOPERATION. ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: TGT3420/7750959 AND TGT4020/7995346.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT A PROCEDURE USING THREE GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM. THREE MONTHS PRIOR, THE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM (AAA) BYPASS SURGERY. THE BYPASSING SURGERIES (-SMA, -CELIAC AND -BOTH RENAL ARTERIES) FROM THE AORTA USING THE VASCULAR GRAFTS WERE ALSO PERFORMED. TAG DEVICES WERE ACCESSED FROM THE CONDUIT ANASTOMOSED TO THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2010, THE PT DEVELOPED A FEVER AND WENT TO THE HOSPITAL. A COMPUTED TOMOGRAPHY (CT) REVEALED THE ANEURISMAL SAC WAS INFECTED. THE PHYSICIAN THOUGHT THERE WAS POSSIBLE INFECTION OF THE TAG DEVICES AND TREATED BY ANTIBIOTIC. THIS WAS NOT EFFECTIVE. ON (B)(6) 2010, THE PHYSICIAN ADVANCED THE DRAINAGE TUBE UNDER THE CT GUIDE AND STARTED TO ADMINISTER THE ANTIBIOTIC AGENT THROUGH THE TUBE. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24206 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06540404

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention