BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4120149 · Received September 25, 2014

    Report

    Report Number
    2017233-2014-00501
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    September 4, 2013
    Report Date
    September 26, 2014
    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

    EVENT DATE.: ESTIMATED DATE OF EVENT. IMPLANT DATE: ESTIMATED DATE OF IMPLANT. 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 INFECTION. A REVIEW OF THE MANUFACTURING AND STERILIZATION PAPERWORK COULD NOT BE PERFORMED AS THE LOT NUMBERS WERE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE STERILIZATION PAPERWORK 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 INFECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A CHRONIC TYPE B DISSECTION USING TWO GORE TAG THORACIC ENDOPROSTHESES. ON (B)(6) 2013, THE PATIENT PRESENTED WITH A FEVER AND A BACK PAIN. A BLOOD CULTURE RESULT INDICATED STAPHYLOCOCCUS EPIDERMIDIS, AND THE PATIENT WAS SUSPECTED OF A GRAFT INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE TREATMENT OF INFECTION. ANTIBIOTIC TREATMENT WAS STARTED. AFTER ABOUT ONE MONTH OF ANTIBIOTIC ADMINISTRATION, CRP DID NOT DECLINE. ON (B)(6) 2013, CT IMAGES SHOWED THE ENLARGEMENT OF THE FALSE LUMEN OF THE DISSECTION. THE PATIENT WAS DIAGNOSED AS FALSE LUMEN INFECTION. THE PATIENT UNDERWENT AN OPEN THORACIC SURGERY TO TREAT THE FALSE LUMEN INFECTION OF THE TYPE B DISSECTION. THE TAG DEVICES WERE EXPLANTED AND REPLACED WITH A VASCULAR GRAFT. OMENTUM PATCH WAS ALSO PLACED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT DID WELL AFTER THE SURGICAL INTERVENTION AND WAS DISCHARGED FROM THE HOSPITAL 14 DAYS AFTER THE OPEN SURGERY. THE PHYSICIAN REPORTEDLY SUSPECTED A POSSIBILITY OF THE PROCEDURE RELATED INFECTION DUE TO INADEQUATE HYGIENE IN THE OPERATION ROOM AT THE TIME.

    Description of Event or Problem · 1

    ON UNKNOWN DATE IN 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A CHRONIC TYPE B DISSECTION USING TWO GORE® TAG® THORACIC ENDOPROSTHESES. 16 MONTHS LATER, THE PATIENT PRESENTED WITH A FEVER AND A BACK PAIN. A BLOOD CULTURE RESULT INDICATED STAPHYLOCOCCUS EPIDERMIDIS, AND THE PATIENT WAS SUSPECTED OF A GRAFT INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE TREATMENT OF INFECTION. ANTIBIOTIC TREATMENT WAS STARTED. AFTER ABOUT ONE MONTH OF ANTIBIOTIC ADMINISTRATION, CRP DID NOT DECLINE. CT IMAGES SHOWED THE ENLARGEMENT OF THE FALSE LUMEN OF THE DISSECTION. THE PATIENT WAS DIAGNOSED AS FALSE LUMEN INFECTION. 28 DAYS AFTER THE SECOND HOSPITALIZATION, THE PATIENT UNDERWENT AN OPEN THORACIC SURGERY TO TREAT THE FALSE LUMEN INFECTION OF THE TYPE B DISSECTION. THE TAG DEVICES WERE EXPLANTED AND REPLACED WITH A VASCULAR GRAFT. OMENTUM PATCH WAS ALSO PLACED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT DID WELL AFTER THE SURGICAL INTERVENTION AND WAS DISCHARGED FROM THE HOSPITAL 14 DAYS AFTER THE OPEN SURGERY. THE PHYSICIAN REPORTEDLY SUSPECTED A POSSIBILITY OF THE PROCEDURE RELATED INFECTION DUE TO INADEQUATE HYGIENE IN THE OPERATION ROOM AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599034 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9768109

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R IMPLANTED ON(B)(6)2011 (EST.): TG4020/LOT# UNKNOWN