BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4684734 · Received April 13, 2015

    Report

    Report Number
    2017233-2015-00225
    Event Type
    Injury
    Date Received
    April 13, 2015
    Date of Event
    April 26, 2010
    Report Date
    March 18, 2015
    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 PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TG3710/06258771, PROXIMALLY, AND TG3115/7327683 DISTALLY) TO REPAIR A THORACIC AORTIC ANEURYSM WITH DIAMETER OF 56 MM. RETROPERITONEAL APPROACH WAS ELECTED AND A SURGICAL ACCESS WAS OBTAINED FROM BIFURCATION OF THE ILIAC ARTERY. THE LEFT SUBCLAVIAN ARTERY WAS COIL EMBOLIZED. NO ISSUES WERE IDENTIFIED DURING THE PROCEDURE. ON (B)(6) 2010, POST-OPERATIVE FOLLOW-UP EXAMINATION REVEALED A PROXIMAL TYPE I ENDOLEAK AND A TYPE III (DETAILS UNKNOWN) ENDOLEAK. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ON (B)(6) 2010, A ONE MONTH FOLLOW-UP EXAMINATION SHOWED THAT THE ENDOLEAKS PERSISTED. IT ALSO REVEALED THAT THE PATIENT DEVELOPED AN ILEUS, WHICH WAS TREATED WITH FASTING THERAPY AND INTRAVENOUS THERAPY. THE CAUSE OF THE ILEUS IS UNKNOWN; HOWEVER IT WAS REPORTEDLY PROCEDURE RELATED. ON (B)(6) 2010, THREE MONTH FOLLOW-UP EXAMINATION SHOWED THAT THE ENDOLEAKS PERSISTED. IT WAS ALSO CONFIRMED THAT THE PATIENT RECOVERED FROM THE ILEUS. ON (B)(6) 2010, A SIX MONTH FOLLOW-UP EXAMINATION SHOWED THAT THE ENDOLEAKS PERSISTED. ON (B)(6) 2011, A ONE YEAR FOLLOW-UP EXAMINATION SHOWED THAT THE TYPE III ENDOLEAK WAS RESOLVED; HOWEVER THE PROXIMAL TYPE I ENDOLEAK STILL PERSISTED, AND THE ANEURYSM MEASURED 64 MM. ON (B)(6) 2011, AN ADDITIONAL PROCEDURE WAS PERFORMED TO REPAIR THE PROXIMAL TYPE I ENDOLEAK WHEREBY A GORE® TAG® THORACIC ENDOPROSTHESIS (TGT3715/8914885) WAS IMPLANTED TO EXTEND THE PROXIMAL NECK. THE FINAL ANGIOGRAPHY SHOWED THAT THE ENDOLEAK SLIGHTLY REMAINED, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE ADDITIONAL PROCEDURE. SUBSEQUENT FOLLOW-UP EXAMINATION SHOWED THAT THE ENDOLEAK PERSISTED. ON (B)(6) 2013, THE PATIENT EXPIRED DUE TO ASPIRATION PNEUMONIA CAUSED BY AN ILEUS. THE PATIENT'S DEATH IS REPORTEDLY NOT DEVICE OR PROCEDURE RELATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244476 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06258771

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R (B)(6) 10: TG3115/7327683 8/16/11: TGT3715/8914885