BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1346527 · Received March 16, 2009

    Report

    Report Number
    2017233-2009-00149
    Event Type
    Death
    Date Received
    March 16, 2009
    Date of Event
    April 5, 2007
    Report Date
    March 13, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN PATIENT'S WITH ACUTE DISSECTIONS AND RUPTURED ANEURYSMS. ADDITIONAL DEVICE IMPLANTED IN 2007 AND INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    IN 2006, THIS PT WAS TREATED WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A TYPE A DISSECTION STARTING AT THE LEFT COMMON CAROTID EXTENDING PAST THE CELIAC ARTERIES. IN 2007, THE PT UNDERWENT A SECOND PROCEDURE DURING WHICH A SECOND GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED DUE TO A PERSISTENT TYPE I ENDOLEAK. THE PT TOLERATED THE PROCEDURE. IN LATE 2008, THE PT PRESENTED WITH SPINAL CORD NEUROLOGIC CONDITIONS FOR WHICH THE PT REFUSED ANY FURTHER TREATMENT OR SURGERIES AND WAS PLACED IN HOSPICE CARE. THE PT EXPIRED IN EARLY 2009. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS THE PRE-EXISTING CONDITION OF DISTAL DISSECTION OF THE ENTIRE AORTA WITH ANEURYSM RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES, INC. WLG326 03620985

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death