BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3010962 · Received March 7, 2013

    Report

    Report Number
    2017233-2013-00117
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    November 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE STERILIZATION AND MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATES THAT POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS INCLUDE INFECTION (E.G. ANEURYSM, DEVICE OR ACCESS SITES), AND ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS. ON (B)(6) 2012, A COMPUTED TOMOGRAPHY (CT) SHOWED A DISTAL TYPE I ENDOLEAK. THE CAUSE OF THE ENDOLEAK IS UNK. THE CT REVEALED AN UNK DENSITY ADJACENT TO THE DEVICE, CONSISTENT WITH AIR. UPON FURTHER INVESTIGATION IT WAS DETERMINED THE DENSITY WAS AN INFECTION. THE PT WAS ILL WITH SEPSIS AND NO INTERVENTION IS PLANNED. IT WAS REPORTED ON (B)(6) 2012, THE PT PASSED AWAY AND THE CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98446 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9879118

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Life Threatening