BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1651411 · Received April 2, 2010

    Report

    Report Number
    2017233-2010-00143
    Event Type
    Injury
    Date Received
    April 2, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 31, 2010
    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

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B) (6) 2009, THE PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM. THE FINAL ANGIOGRAM REVEALED A DISTAL TYPE I ENDOLEAK, BUT THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. ON (B) (6) 2010, A COMPUTED TOMOGRAPHY REVEALED A CONTINUOUS DISTAL TYPE I ENDOLEAK. ON (B) (6) 2010, THE PT WAS IMPLANTED WITH 2 GORE TAG THORACIC ENDOPROSTHESES TO TREAT THE DISTAL TYPE I ENDOLEAK. THE 2ND GORE TAG THORACIC ENDOPROSTHESIS DEVICE (TG3115/7001126) WAS INSERTED THROUGH AN AORTA CONDUIT USING A 10 MM VASCULAR GRAFT. THE AORTA CONDUIT WAS USED AS A PERMANENT AORTA-FEMORAL BYPASS TO TREAT THE OCCLUDED RIGHT ILIAC ARTERY. THE BLOOD FLOW TO THE LOWER LIMB WAS RESTORED. THE TYPE I ENDOLEAK WAS RESOLVED AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG326 06664233

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R TG3115/7001126| TG3110/06394712| TG3115/7244619