BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4467502 · Received January 30, 2015

    Report

    Report Number
    2017233-2015-00046
    Event Type
    Injury
    Date Received
    January 30, 2015
    Date of Event
    April 3, 2012
    Report Date
    February 2, 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

    ADDED A POSSIBLE CAUSE OF THE DISTAL TYPE I ENDOLEAK THAT HAS BEEN OBTAINED.

    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) 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC DISSECTION USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3115/7905052, TGT3715/7662385). THE PATIENT TOLERATED THE PROCEDURE WITH NO ENDOLEAKS OR ADVERSE EVENTS REVEALED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED OF THE HOSPITAL. ANEURYSM DIAMETER WAS 60MM AT THE TIME OF HOSPITAL DISCHARGE. IN LATER FOLLOW-UP STUDIES, ENDOLEAKS OR OTHER ADVERSE EVENTS HAD NOT OCCURRED TO THE PATIENT. ON (B)(6) 2012, A DISTAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS REVEALED. ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL GORE® TAG® THORACIC ENDOPROSTHESIS TO TREAT THE DISTAL TYPE I ENDOLEAK. ON (B)(6) 2012, IN TWO-YEAR FOLLOW-UP STUDY, THE ANEURYSM DIAMETER WAS 67MM.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC DISSECTION USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT3115/7905052, TGT3715/7662385). THE PATIENT TOLERATED THE PROCEDURE WITH NO ENDOLEAKS OR ADVERSE EVENTS REVEALED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED OF THE HOSPITAL. ANEURYSM DIAMETER WAS 60MM AT THE TIME OF HOSPITAL DISCHARGE. IN LATER FOLLOW-UP STUDIES, ENDOLEAKS OR OTHER ADVERSE EVENTS HAD NOT OCCURRED TO THE PATIENT. ON (B)(6) 2012, A DISTAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS REVEALED. ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS TO TREAT THE DISTAL TYPE I ENDOLEAK. ON (B)(6) 2012, IN TWO-YEAR FOLLOW-UP STUDY, THE ANEURYSM DIAMETER WAS 67MM. IT WAS REPORTED THAT THERE WAS A DESCENDING THORACIC AORTIC ANEURYSM IN AN AREA DISTAL TO WHERE A TAG DEVICE WAS IMPLANTED, AND THIS ANEURYSM HAD CHANGED ITS SHAPE, WHICH MIGHT HAVE CAUSED THE DISTAL TYPE I ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70278 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7905052

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R TGT3715/7662385