BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5624395 · Received May 2, 2016

    Report

    Report Number
    2017233-2016-00424
    Event Type
    Injury
    Date Received
    May 2, 2016
    Date of Event
    July 28, 2010
    Report Date
    April 4, 2016
    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

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ULCER-LIKE PROJECTION (ULP) IN THE THORACIC AORTA USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT3420/7842908 AND TGT3410/06821962). TGT3410 WAS IMPLANTED PROXIMALLY AND TGT3420 WAS DEPLOYED DISTALLY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2010, FOLLOW-UP IMAGING REVEALED A MINOR PROXIMAL TYPE I ENDOLEAK. A WAIT-AND-WATCH APPROACH WAS TAKEN TO THE ENDOLEAK. ON (B)(6) 2010, IN ONE-MONTH FOLLOW-UP STUDY, THE PROXIMAL TYPE I ENDOLEAK REMAINED. ANEURYSM DIAMETER WAS 45 MM. ON (B)(6) 2011, IN SIX-MONTH FOLLOW-UP STUDY, THE PROXIMAL TYPE I ENDOLEAK WAS STILL PRESENT. ANEURYSM DIAMETER WAS 43 MM. ON (B)(6) 2011, A PSEUDOANEURYSM WAS REVEALED AT THE DISTAL EDGE OF THE TGT3420. THE PHYSICIAN COMMENTED THAT THE PSEUDOANEURYSM MAY HAVE BEEN CAUSED BY THE TAG DEVICE. THE PATIENT WAS IMPLANTED WITH ADDITIONAL ENDOPROSTHESES (MANUFACTURER UNKNOWN) TO REPAIR THE PSEUDOANEURYSM. ON (B)(6) 2011, IN ONE-YEAR FOLLOW-UP STUDY, THE PERSISTENT PROXIMAL TYPE I ENDOLEAK STILL REMAINED. THE ENDOLEAK WAS MONITORED. ANEURYSM DIAMETER WAS 41 MM. ON (B)(6) 2012, IN TWO-YEAR FOLLOW-UP STUDY, ANEURYSM DIAMETER WAS 44 MM. ENDOLEAKS COULD NOT BE IDENTIFIED. IN TWO FOLLOW-UP STUDIES PERFORMED, ENDOLEAKS COULD NOT BE IDENTIFIED. ANEURYSM DIAMETER WAS 43 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278668 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7842908

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R (B)(6) 2010: TGT3410/06821962