BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3092371 · Received April 30, 2013

    Report

    Report Number
    2017233-2013-00268
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    October 4, 2010
    Report Date
    April 3, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    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

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE INSTRUCTIONS FOR USE, KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDED SEVERE NECK ANGULATION. AS REPORTED, NECK ANGULATION WAS 125 DEGREES.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PT UNDERWENT A PROCEDURE USING TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM. TG3420/06550693 WAS FIRST IMPLANTED PROXIMALLY, AND THEN TG3715/06490729 WAS IMPLANTED DISTALLY. THE LENGTH OF THE DISTAL LANDING ZONE WAS ABOUT 20MM. THE DISTAL NECK ANGULATION WAS 125 DEGREES. THE ANEURYSM WAS 76MM. ON (B)(6) 2010, ONE YEAR FOLLOW UP COMPUTED TOMOGRAPHY SHOWED THE ENDOLEAK OF UNK ORIGIN. THE PHYSICIAN DETERMINED TO MONITOR THE PT. THE ANEURYSM WAS 76 MM. ON (B)(6) 2011, TWO ADD'L TAG DEVICES WERE IMPLANTED TO TREAT THE UNK ENDOLEAK. ON (B)(6) 2012, FOLLOW UP COMPUTED TOMOGRAPHY SHOWED THE ENDOLEAK OF UNK ORIGIN PERSISTED. THE ANEURYSM SIZE WAS 95 MM. NO ADD'L PROCEDURE HAS BEEN PERFORMED. THE PT IS UNDER OBSERVATION. PLEASE NOTE: THIS REPORT IS ON THE TG3420-06550693 IMPLANTED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188189 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTE, ENDOVASCULAR GRAFT, AORTIC ANEURYSIM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 06550693

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R TG3715/06490729