BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 6652625 · Received June 19, 2017

    Report

    Report Number
    2017233-2017-00310
    Event Type
    Injury
    Date Received
    June 19, 2017
    Date of Event
    October 11, 2016
    Report Date
    May 24, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. TGU404015/13809990 UDI# (01)00733132618163(17)180331(21)13809990. IT IS UNKNOWN WHICH OF THE 4 IMPLANTED GORE® TAG® THORACIC ENDOPROSTHESES HAD THE REPORTED ENDOLEAK, THEREFORE ALL DEVICES HAVE BEEN INCLUDED IN THE REPORT: TGU404010/12401523 UDI# (B)(4). TGU404010/13768677 UDI# (B)(4). TGU404010/14278707 UDI# (B)(4). ACCORDING TO THE GORE EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A BENTALL AND ENDOVASCULAR PROCEDURE FOR A TYPE B DISSECTION REPAIR USING GORE® ENDOPROSTHESES (UNKNOWN). THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT DEVELOPED A THORACOABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM WHEREBY CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE WERE IMPLANTED. REPORTEDLY, THE PRE-IMPLANT COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 70.1MM. IT WAS REPORTED THAT ON (B)(6) 2016, A TYPE I AND TYPE II ENDOLEAKS WITH AN ANEURYSM ENLARGEMENT WERE IDENTIFIED. ON (B)(6)2016 THE PATIENT UNDERWENT A PERIGRAFT ARTERIAL SAC EMBOLIZATION USING THROMBIN GEL FOAM SLUSH AS WELL AS ENDOVASCULAR COILS. ALSO, ON (B)(6) 2016, AN ENDOLEAK THROUGH THE VISCERAL PERISCOPE GUTTER WAS NOTED AND ON (B)(6) 2017, THE PATIENT UNDERWENT THE COIL EMBOLIZATION PROCEDURE OF THE GUTTER SPACE. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW UP SCANS SHOWED THAT THE DIAMETER CHANGED FROM 70MM ON (B)(6) 2016 TO 67MM ON (B)(6) 2017. THE PHYSICIAN IS MONITORING THE PATIENT AND PLANNING THE FOLLOW UP EXAM IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431448 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 13809990

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R