BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5627647 · Received May 3, 2016

    Report

    Report Number
    2017233-2016-00440
    Event Type
    Injury
    Date Received
    May 3, 2016
    Date of Event
    July 9, 2013
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS 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 (B)(6) 2009, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (DISTAL: TG2610/06152707, PROXIMAL: TG3115/7001108). DURING THE PROCEDURE, THE LEFT SUBCLAVIAN ARTERY WAS COIL EMBOLIZED. THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 60 MM. ON (B)(6) 2009, THE ANEURYSM DIAMETER MEASURED 58 MM. NO ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2010, THE ANEURYSM DIAMETER MEASURED 57 MM. NO ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2011, THE ANEURYSM DIAMETER MEASURED 36 MM. NO ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2012, THE ANEURYSM DIAMETER MEASURED 36 MM. NO ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2012, A NEW THORACOABDOMINAL ANEURYSM WAS IDENTIFIED. ON (B)(6) 2012, A BYPASS SURGERY WAS PERFORMED ON THE SMA AND BOTH RENAL ARTERIES. ON (B)(6) 2012, A NON-GORE STENT GRAFT WAS IMPLANTED TO REPAIR THE NEW ANEURYSM. ON (B)(6) 2013, A TYPE II ENDOLEAK FROM THE LEFT SUBCLAVIAN ARTERY WAS IDENTIFIED. ON (B)(6) 2013, A REINTERVENTION WAS PERFORMED TO TREAT A TYPE II ENDOLEAK WITH COIL. HOWEVER, CANNULATION OF THE LEFT SUBCLAVIAN ARTERY WAS UNSUCCESSFUL. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283630 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7001108

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R