BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5246515 · Received November 24, 2015

    Report

    Report Number
    2017233-2015-00834
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    December 11, 2010
    Report Date
    October 26, 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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE REVIEW OF THE STERILIZATION 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 AN UNKNOWN DATE, THIS PATIENT UNDERWENT TOTAL AORTIC ARCH REPLACEMENT FOR AORTIC ARCH ANEURYSM USING A VASCULAR GRAFT (MANUFACTURER UNKNOWN). ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING A THREE GORE TAG THORACIC ENDOPROSTHESES (TGT4020/8206545, TGT4020/8325112, AND TGT4015/8163383). ONE OF GORE TAG THORACIC ENDOPROSTHESES WAS IMPLANTED DISTALLY INSIDE THE PREVIOUSLY IMPLANTED VASCULAR GRAFT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE ANEURYSM DIAMETER MEASUREMENT AT THE TIME OF DISCHARGE WAS 77 MM. A TYPE II ENDOLEAK WAS ALSO IDENTIFIED AT THE TIME OF DISCHARGE, BUT THE PHYSICIAN DECIDED TO TAKE A WAIT AND SEE APPROACH. ON (B)(6) 2012, AN INFECTION IN THE VASCULAR GRAFT WAS FOUND. IT WAS UNKNOWN IF THE INFECTION HAD SPREAD PAST THE VASCULAR GRAFT. THE CAUSE OF THE INFECTION WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT UNDERWENT A COURSE OF ANTIBIOTICS. THE DEVICES WERE STILL IMPLANTED. ON (B)(6) 2012, THE TYPE II ENDOLEAK WAS NO LONGER SEEN ON IMAGING. THE ANEURYSM DIAMETER MEASURED 85 MM. ON (B)(6) 2013, THE ANEURYSM DIAMETER MEASURED 76 MM AND THE INFECTION WAS RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777090 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8206545

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other TGT4020/8325112, TGT4015/8163383