BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5523117 · Received March 24, 2016

    Report

    Report Number
    2017233-2016-00280
    Event Type
    Injury
    Date Received
    March 24, 2016
    Date of Event
    November 25, 2010
    Report Date
    March 9, 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. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A DISSECTED THORACIC AORTIC ANEURYSM USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT2815/8383133, TGT3420/8200699). NO ISSUES WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. A TYPE II ENDOLEAK OF UNKNOWN ORIGIN WAS REPORTED. THE DIAMETER OF THE ANEURYSM WAS 40 MM. ON (B)(6) 2011, SIX MONTH FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM ENLARGED TO 47 MM. NON-CONTRAST CT WAS PERFORMED, SO IT WAS UNKNOWN IF ENDOLEAK WAS PRESENT. ON (B)(6) 2011, ONE YEAR FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM FURTHER ENLARGED TO 51 MM. THE TYPE II ENDOLEAK REPORTEDLY PERSISTED. ON (B)(6) 2011, A COIL EMBOLIZATION PROCEDURE WAS PERFORMED TO REPAIR THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. DURING SUBSEQUENT FOLLOW-UPS, NON-CONTRAST CT WAS PERFORMED, SO IT WAS UNKNOWN IF ENDOLEAK WAS PRESENT. IT WAS REPORTED THAT THE DIAMETER OF THE ANEURYSM MEASURED 46 MM. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179185 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8383133

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R TGT3420/8200699