BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4858287 · Received June 21, 2015

    Report

    Report Number
    2017233-2015-00374
    Event Type
    Injury
    Date Received
    June 21, 2015
    Date of Event
    June 29, 2011
    Report Date
    May 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. 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 (B)(6) 2010, THE PATIENT UNDERWENT AORTIC ARCH REPLACEMENT USING A GRAFT. ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3720/8317587 AND TGT4015/8233020). TWO STENT GRAFTS WERE DEPLOYED FROM THE DISTAL END OF THE EXISTING GRAFT USING AN ELEPHANT-TRUNK APPROACH. THE PROCEDURE WAS CONCLUDED WITHOUT ENDOLEAKS PRESENT. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED OF THE HOSPITAL. ANEURYSM DIAMETER WAS 68MM, AND NO ENDOLEAKS HAD BEEN PRESENT. ON (B)(6) 2011, IN SIX-MONTH FOLLOW-UP STUDY, A TYPE II ENDOLEAK HAD BEEN REVEALED. ANEURYSM DIAMETER WAS 68MM. ON (B)(6) 2011, IN ONE-YEAR FOLLOW-UP STUDY, THE TYPE II HAD PERSISTED. ANEURYSM DIAMETER HAD REMAINED UNCHANGED. A WAIT-AND-WATCH APPROACH WAS TAKEN TO THE ENDOLEAK. ON (B)(6) 2012, IN TWO-YEAR FOLLOW-UP STUDY, ANEURYSM DIAMETER HAD ENLARGED TO 70MM WITH PERSISTENT TYPE II ENDOLEAK. REINTERVENTION WAS NOT PERFORMED. ON (B)(6) 2013, IN THREE-YEAR FOLLOW-UP STUDY, ANEURYSM DIAMETER HAD STILL ENLARGED TO 77MM WITH THE PERSISTENT TYPE II ENDOLEAK. A WAIT-AND-WATCH APPROACH HAD BEEN CONTINUED TO THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401998 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8317587

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization TGT4015/8233020