BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4803858 · Received May 28, 2015

    Report

    Report Number
    2017233-2015-00322
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    September 2, 2010
    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 ENDOVASCULAR REPAIR OF A THORACIC AORTIC DISSECTION USING GORE® TAG® THORACIC ENDOPROSTHESIS (TGT2815/8020044). PRIOR TO IMPLANTATION OF THE STENT GRAFT, AXILLO-AXILLARY BYPASS PROCEDURE WAS PERFORMED TO MAINTAIN BLOOD FLOW TO THE LEFT SUBCLAVIAN ARTERY (LSA), AND THE TGT2815 WAS DEPLOYED JUST BELOW THE LSA. ADDITIONALLY, A SELF-MADE, FENESTRATED STENT GRAFT WAS IMPLANTED FROM THE BRACHIOCEPHALIC ARTERY, PROXIMAL TO THE TGT2815. INTRA-PROCEDURE IMAGING REVEALED A TYPE II ENDOLEAK, BUT THE PROCEDURE WAS CONCLUDED WITH A WAIT-AND-WATCH APPROACH TAKEN TO THE ENDOLEAK. ON (B)(6) 2010, A COIL-EMBOLIZATION PROCEDURE WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED OF THE HOSPITAL WITH TYPE II ENDOLEAK BEING RESOLVED. ANEURYSM DIAMETER WAS 58MM. ON (B)(6) 2011, IN SIX-MONTH FOLLOW-UP STUDY, A PROXIMAL TYPE I ENDOLEAK WAS REVEALED. ANEURYSM DIAMETER WAS 60MM. 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 65MM WITH THE PROXIMAL TYPE I ENDOLEAK PERSISTING. ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A NON-GORE STENT GRAFT TO TREAT THE PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2013, THE PROXIMAL TYPE I ENDOLEAK HAD STILL PERSISTED AFTER THE REINTERVENTION, AND THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL GORE® TAG® THORACIC ENDOPROSTHESIS TO TREAT THE ENDOLEAK. ON (B)(6) 2013, IN THREE-YEAR FOLLOW-UP STUDY, IT WAS REVEALED THAT THE ENDOLEAK HAD BEEN RESOLVED. ANEURYSM DIAMETER WAS 65MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346624 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8020044

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R