BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5584463 · Received April 18, 2016

    Report

    Report Number
    2017233-2016-00366
    Event Type
    Injury
    Date Received
    April 18, 2016
    Date of Event
    February 23, 2011
    Report Date
    March 22, 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

    CONCOMITANT MEDICAL PRODUCTS: (B)(6) 2011: TGT4010/8130691, TGT4010/7042172, PXC161200/8142333, PXA280300/8636170. 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) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A THORACIC AORTIC DISSECTION USING THREE GORE® TAG® THORACIC ENDOPROSTHESES (TGT3420/8467339, TGT4010/8130691, TGT4010/7042172) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT (PXA280300/8636170). A CONTRALATERAL LEG COMPONENT (PXC161200/8142333) WAS ALSO IMPLANTED IN THE INNOMINATE ARTERY TO MAINTAIN BLOOD FLOW. POST IMPLANTATION, THROMBOSIS FORMATION WAS OBSERVED. (IT IS UNKNOWN WHERE THE THROMBOSIS WAS FORMED.) NO TREATMENT WAS PERFORMED AND THE PATIENT WAS MONITORED. THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 75 MM. ON (B)(6) 2011, ANGIOPLASTY WAS PERFORMED, AND METALLIC STENT WAS IMPLANTED TO TREAT THE THROMBOSIS. ON THE SAME DAY, THE PATIENT PRESENTED WITH A MINOR SYMPTOM OF STROKE. ON (B)(6) 2011, RESOLUTIONS OF THE THROMBOSIS AND STROKE WAS CONFIRMED. A TYPE II ENDOLEAK (ORIGIN UNKNOWN) WAS IDENTIFIED. THE ANEURYSM DIAMETER MEASURED 75 MM. ON (B)(6) 2011, COIL EMBOLIZATION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. ON (B)(6) 2011, THE RESOLUTION OF THE TYPE II ENDOLEAK WAS CONFIRMED. THE ANEURYSM DIAMETER MEASURED 75 MM. ON (B)(6) 2012, THE ANEURYSM DIAMETER MEASURED 85 MM. IT IS UNKNOWN WHETHER THERE WAS AN ENDOLEAK. ON (B)(6) 2013, THE ANEURYSM DIAMETER MEASURED 88 MM. IT IS UNKNOWN WHETHER THERE WAS AN ENDOLEAK. ON (B)(6) 2014, THE ANEURYSM DIAMETER MEASURED 88 MM. IT IS UNKNOWN WHETHER THERE WAS AN ENDOLEAK. THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240331 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8467339

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R