BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2973953 · Received February 14, 2013

    Report

    Report Number
    2017233-2013-00070
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    March 10, 2009
    Report Date
    January 30, 2013
    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

    ADDITIONAL DEVICE IMPLANTED ON (B)(6) 2009: TG3415/06490713. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE IN 2003, THIS PATIENT UNDERWENT A PROCEDURE USING A HANDMADE Z STENT GRAFT TO TREAT A THORACIC AORTIC ANEURYSM. AN ON UNKNOWN DATE IN 2009, A TYPE 3 ENDOLEAK FROM THE HANDMADE STENT GRAFT WAS OBSERVED. ON (B)(6) 2009, TWO GORE TAG THORACIC ENDOPROSTHESIS WERE USED TO REPAIR THE TYPE 3 ENDOLEAK AND IMPLANTED WITHIN THE HANDMADE STENT GRAFT. THE PATIENT DEVELOPED A CEREBRAL INFARCT POSTOPERATIVELY. THE PHYSICIAN TREATED A PATIENT WITH RADICUT. HOWEVER, THE PATIENT'S CONDITION DID NOT IMPROVE. ACCORDING TO THE PHYSICIAN, THE PATIENT'S AORTA HAD SEVERAL CLOTS AND THE LUMINAL SURFACE APPEARED TO BE "SHAGGY." ALSO, THE PHYSICIAN REPORTED THAT IT WAS DIFFICULT TO ADVANCE THE TAG DELIVERY CATHETER SMOOTHLY THROUGH THE HANDMADE STENT GRAFT. THE PHYSICIAN ATTRIBUTES THE CEREBRAL INFARCT TO SHOWER EMBOLI. THE PATIENT EXPIRED ON (B)(6) 2010 DUE TO MULTI ORGAN FAILURE. THE DEATH WAS NOT ATTRIBUTED TO THE DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66241 GORE TAG THORACIC ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 06561055

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| O| R