BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1020580 · Received March 28, 2008

    Report

    Report Number
    2017233-2008-00089
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 27, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2008, A PT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A DESCENDING THORACIC AORTIC ANEURYSM. FOURTEEN DAYS LATER, THE PT WAS SEEN FOR BACK PAIN. A CT SCAN REVEALED THAT THE DEVICE WAS COMPRESSED. THE DEVICE WAS IMPLANTED TOO FAR DISTALLY, WHICH DID NOT ALLOW FOR PROXIMAL AORTIC WALL APPOSITION, CAUSING DEVICE COMPRESSION. TWO DAYS LATER, A REINTERVENTION OCCURRED. A SECOND GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED AND RESOLVED COMPRESSION OF THE DEVICE. PT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES,INC WLG326 03682040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention