BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2142910 · Received June 22, 2011

    Report

    Report Number
    2017233-2011-00303
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    March 26, 2010
    Report Date
    June 21, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. AS STATED IN THE GORE TAG THORACIC ENDOPROSTHESIS IFU, THE GORE TAG THORACIC ENDOPROSTHESIS IS INTENDED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PTS WHO HAVE APPROPRIATE ANATOMY. THE SAFETY AND EFFECTIVENESS OF THE TAG DEVICE HAVE NOT BEEN EVALUATED IN PTS WITH ACUTE AND CHRONIC DISSECTIONS. COMPLICATIONS ASSOCIATED WITH THE USE OF THE TAG DEVICE MAY INCLUDE, BUT ARE NOT LIMITED TO, SURGICAL CONVERSION. ADD'L GORE TAG DEVICES RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESES TO TREAT CHRONIC DISSECTION OF DISTAL ARCH WITH DESCENDING THORACIC AORTIC ANEURYSM. ON (B)(6), 2010, THE PT WAS CONVERTED TO OPEN SURGICAL REPAIR, AND THE GORE TAG DEVICES WERE EXPLANTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG326 06795528

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R CHANTIX| AMLODIPINE| SIMVASTATIN| HYDROCHLOROTHIAZIDE| DIAZEPAM| PRILOSEC| METOPROLOL