BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2832968 · Received November 5, 2012

    Report

    Report Number
    2017233-2012-00745
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    December 14, 2010
    Report Date
    October 12, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS; THE CAUSE OF THE INTERVENTION ON (B)(6) 2010 IS UNK.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A CHRONIC TYPE B DISSECTION. INTERNATIONAL COVERAGE AND BYPASS OF THE LEFT COMMON CAROTID LEFT SUBCLAVIAN ARTERIES WAS ALSO PERFORMED. ON (B)(6) 2010, AN ADD'L PROCEDURE WAS PERFORMED WHEREBY AN ADD'L GORE TAG DEVICE WAS IMPLANTED.

    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 8330214

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R PEPCID| COLASE| PT MEDICATIONS INCLUDE OXYCODONE| (B)(4)| (B)(4)| ASPIRIN| CEFAZOLIN| HYDROMORPHONE