BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3082937 · Received April 23, 2013

    Report

    Report Number
    2017233-2013-00246
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    February 12, 2007
    Report Date
    March 26, 2013
    Manufacturer
    W.L. GORE & ASSOCAITES
    Product Code
    MIH
    PMA / PMN Number
    P0040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK AND REOPERATION.

    Description of Event or Problem · 1

    ON AN UNK DATE IN (B)(6) 2006, THE PT UNDERWENT A RIGHT COMMON CAROTID ARTERY TO LEFT COMMON CAROTID ARTERY BYPASS. ON AN UNK DATE IN (B)(6) 2006, THE PT UNDERWENT A LEFT COMMON CAROTID ARTERY TO LEFT SUBCLAVIAN ARTERY BYPASS. ON (B)(6) 2007, THE PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS. PT DIAGNOSIS AT THE TIME IS UNK. ON (B)(6) COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2007, THE PT WAS IMPLANTED WITH AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS TO TREAT THE TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED, AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175556 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCAITES 04546556

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R