BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2122973 · Received June 9, 2011

    Report

    Report Number
    2017233-2011-00272
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 8, 2011
    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

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT ETIOLOGIES: ACUTE AND CHRONIC DISSECTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC TYPE B DISSECTION. IN (B)(6) 2011 (EXACT DATE UNKNOWN), A FOLLOW UP COMPUTED TOMOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011, THE PHYSICIAN PERFORMED AN AXILLARY-AXILLARY BYPASS PROCEDURE USING A VASCULAR GRAFT. AFTER THE BYPASS PROCEDURE, A GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED JUST BELOW THE CAROTID ARTERY TO TREAT THE PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

    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 WLG426 8306074

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R