BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2211375 · Received August 8, 2011

    Report

    Report Number
    2017233-2011-00404
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    May 31, 2011
    Report Date
    August 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

    PLEASE NOTE ADD'L DEVICE RELATED TO THIS EVENT: TGT3415/8876354. A REVIEW OF THE MFG RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. A REVIEW OF THE MFG RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECS. THE GORE TAG THORACIC INSTRUCTIONS FOR USE IFU STATES: "THE GORE TAG THORACIC ENDOPROSTHESIS PROVIDES ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA (DTA)". ADDITIONALLY, THE IFU STATES UNDER POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS: COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIS ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO: NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE, PARAPLEGIA, PARAPARESIS).

    Description of Event or Problem · 1

    (B)(6), 2011, THE PT UNDERWENT TREATMENT FOR A DISTAL ARCH, THORACIC AORTIC ANEURYSM. PRIOR TO IMPLANT, BYPASS SURGERY WAS PERFORMED, AND DEBRANCHING FROM THE RIGHT SUBCLAVIAN ARTERY TO LEFT SUBCLAVIAN ARTERY WAS PERFORMED. TWO GORE TAG THORACIC ENDOPROSTHESIS WERE IMPLANTED WITH INTENTIONAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY AND LEFT VERTEBRAL ARTERY (VA). THE PROCEDURE CONCLUDED WITH COIL EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY. FINAL ANGIOGRAM INDICATED NO ENDOLEAK. LATER THIS SAME DAY, THE PT PRESENTED WITH INCOMPLETE PARALYSIS OF THE LEFT LIMB. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH REVEALED A DECREASED FLOW TO THE LEFT VA. THE PT WAS ADMINISTERED HEPARIN AND LOW MOLECULAR WEIGHT DEXTRAN. THE PHYSICIAN IDENTIFIED NO CAUSE FOR THE PARALYSIS.

    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 8949076

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| S TGT3415/8876354