BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2234010 · Received August 31, 2011

    Report

    Report Number
    2017233-2011-00450
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 31, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULT: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. PLEASE NOTE ADD'L DEVICES IMPLANTED: (B)(4)/9125535, (B)(4)/8178348, (B)(4)/8917443, (B)(4)/8945550, (B)(4)/9125536 AND (B)(4)/06675626.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT A COMPLETE OPEN ABDOMINAL DEBRANCHING PROCEDURE WITH BYPASS FROM THE LEFT COMMON ILIAC ARTERY TO THE CELIAC, SMA, RIGHT RENAL AND LEFT RENAL ARTERIES. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2011, THE PT WAS TREATED WITH EIGHT GORE TAG ENDOPROSTHESES FOR A LARGE THORACOABDOMINAL ANEURYSM (MEASUREMENTS NOT AVAILABLE). THE ENDOGRAFT SYSTEM WAS LANDED FROM THE LEFT SUBCLAVIAN TO APPROX 4 CM ABOVE THE AORTIC BIFURCATION. A TYPE II ENDOLEAK WAS SUSPECTED BETWEEN THE THIRD AND FOURTH GORE TAG ENDOPROSTHESIS AND AN ADD'L GORE TAG ENDOPROSTHESES WAS IMPLANTED TO BRIDGE THE DEVICES. ON (B)(6) 2011, A DISTAL TYPE I ENDOLEAK WAS VISIBLE ON CT. A DISTAL TYPE I ENDOLEAK WAS ALSO NOTED AT THE ONE MONTH F/U (DATE UNK). ON (B)(6) 2011, THE PT UNDERWENT AN INTERVENTION WHERE AN ADD'L GORE TAG ENDOPROSTHESIS WAS IMPLANTED. THE TYPE I ENDOLEAK WAS RESOLVED. A SMALL TYPE II ENDOLEAK WAS NOTED. THE PT 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 8945551

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R SENOKOT| TRAMADOL| SIMVASTATIN