BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1050237 · Received May 23, 2008

    Report

    Report Number
    2017233-2008-00293
    Event Type
    Injury
    Date Received
    May 23, 2008
    Report Date
    May 22, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    AS REPORTED, AT AN UNKNOWN DATE, THIS PATIENT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS AFTER SUSTAINING A GUNSHOT WOUND TO THE LEFT SHOULDER. COMPUTED TOMOGRAPHY REVEALED A PSEUDOANEURYSM AT THE SUPERIOR ASPECT OF THE AORTA. THE DEVICE WAS DEPLOYED ACROSS THE AORTIC DEFECT AND THE LEFT SUBCLAVIAN ARTERY. A FOLLOW UP CT REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PATIENT UNDERWENT A REINTERVENTION IN WHICH A SECOND TAG DEVICE WAS IMPLANTED, EXTENDING TO THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. FOLLOW-UP CT ANGIOGRAPHY BEFORE DISCHARGE AND AT 3 MONTHS DEMONSTRATED COMPLETE EXCLUSION OF THE PSEUDOANEURYSM. THE PATIENT REMAINED ASYMPTOMATIC AND 6 MONTH IMAGING REVEALED INFOLDING OF THE PROXIMAL STENT GRAFT. THE PATIENT UNDERWENT A REINTERVENTION IN WHICH THE TAG DEVICES WERE RE-EXPANDED USING A 32-MM CODA BALLOON. A PALMAZ STENT WAS DEPLOYED INTO THE PROXIMAL PORTION OF THE INFOLDED STENT GRAFT. THE STENT WAS POST-DILATED WITH THE 32 MM CODA BALLOON. FOLLOW UP CT ANGIOGRAMS BEFORE DISCHARGE AND AT 3 MONTHS DEMONSTRATED ADEQUATE EXPANSION OF THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES, INC WLG326

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention