BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1050328 · Received May 22, 2008

    Report

    Report Number
    2017233-2008-00286
    Event Type
    Injury
    Date Received
    May 22, 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

    AT AN UNK DATE, THIS PT INVOLVED IN A MOTOR VEHICLE ACCIDENT PRESENTED WITH A CONTAINED THORACIC RUPTURE AND WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS ACROSS THE AORTIC RUPTURE AND LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS POSTDILATED WITH THE GORE TRI LOBE BALLOON CATHETER. COMPLETION AORTOGRAPHY DEMONSTRATED BIRD-BEAKING OF THE ENDOGRAFT FROM THE INFERIOR SURFACE OF THE AORTIC ARCH. HOWEVER, BECAUSE THE PSEUDOANEURYSM HAD BEEN SUCCESSFULLY EXCLUDED WITHOUT EVIDENCE OF SIGNIFICANT OBSTRUCTION OF FLOW, NO FURTHER INTERVENTION WAS UNDERTAKEN. A FOLLOW-UP CT DEMONSTRATED INFOLDING OF THE ENTIRE ENDOGRAFT AND REPERFUSION OF THE PSEUDOANEURYSM. THE PT REMAINED ASYMPTOMATIC RELATIVE TO THE AORTIC INJURY AND ENDOGRAFT INFOLDING. AT AN UNK DATE THE DEVICES WERE EXPLANTED AND THE PT UNDERWENT OPEN SURGICAL REPAIR UNDER HYPOTHERMIC CIRCULATORY ARREST WITH USE OF A 22-MM VASCUTEK GRAFT. THE PT WAS DISCHARGED HOME.

    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 42 YR Required Intervention