BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAG

    MDR report key: 1031834 · Received April 18, 2008

    Report

    Report Number
    1031834
    Event Type
    Death
    Date Received
    April 18, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 17, 2008
    Manufacturer
    WL GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A TAG STENT GRAFT REPAIR IN 2007 FOR A TRAUMATIC THORACIC AORTA TRANSECTION. PROCEDURE WAS PERFORMED WITHOUT COMPLICATIONS. UPON FOLLOW-UP WITH VASCULAR SURGERY, PT WAS FOUND TO HAVE SOME NARROWING WITHIN HIS PROXIMAL PORTION OF THE STENT GRAFT. THIS WAS REPAIRED WITH AN ENDOLUMINAL STENT IN 2008. HIS CT SCAN AT ONE MONTH REVEALED THAT HIS STENT WAS OPENED WITHOUT ANY NARROWING. PT PRESENTED TO THE ED ABOUT 3 MONTHS LATER WITH SHORTNESS OF BREATH AND COMPLETE CARDIOPULMONARY FAILURE. ON FURTHER EVALUATION WITH A CT SCAN DEMONSTRATED TOTAL COLLAPSE OF THE PROXIMAL ASPECT OF THE THORACIC STENT GRAFT. FOUR DAYS LATER, PT UNDERWENT A PALMAZ STENTING OF THE TAG STENT GRAFT FOR TOTAL COLLAPSE OF THE STENT. UNFORTUNATELY PT DEVELOPED TACHYARRHYTHMIAS AND CODED, PER ACLS PROTOCOL, AND ULTIMATELY DIED LATER IN THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAG THORACIC STENT GRAFT MIH WL GORE & ASSOCIATES, INC 04297994

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death