BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4090863 · Received September 15, 2014

    Report

    Report Number
    2017233-2014-00472
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    June 28, 2011
    Report Date
    August 29, 2014
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A SELF-MADE BRANCHED STENT GRAFT IN AN OPEN THORACIC PROCEDURE (OPEN STENT-GRAFT TECHNIQUE) TO MAINTAIN BLOOD FLOW TO THE BRANCH ARTERIES OF THE AORTIC ARCH. ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC DISSECTION USING A GORE® TAG® THORACIC ENDOPROSTHESIS (TGT3420/7160426). THE PATIENT TOLERATED THE PROCEDURE, AND NO ENDOLEAK OR ADVERSE EVENTS OCCURRED TO THE PATIENT AFTER THE PROCEDURE. ON (B)(6) 2010, A FOLLOW-UP STUDY REVEALED NO ENDOLEAK AND ADVERSE EVENTS, AND THE ANEURYSM DIAMETER WAS 55MM. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED OF THE HOSPITAL. ON (B)(6) 2010, A SIX-MONTH FOLLOW-UP STUDY REVEALED NO ENDOLEAK AND ADVERSE EVENTS, AND THE ANEURYSM DIAMETER WAS 51MM. ON JUNE 28, 2011, A ONE-YEAR FOLLOW-UP STUDY REVEALED A DISTAL TYPE I ENDOLEAK WITH THE ANEURYSM DIAMETER OF 57MM. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL STENT GRAFT TO TREAT THE DISTAL TYPE I ENDOLEAK. AFTER THE REINTERVENTION, THE ENDOLEAK WAS RESOLVED. ON (B)(6) 2012, A TWO-YEAR FOLLOW-UP STUDY REVEALED NO ADVERSE EVENTS WITH ANEURYSM DIAMETER SHRINKING TO 53 MM. PER THE PHYSICIAN, AN AORTIC DISSECTION (EROSION) WAS FORMED DISTAL TO THE STENT GRAFT. THIS MAY HAVE CAUSED THE LACK OF SEALING TO THE AORTIC WALL AND THE DISTAL TYPE I ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568425 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7160426

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention