BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4090833 · Received September 15, 2014

    Report

    Report Number
    2017233-2014-00471
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 22, 2014
    Report Date
    January 22, 2015
    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

    CORRECTED EVENT DESCRIPTION REGARDING THE INFORMATION ON 8/18/2014. ADDED REINTERVENTION TO TREAT THE PSEUDO-ANEURYSM AND THE PATIENT'S CONDITION AFTER THE REINTERVENTION.

    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) 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS. THE PHYSICIAN IMPLANTED A STENT GRAFT (TGT3410/8530778) IN THE POSITION WHERE THE LEFT SUBCLAVIAN ARTERY WAS INTENTIONALLY COVERED (IN ZONE 2). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2014, A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) DID NOT SHOW A PSEUDO-ANEURYSM. ON (B)(6) 2014, ANOTHER FOLLOW-UP CT REVEALED A PSEUDO-ANEURYSM. ON (B)(6) 2014, A FOLLOW-UP CT ANGIOGRAPHY CONFIRMED THAT THE PSEUDO-ANEURYSM WAS FORMED IN THE AREA PROXIMAL TO THE FLARE STRUCTURE OF THE STENT GRAFT. THE PHYSICIAN TAKES A WAIT-AND-WATCH APPROACH TO THE PSEUDO-ANEURYSM NOW BUT IS PLANNING THAT ADDITIONAL STENT GRAFT WITH FENESTRATION IS IMPLANTED OR THAT AN OPEN THORACIC PROCEDURE IS PERFORMED TO TREAT THE PSEUDO-ANEURYSM, DEPENDING ON THE TEST RESULTS. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, AND THE CURRENT PATIENT¿S CONDITION IS UNKNOWN. PER THE PHYSICIAN, THE FLARE STRUCTURE OF THE STENT GRAFT HAS HIT THE VESSEL WALL FOR A LONG PERIOD OF TIME, WHICH MAY HAVE BEEN ATTRIBUTED TO THE PSEUDO-ANEURYSM FORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A GORE TAG THORACIC ENDOPROSTHESIS (TGT3410/8530778). THE PHYSICIAN IMPLANTED A STENT GRAFT IN THE POSITION WHERE THE LEFT SUBCLAVIAN ARTERY WAS INTENTIONALLY COVERED (IN ZONE 2). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2014, A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) DID NOT SHOW A PSEUDO-ANEURYSM. ON (B)(6) 2014, ANOTHER FOLLOW-UP CT REVEALED A PSEUDO-ANEURYSM HAD BEEN FORMED IN THE AREA PROXIMAL TO THE FLARE STRUCTURE OF THE STENT GRAFT. ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A NON-GORE FENESTRATED STENT GRAFT TO TREAT THE PSEUDO-ANEURYSM. ADDITIONALLY, A BYPASS PROCEDURE WAS PERFORMED FROM THE RIGHT COMMON CAROTID ARTERY TO THE LEFT COMMON CAROTID ARTERY TO MAINTAIN BLOOD FLOW TO THOSE ARTERIES. ON (B)(6) 2014, THE PATIENT HAD BEEN DOING WELL WITH THE PSEUDO-ANEURYSM TREATED. IT WAS REPORTED THAT THE FLARE STRUCTURE OF THE STENT GRAFT HAS HIT THE VESSEL WALL FOR A LONG PERIOD OF TIME, WHICH MAY HAVE BEEN ATTRIBUTED TO THE FORMATION OF PSEUDO-ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568384 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8530778

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R