BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4090889 · Received September 15, 2014

    Report

    Report Number
    2017233-2014-00473
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    March 5, 2012
    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) 2009, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ANEURYSM OF A DESCENDING THORACIC AORTA USING TWO GORE® TAG® THORACIC ENDOPROSTHESES. SEVERE CALCIFICATION WAS REVEALED IN THE FEMORAL AND ILIAC ARTERIES, AND THE PHYSICIAN PREPARED A CONDUIT IN THE LEFT COMMON ILIAC ARTERY. AN INTRODUCER SHEATH WAS THEN INSERTED THROUGH THE CONDUIT AND THE STENT GRAFTS (TG2610/06839535, TG2810/06475154) WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE AND NO ENDOLEAK OR ADVERSE EVENTS OCCURRED TO THE PATIENT AFTER THE PROCEDURE. FOLLOW-UP STUDIES REVEALED THAT THE PATIENT DID NOT DEVELOP ANY ADVERSE EVENT. ON (B)(6) 2012, A COMPUTED TOMOGRAPHY (CT) PERFORMED IN ANOTHER HOSPITAL REVEALED A NEW AORTIC ANEURYSM IN THE DISTAL PORTION OF THE AORTIC ARCH. ON (B)(6) 2012, THE PATIENT UNDERWENT ANOTHER ENDOVASCULAR REPAIR OF THE AORTIC ARCH ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS. PRIOR TO IMPLANTATION OF A STENT GRAFT, THE PHYSICIAN SUTURED A GRAFT IN THE ASCENDING AORTA IN AN OPEN CHEST PROCEDURE, AND A DEBRANCHING TO ALL THE BRANCH VESSELS IN THE AORTIC ARCH WAS PERFORMED (COMPLETE DEBRANCHING PROCEDURE). THE PHYSICIAN THEN ADVANCED A DELIVERY CATHETER THROUGH THE SUTURED GRAFT AND IMPLANTED THE STENT GRAFT (TGT3415/9737554) IN AN ASCENDING AORTIC APPROACH. AN INTRA-PROCEDURE TEST REVEALED A PROXIMAL TYPE I ENDOLEAK AND A TYPE II ENDOLEAK, AND THE PHYSICIAN PERFORMED A TOUCH-UP BALLOONING TO THE PROXIMAL END OF THE STENT GRAFT. THE ENDOLEAKS WERE RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE. ON THE SAME DAY, THE PATIENT DEVELOPED A CEREBRAL INFARCTION, AND MEDICATIONS WERE ADMINISTERED TO TREAT THE CEREBRAL INFARCTION. ON (B)(6) 2012, A FOLLOW-UP STUDY REVEALED THAT ANEURYSM WAS EXCLUDED, BUT THE CEREBRAL INFARCTION HAD STILL PERSISTED. PER THE PHYSICIAN, THE COMPLETE-DEBRANCHING PROCEDURE MIGHT HAVE BEEN ATTRIBUTED TO THE CEREBRAL INFARCTION, BUT IT IS JUST ONE POSSIBILITY, AND THE CAUSE IS UNKNOWN. ALSO, THE PATIENT¿S CONDITION AFTER THE FOLLOW-UP STUDY IS NOT KNOWN, EITHER. PER THE CASE REPORTS, THE LOCATION OF NEW AORTIC ANEURYSM WAS DIFFERENT FROM THE ONE TO WHICH THE INITIAL PROCEDURE WAS PERFORMED. THE NEW ANEURYSM IS NOT RELATED TO THE STENT GRAFTS THAT WERE INITIALLY IMPLANTED, EITHER. THEREFORE, THE INFORMATION REGARDING THE ENDOVASCULAR TREATMENT OF THE NEW AORTIC ANEURYSM ONLY WILL BE THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568903 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9737554

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R| S