BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4251191 · Received November 14, 2014

    Report

    Report Number
    2017233-2014-00602
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    March 16, 2010
    Report Date
    November 6, 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

    RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSION: THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATE THAT POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS INCLUDE ENDOLEAK AND REOPERATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT THE FIRST STAGE OF THE ENDOVASCULAR REPAIR OF A THORACO-ABDOMINAL AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS (TG2815/06629441). IT WAS REPORTED THAT DURING THIS PROCEDURE, THE RIGHT EXTERNAL ILIAC ARTERY WAS REPLACED WITH A VASCULAR GRAFT. AND A BYPASS FROM THE LEFT COMMON ILIAC ARTERY TO THE SUPERIOR MESENTERIC ARTERY AND THE SPLENIC ARTERY WAS PERFORMED. THE PROCEDURE CONCLUDED WITHOUT ISSUES. ON (B)(6) 2010, THE PATIENT UNDERWENT THE SECOND STAGE OF THE ENDOVASCULAR REPAIR OF A THORACO-ABDOMINAL AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TG2610/06616496, TG3115/7244597). DURING THE PROCEDURE, THE CELIAC ARTERY WAS COIL EMBOLIZED. THE FINAL ANGIOGRAPHY SHOWED A TYPE II ENDOLEAK AND A TYPE III ENDOLEAK. ON (B)(6) 2010, AT 1-MONTH FOLLOW-UP EXAMINATION, THE PERSISTENT MINOR TYPE II AND TYPE III ENDOLEAKS WERE OBSERVED. THE ANEURYSM DIAMETER MEASURED 60MM. ON (B)(6) 2010, TWO GORE® TAG® THORACIC ENDOPROSTHESES�@(TG2815/06822589, TG3115/7046289) WERE IMPLANTED IN DISTALLY TO REPAIR THE TYPE III ENDOLEAKS, AND RE-COIL EMBOLIZATION OF THE CELIAC ARTERY WAS PERFORMED TO REPAIR THE TYPE II ENDOLEAK. ON (B)(6) 2010, AT 6-MONTH FOLLOW-UP EXAMINATION, THE RESOLUTION OF THE ENDOLEAKS WAS CONFIRMED. THE ANEURYSM DIAMETER WAS 68MM. THE PATIENT DID NOT SHOW FOR A ONE-YEAR FOLLOW-UP EXAMINATION. ON (B)(6) 2012, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED AT TWO-YEAR FOLLOW-UP EXAMINATION. THE ANEURYSM DIAMETER MEASURED 85MM. ON (B)(6) 2012, THE PATIENT UNDERWENT AN OPEN REPAIR WITH A VASCULAR GRAFT TO REPAIR THE TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2012 THE PATIENT EXPIRED DUE TO HEART FAILURE. PATIENT WEIGHT: 67KG PATIENT DOB: (B)(6) 1959 PATIENT'S MEDICAL HISTORY: RENAL DISEASE, HYPERTENSION, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

    Description of Event or Problem · 1

    ON (B)(4) 2010, THE PATIENT UNDERWENT THE FIRST STAGE OF THE ENDOVASCULAR REPAIR OF A THORACO-ABDOMINAL AORTIC ANEURYSM USING A GORE TAG THORACIC ENDOPROSTHESIS (TG2815/06629441). IT WAS REPORTED THAT DURING THIS PROCEDURE, THE RIGHT EXTERNAL ILIAC ARTERY WAS REPLACED WITH A VASCULAR GRAFT. AND A BYPASS FROM THE LEFT COMMON ILIAC ARTERY TO THE SUPERIOR MESENTERIC ARTERY AND THE SPLENIC ARTERY WAS PERFORMED. THE PROCEDURE CONCLUDED WITHOUT ISSUES. ON (B)(4) 2010, THE PATIENT UNDERWENT THE SECOND STAGE OF THE ENDOVASCULAR REPAIR OF A THORACO-ABDOMINAL AORTIC ANEURYSM USING TWO GORE TAG THORACIC ENDOPROSTHESES (TG2610/06616496, IMPLANTED DISTALLY, AND TG3115/7244597 IMPLANTED BETWEEN THE INITIALLY IMPLANTED TG2815 DEVICE AND THE TG2610 DEVICE). DURING THE PROCEDURE, THE CELIAC ARTERY WAS COIL EMBOLIZED. THE FINAL ANGIOGRAPHY SHOWED A TYPE II ENDOLEAK SUSPECTED TO ORIGINATE FROM THE CELIAC ARTERY, AND A TYPE III ENDOLEAK. ON (B)(4) 2010, AT 1-MONTH FOLLOW-UP EXAMINATION, THE PERSISTENT MINOR TYPE II, AND TYPE III ENDOLEAKS WERE OBSERVED. THE ANEURYSM DIAMETER MEASURED 60MM. ON (B)(4) 2010, TWO GORE TAG THORACIC ENDOPROSTHESES, (TG2815/06822589, WHICH WAS IMPLANTED PROXIMALLY, AND TG3115/7046289) WERE IMPLANTED IN DISTALLY TO REPAIR THE TYPE III ENDOLEAKS, AND RE-COIL EMBOLIZATION OF THE CELIAC ARTERY WAS PERFORMED TO REPAIR THE TYPE II ENDOLEAK. THE DIAMETER OF THE ANEURYSM AT THIS POINT IS UNKNOWN. ON (B)(4) 2010, AT 6-MONTH FOLLOW-UP EXAMINATION, THE RESOLUTION OF THE ENDOLEAKS WAS CONFIRMED. THE ANEURYSM DIAMETER WAS 68MM. THE PATIENT DID NOT SHOW FOR A ONE-YEAR FOLLOW-UP EXAMINATION. ON (B)(4) 2012, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED AT TWO-YEAR FOLLOW-UP EXAMINATION. THE CAUSE OF THIS ENDOLEAK IS UNKNOWN. THE ANEURYSM DIAMETER MEASURED 85MM. ON (B)(4) 2012, THE PATIENT UNDERWENT AN OPEN REPAIR WITH A VASCULAR GRAFT TO REPAIR THE TYPE I ENDOLEAK. ALL DEVICES WERE EXPLANTED DURING THIS PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE, HOWEVER DEVELOPED RESPIRATORY FAILURE. ON (B)(4) 2012, THE PATIENT EXPIRED DUE TO HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736971 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06629441

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R