The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® tri-lobe balloon catheter instructions for use states that adverse events which may require intervention include, but are not limited to: trauma to the vessel wall, including dissection, perforation or rupture.
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On (b)(6) 2018, the patient underwent surgical de-branching of the left subclavian artery, the left common carotid artery and the innominate artery prior to endovascular repair of a thoracic aortic aneurysm.On (b)(6) 2018, the patient underwent endovascular repair of a thoracic aortic aneurysm.Two conformable gore® tag® thoracic endoprostheses (proximal: tgu454520j/(b)(4), distal: tgu373715j/(b)(4)) were successfully deployed although a bird beak configuration was observed in the proximal part of tgu454520j/(b)(4).The procedure was completed without further treatment since no endoleak and no vessel rupture/dissection was observed.The patient tolerated the procedure.On (b)(6) 2018, a follow-up computed tomography (ct) revealed a retrograde thoracic aortic dissection originating around the proximal end of tgu454520j/(b)(4) device and leading to a coronary artery.An open surgery was performed to treat the dissection.The clinical specialist visited the medical facility on (b)(6) 2018, and following information was provided by the medical facility.Excessive ballooning was performed during the procedure and the tip of the balloon was thought to be positioned outside of the proximal part of conformable gore® tag® thoracic endoprostheses.Therefore, the dissection was caused by the balloon instead of the conformable gore® tag® thoracic endoprostheses, although the dissection was not noticed during the procedure.After the dissection was observed with the follow up ct, the patient was transferred to another medical facility.Therefore, it is unknown what kind of treatment was performed for the dissection.It is also unknown the current patient condition.
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