IN 2008, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER A MOTOR VEHICLE ACCIDENT. COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED A RIGHT SIDE AORTIC ARCH WITH APPROXIMATELY 5 CM PSEUDOANEURYSM IN THE VICINITY OF THE LEFT SUBCLAVIAN. A GORE TAG THORACIC ENDOPROSTHESIS GRAFT WAS DEPLOYED TO EXCLUDE THE PSEUDOANEURYSM. THERE WAS NO EVIDENCE OF ENDOLEAK AND THE PATIENT TOLERATED THE PROCEDURE. THE NEXT DAY, A COMPUTED TOMOGRAPHY ANGIOGRAPHY NOTED A PROXIMAL TYPE I ENDOLEAK. ONE DAY LATER, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION TO REPAIR THE TYPE I ENDOLEAK. INFOLDING OF THE GORE TAG THORACIC ENDOPROSTHESIS WAS DISCOVERED AND REPAIRED WITH A SECOND GORE TAG THORACIC ENDOPROSTHESIS INSERTED INTO THE FIRST ONE. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.
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Patient 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, STRICT ADHERENCE TO THE GORE TAG THORACIC ENDOPROSTHESIS IFU SIZING GUIDE IS REQUIRED WHEN SELECTING THE APPROPRIATE DEVICE SIZE. THE GORE TAG THORACIC ENDOPROSTHESIS IS DESIGNED TO BE OVERSIZED FROM 7 TO 18%. APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING, OR COMPRESSION.