Description of Event or Problem · 1
THE FOLLOWING IS THE DESCRIPTION OF THE EVENT REPORTED BY (B)(6) TO BOLTON MEDICAL, INC. WITH REGARD TO 2247858-2014-00009. CASE REPORT FROM (B)(6) REPORTED AS: RELAY (40-195) WAS INSERTED IN THE DISTAL SIDE BY RIGHT FEMORAL ARTERY ACCESS. ADVANCED THE INNER SHEATH IN THE POSITION #1. CHECKED THAT THE DEPLOYMENT GRIP PASSED HANDLE BODY MARK. THE DISTANCE BETWEEN THE DISTAL MARKER OF THE GRAFT AND THE TIP OF OUTER SHEATH WAS LITTLE. ALIGNED THE POSITION INTO UPPER SIDE OF ANEURYSM AS PLANNED. IN THE POSITION #2, STARTED PULLING THE INNER SHEATH. AFTER DEPLOYING THE INNER SHEATH FOR 2 -3 BARE STENT LONG, THE DOCTOR PUSHED THE BLACK STATIONARY GRIP UP WHILE PULLING THE GRAY DEPLOYMENT GRIP TO PUSH THE STENT GRAFT INTO THE ANEURYSM ARCH FOR TIGHT ATTACHMENT. AT THIS MOMENT, THE STENT WAS FLUOROSCOPICALLY CONFIRMED TO BE SLIGHTLY MOVED DOWNWARD BY BLOOD FLOW BECAUSE OF THE SLOW DEPLOYMENT ACTION. AFTER THE PROCEDURE, IT WAS CONFIRMED FROM THE IMAGE THAT THE DISTAL MARKER OF GRAFT WAS STILL IN THE OUTER SHEATH DURING DEPLOYMENT (ABOUT 15 MM); HOWEVER, IT WAS NOT RECOGNIZED DURING PROCEDURE. THE DOCTOR CONFIRMED THAT THE DEPLOYMENT GRIP WAS NOT PULLED ENOUGH (ABOUT 3 CM), SO HE PULLED THE DEPLOYMENT GRIP COMPLETELY. AFTER PULLED, ALTHOUGH THE GRIP LOOKED MOVING BACK ABOUT 1 - 2 CM, THE DOCTOR CONSIDERED THAT THE INNER SHEATH WAS FULLY RETRACTED IN THE OUTER SHEATH. IN THE POSITION #3, RELEASED THE STENT GRAFT FROM THE APEX HOLDER AND RETRACTED THE TIP TO THE OUTER SHEATH IN THE POSITION #4; HOWEVER, THE TIP COULD NOT BE RETRACTED DUE TO GETTING STUCK AT THE OUTER SHEATH. PUSHED THE TIP BACK ONCE AND PULLED THE STAINLESS STEEL ROD COMPLETELY. NOW THE TIP SEEMED TO BE RETRACTED, AND THE SYSTEM WAS LOCKED IN THE POSITION #2. (THE DOCTOR COMMENTED THAT THE SYSTEM WAS DIFFICULT TO BE RETRACTED.) AFTER THE PROCEDURE, IT WAS CONFIRMED FROM THE IMAGE THAT: THE DISTAL END OF GRAFT WAS CAUGHT IN THE OUTER SHEATH ABOUT 15 MM AT THIS TIME. SINCE THE WHOLE SYSTEM WAS RETRACTED IN SUCH A STATE, THE STENT GRAFT WAS MIGRATED ABOUT 4 EM. IT WAS NOT RECOGNIZED DURING PROCEDURE. THE GRAFT WAS STOP BEING MIGRATED IN THE NARROW SECTION OF AORTA, THEREFORE THE STENT GRAFT APPEARED TO BE DETACHED FROM OUTER SHEATH. AFTER THE SYSTEM WAS FULLY REMOVED, IT WAS CONFIRMED THAT THE INNER SHEATH AND TIP WERE OUT OF THE OUTER SHEATH ABOUT 1 EM, I.E. NOT COMPLETELY RETRACTED. THE IMPLANT OF PROXIMAL SIDE RELAY (42-250) WAS STARTED. ADJUST THE POSITION JUST BELOW LSA AT ZONE 3. AT THIS POINT, THE OVER LAP AREA LOOKED SMALLER (ABOUT 5.5 CM) THAN PLANNED ONE AND THEREFORE THE DISTAL SIDE STENT GRAFT SEEMED TO BE IMPLANTED AT LOWER POSITION THAN EXPECTED. HOWEVER, THE EXACT POSITION OF DISTAL SIDE STENT GRAFT WAS NOT IDENTIFIED BECAUSE THE ANGIOGRAPHY WAS FOCUSED ON THE PROXIMAL SIDE STENT GRAFT. (THE DOCTOR PRESENTED A VIEW THAT IMPLANTED POSITION WAS LOWER BECAUSE THE STENT GRAFT WAS PUSHED INTO AORTIC ARCH.) DEPLOYED THE STENT GRAFT AND PERFORM A BALLOON TOUCH-UP AROUND JUNCTION AREA OF BOTH GRAFTS. THE GRAFT WAS MOVED DOWNWARD DUE TO EXCESSIVE BLOOD FLOW DURING INFLATION OF BALLOON BUT MOVED BACK WHEN DEFLATED. THE DISTAL SIDE STENT GRAFT SEEMED TO BE MIGRATED SLIGHTLY. ANGIOGRAPHY WAS CONFIRMED AND THE PROCEDURE WAS DONE. ANGIOGRAPHY WAS PERFORMED TO CHECK CA AND SMA AND SHOWED THAT BOTH OF CA AND SMA WAS OCCLUDED BY THE DISTAL SIDE STENT GRAFT. NO HEALTH INJURY OF THE PATIENT WAS DETECTED. THE BYPASS WAS PERFORMED BY OPEN SURGERY. THE BLOOD FLOW WAS CONFIRMED BY ANGIOGRAPHY, AND THE PROCEDURE WAS SUCCESSFULLY DONE."