Description of Event or Problem · 1
AFTER DEPLOYING THE BIFURCATED GRAFT, THE POLYTETRAFLUOROETHYLENE (PTFE) LIMB COVER FROM THE LEFT SIDE FAILED TO DETACH AND COME OUT THROUGH THE 8 FR SHEATH. THE FIRST ATTEMPT TO CAPTURE THE COVER WITH A ENSNARE SYSTEM FAILED AND THE DISTAL PART OF THE ENSNARE SYSTEM BROKE OFF AND STAYED INTRAVASCULAR, BUT OUTSIDE THE ENDOLOGIX LEFT LIMB. THE SECOND ATTEMPT WAS TO EXTEND THE COVER WITH A BALLOON AND TRY TO BREAK IT. A 12MM X 2CM CONQUEST BALLOON BROKE THE PTFE COVER AND PUSHED IT AGAINST THE VESSEL AND WAS COVERED BY THE STENT GRAFT (LEFT LIMB). THE FOLLOWING NOTES ARE FROM THE M.D.'S OPERATIVE REPORT: "THE GRAFT AND THE RIGHT LIMB WERE DEPLOYED SATISFACTORILY. AT THIS POINT IN TIME IT WAS APPARENT THAT THERE WAS INCOMPLETE DEPLOYMENT OF THE LEFT SIDE. IT WAS FELT AT THIS POINT THAT PART OF THE DEPLOYMENT SYSTEM DID NOT BECOME DISLODGED BASED ON WHAT WAS REMOVED FROM THE CONTRALATERAL SYSTEM. AN ATTEMPT WAS MADE TO SNARE THIS OUTER COVERING OF THE LIMB BY PLACING A SNARE OVER THE LIMB; HOWEVER, THIS WAS UNSUCCESSFUL AND ALSO RESULTED IN DISLODGEMENT OF THE SNARE BETWEEN THE ENDOGRAPH LIMB AND THE ILIAC ARTERY. IT WAS FELT THAT THIS COULD BE SECURED BETWEEN THESE TWO (2) STRUCTURES ONCE THE LIMB WAS DEPLOYED AND THAT NO FURTHER INTERVENTION WOULD BE REQUIRED WITH THIS RESPECT. USING A 10-MM BALLOON AND A 10-MM CONQUEST BALLOON, ULTIMATELY THE LIMB WAS OPENED UP..." THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME LATER THE SAME DAY.THE DEVICE HAS BEEN USED TWICE AT THIS FACILITY AND THE DEVICE WAS DEPLOYED UNDER THE DIRECTION OR THE MANUFACTURER REPRESENTATIVE.