Description of Event or Problem · 1
TYPE 3 ENDOLEAK AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM (AAA EVAR) FROM (B)(6) 2014 OP NOTE: "INDICATION: (B)(6) Y/O FEMALE WITH HISTORY TYPE A AORTIC DISSECTION S/P PROXIMAL REPAIR IN (B)(6) 2010. SHE HAS RESIDUAL TYPE B WITH NO REMAINING PROXIMAL FENESTRATION BUT DOES HAVE A LARGE DISTAL FENESTRATION IN THE AAA SAC WITH RETROGRADE FLOW INTO FALSE LUMEN. HER CELIAC HAS FLOW FROM TRUE AND FALSE LUMENS, SMA, BILATERAL RENAL ARTERIES, IMA, AND BILATERAL CIAS FILL VIA TRUE LUMEN. SHE IS ASYMPTOMATIC WITH 6 CM AAA COMPONENT." "PROCEDURE: ANGIO WAS DONE WITHOUT BALLOONING. THE RENAL ARTERIES, COMMON, INTERNAL AND EXTERNAL ILIAC ARTERIES WERE PATENT WITHOUT STENOSIS. THERE WAS A LARGE ENDOLEAK IN THE ANEURYSM SAC DISTALLY AT OR VERY NEAR THE FLOW DIVIDER OF THE MAIN BODY DEVICE. DECISION WAS MADE TO PROCEED WITH BALLOONING THE MAIN BODY AND VELA PROXIMAL EXTENSION JUNCTION. THIS WAS DONE THROUGH THE RIGHT FEMORAL SHEATH USING THE CODA BALLOON. THE ILIAC LIMBS WERE ALSO BALLOONED WITH CODA ON THE RIGHT AND WITH A 12 MM X 4 CM BALLOON ON THE LEFT, BOTH WITH HAND INFLATION. REPEAT ANGIO WITH BALLOONS INFLATED DID NOT RESOLVE THE ENDOLEAK, WHICH SEEMED TO BE A TYPE 3 ENDOLEAK NEAR THE FLOW DIVIDER OF THE MAIN BODY DEVICE. AT THIS POINT, IT SEEMED THE ONLY WAY TO RESOLVE THE PROBLEM WAS TO PLACE A SECOND MAIN BODY DEVICE INSIDE THE FIRST ONE; THIS WAS AN ENDOLOGIX A25-25/C95-020 V (SERIAL NUMBER (B)(4)). THE DEVICE WAS DELIVERED AND DEPLOYED AS DESCRIBED ABOVE FOR THE FIRST MAIN BODY DEVICE. THE CROTCH OF THE SECOND DEVICE WAS POSITIONED JUST ABOVE THAT OF THE FIRST DEVICE. THE SECOND DEVICE WAS BALLOONED ALONG ITS ENTIRE LENGTH AND COMPLETION ANGIO WAS DONE, WHICH SHOWED RESOLUTION OF THE TYPE 3 ENDOLEAK. DIAGNOSIS OR REASON FOR USE: 6 CM AAA. "IS THE PRODUCT COMPOUNDED: NO, IS THE PRODUCT OVER THE COUNTER: NO." SECOND TYPE 3 ENDOLEAK OCCURRED IN THIS PT ON (B)(6) 2016; REQUIRED RELINING.