Description of Event or Problem · 1
SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2012. A REVIEW OF PRE-OP IMAGING INDICATED THAT THE NATIVE AORTIC VESSEL DIAMETER EXCEEDED THE MAXIMUM TREATMENT RANGE OF THE LARGEST OVATION AORTIC BODY STENT GRAFT SIZE; HOWEVER, THE PHYSICIAN PROCEEDED WITH THE CASE SINCE THE PATIENT WOULD NOT LIKELY SURVIVE OPEN SURGICAL REPAIR AND NO OTHER ENDOVASCULAR DEVICE COULD TREAT THE PATIENT. TO COMPENSATE FOR THE LARGE AORTIC VESSEL DIAMETER, THE PHYSICIAN PLACED THE STENT GRAFT HIGHER THAN NORMAL, WITH A SEALING RING AT THE RENAL LEVEL, AND PERFORMED A CHIMNEY GRAFT PROCEDURE USING AN UNCOVERED RENAL STENT. AN ENDOLEAK RESULTED AT THE INTERFACE BETWEEN THE RENAL STENT AND THE SEALING RING. COILS WERE USED IN AN UNSUCCESSFUL ATTEMPT TO EMBOLIZE THE ENDOLEAK. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND RE-INTERVENE AT A LATER DATE TO ADDRESS THE UNRESOLVED ENDOLEAK. WHILE THE SUBJECT WAS WAITING FOR RE-INTERVENTION (APPROX. 4-5 MONTHS) TO TREAT THE ENDOLEAK, THE PATIENT SUFFERED A CONTAINED RUPTURE REQUIRING IMMEDIATE SURGERY DURING WHICH THE DEVICE WAS EXPLANTED BY A DIFFERENT PHYSICIAN. THE PATIENT WAS IN ICU FOR APPROXIMATELY 13 DAYS AFTER THE SURGERY, AND EXPIRED DURING THIS STAY IN ICU.