Description of Event or Problem · 1
THE PATIENT WAS DIAGNOSED WITH 7.2 CM INFRARENAL ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 18 MONTHS AGO, THE VASCULAR SURGEON PERFORMED AN ENDOAORTIC STENT GRAFT REPAIR OF INFRARENAL ABDOMINAL AORTIC ANEURYSM USING THE ENDURANT II, 3 PIECE DEVICE. SURGERY AND RECOVERY WERE WITHOUT COMPLICATION AND THE PATIENT WAS DISCHARGED HOME IN A FEW DAYS. APPROXIMATELY TWO WEEKS AGO, THE PATIENT DEVELOPED ACUTE RIGHT LOWER ABDOMINAL PAIN AFTER CHANGING A TIRE. NO LEG PAIN OR DYSPNEA NOTED. HE WAS TRANSFERRED FROM A SISTER HOSPITAL AFTER CT ANGIOGRAM DEMONSTRATED A RUPTURED AAA. CT ANGIOGRAM DEMONSTRATED ENLARGEMENT OF ANEURYSM SAC WITH RETROPERITONEAL BLEEDING AND EXTRAVASATION OF CONTRAST INTO SAC. PRIOR SURVEILLANCE CT THREE WEEKS PRIOR SHOWS ENDOGRAFT IN GOOD POSITION AND WITH STABLE SIZE (7.3 TO 7.2CM). THE PATIENT UNDERWENT 'EMERGENT, OPEN REPAIR OF RUPTURED ABDOMINAL AORTIC ANEURYSM VIA PARTIAL ENDOGRAFT EXCISION AND REPLACEMENT WITH AORTOBIILIAC GRAFT'. FROM THE SURGEON'S NARRATIVE REPORT: 'THERE WAS A TEAR NOTED ON THE ANTERIOR PORTION OF THE WALL OF THE STENT GRAFT,WHICH WAS REPAIRED USING AN INTERRUPTED SILK FIGURE-OF-EIGHT SUTURE'...'THROMBIN-SOAKED GELFOAM AND FLOSEAL WAS USED AROUND THE AREA OF THE STENT GRAFT BOTH PROXIMALLY AND DISTALLY FOR HEMOSTASIS. THE WOUND WAS THEN PACKED AND COMPRESSION WAS HELD. THE WOUND WAS AGAIN INSPECTED AND BRISK BLEEDING WAS NOTED FROM THE PROXIMAL NECK. USING CAUTERY AND METZENBAUM SCISSORS, DISSECTION WAS CARRIED DISTALLY AND THE BILATERAL ILIAC ARTERIES WERE CIRCUMFERENTIALLY DISSECTED. THE ANEURYSM SAC WAS OPENED COMPLETELY FROM THE INFRARENAL NECK DOWN THROUGH THE AORTIC BIFURCATION AND THE GRAFT WAS EXPLANTED BY DIVIDING THE INFRARENAL NECK USING HEAVY SCISSORS AND REMOVING THE DISTAL PORTION OF THE AORTOBIILIAC STENT GRAFT SYSTEM. A 20 X 10 MM VASCUSOFT GRAFT WAS THEN BROUGHT INTOTHE FIELD. THIS WAS CUT TO THE APPROPRIATE LENGTH. AN END-TO-ENDPROXIMAL ANASTOMOSIS WAS THEN MADE BETWEEN THE ENDOGRAFT AND AORTIC WALL IN THE AORTOILIAC GRAFT USING A CV3 GORE-TEX RUNNING SUTURE. THE GRAFT WAS THEN FLUSHED AND THE PROXIMAL ANASTOMOSIS WAS TESTED. MULTIPLE FIGURE-OF-EIGHT 3-0 GORE-TEX SUTURES WERE USED FOR ULTIMATE HEMOSTASIS, WHICH WAS ACHIEVED. 'THE PATIENT RECOVERED FROM THE PROCEDURE AND HAS BEEN DISCHARGED TO A SKILLED NURSING FACILITY.'MANUFACTURER RESPONSE FOR ENDOAORTIC GRAFT STENT, ENDURANT II STENT GRAFT SYSTEM (PER SITE REPORTER)======================MEDTRONIC HAS BEEN VERY ENGAGED IN DIALOGUE ABOUT THE EVENT. THEY WERE VERY QUICK TO EXPRESS INTEREST IN EVALUATION OF THE FAILED GRAFT. THEIR FIELD REP TOOK CUSTODY OF THE GRAFT FOR RETURN TO MEDTRONIC FOR EVALUATION.