18 FR DILATOR/SHEATH COOK MEDICAL Report # 1614245
PATIENT PRESENTED WITH NECK MEASURING 21-22MM OVER 20MM OF LENGTH; AORTIC BIFURCATION MEASURING 16MM AND CALCIFIC; CALCIFIED AND MILDLY TORTUOUS ILIAC VESSELS, FLOW LUMEN WAS 6MM (OFF-LABEL) ON THE RIGHT (IPSILATERAL) AND 4MM (OFF-LABEL) ON THE LEFT (CONTRALATERAL). THE VESSELS WERE NOT PREDILATED. USING A MEIER GUIDEWIRE, THE PHYSICIAN WAS UNABLE TO ADVANCE A BIFURCATED DEVICE [25-16-120BL (IT); (B) (4)] PAST THE EXTERNAL ILIAC. THE DEVICE WAS REMOVED, THE ILIAC WAS DILATED USING AN 8X4 BALLOON FROM THE BIFURCATION DOWN TO THE EXTERNAL. AN ATTEMPT WAS MADE AGAIN WITH THE SAME DEVICE, HOWEVER UNSUCCESSFUL. THE DEVICE WAS REMOVED, THE ILIAC WAS DILATED AGAIN USING A 10X4 BALLOON AND THE ENDOLOGIX DILATOR. THE DILATOR WAS ADVANCED UP TO THE AORTA. ANOTHER ATTEMPT WAS MADE WITH THE SAME DEVICE, HOWEVER, IT WAS STUCK ABOUT HALFWAY UP THE AORTA AND COULD NOT GET THE LIMBS PAST THE AORTIC BIFURCATION. THE DEVICE WAS REMOVED. A SUGGESTION WAS MADE TO SWITCH FROM THE MEIER WIRE TO A LUNDERQUIST WIRE. THE PHYSICIAN OPTED FOR A GORE EXCLUDER. USING THE 18FR COOK DILATOR AND SHEATH, THE PHYSICIAN WAS ABLE TO ADVANCE THE DILATOR INTO POSITION, BUT WAS UNABLE TO ADVANCE THE SHEATH INTO POSITION. IT WAS NOTED THAT THE PHYSICIAN PUSHED HARD A FEW TIMES. THE SHEATH WAS REMOVED AND THE PATIENT'S BP DROPPED. THE RIGHT EXTERNAL ILIAC HAD DISSECTED DURING THE 18FR SHEATH INTRODUCTION. THE PATIENT WAS CONVERTED TO OPEN REPAIR AND TOLERATED THE PROCEDURE WELL.
18 FR DILATOR/SHEATH COOK MEDICAL Report # 1614245
(B) (4) DEVICE MANUFACTURED BY COOK MEDICAL.
18 FR DILATOR/SHEATH COOK MEDICAL Report # 1614245
PATIENT PRESENTED WITH NECK MEASURING 21-22MM OVER 20MM OF LENGTH; AORTIC BIFURCATION MEASURING 16MM AND CALCIFIC; CALCIFIED AND MILDLY TORTUOUS ILIAC VESSELS, FLOW LUMEN WAS 6MM (OFF-LABEL) ON THE RIGHT (IPSILATERAL) AND 4MM (OFF-LABEL) ON THE LEFT (CONTRALATERAL). THE VESSELS WERE NOT PREDILATED. USING A MEIER GUIDEWIRE, THE PHYSICIAN WAS UNABLE TO ADVANCE A BIFURCATED DEVICE [25-16-120BL (IT); (B) (4)] PAST THE EXTERNAL ILIAC. THE DEVICE WAS REMOVED, THE ILIAC WAS DILATED USING AN 8X4 BALLOON FROM THE BIFURCATION DOWN TO THE EXTERNAL. AN ATTEMPT WAS MADE AGAIN WITH THE SAME DEVICE, HOWEVER UNSUCCESSFUL. THE DEVICE WAS REMOVED, THE ILIAC WAS DILATED AGAIN USING A 10X4 BALLOON AND THE ENDOLOGIX DILATOR. THE DILATOR WAS ADVANCED UP TO THE AORTA. ANOTHER ATTEMPT WAS MADE WITH THE SAME DEVICE, HOWEVER, IT WAS STUCK ABOUT HALFWAY UP THE AORTA AND COULD NOT GET THE LIMBS PAST THE AORTIC BIFURCATION. THE DEVICE WAS REMOVED. A SUGGESTION WAS MADE TO SWITCH FROM THE MEIER WIRE TO A LUNDERQUIST WIRE. THE PHYSICIAN OPTED FOR A GORE EXCLUDER. USING THE 18FR COOK DILATOR AND SHEATH, THE PHYSICIAN WAS ABLE TO ADVANCE THE DILATOR INTO POSITION, BUT WAS UNABLE TO ADVANCE THE SHEATH INTO POSITION. IT WAS NOTED THAT THE PHYSICIAN PUSHED HARD A FEW TIMES. THE SHEATH WAS REMOVED AND THE PATIENT'S BP DROPPED. THE RIGHT EXTERNAL ILIAC HAD DISSECTED DURING THE 18FR SHEATH INTRODUCTION. THE PATIENT WAS CONVERTED TO OPEN REPAIR AND TOLERATED THE PROCEDURE WELL.
18 FR DILATOR/SHEATH COOK MEDICAL Report # 1614245
[(B) (4)] DEVICE MANUFACTURED BY COOK MEDICAL.