Description of Event or Problem · 1
SONOMA REGISTRY: SAME CASE AS MFR REPORT #: 2134265-2008-01454, -01457, -01460, -01461. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING PROCEDURE, THE TIP OF THE STENT DELIVERY SYSTEM DETACHED AND DIFFICULTY WAS ENCOUNTERED IN RECAPTURING THE FILTER. ACCESS FOR THE PROCEDURE WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY WITH A 5FR SHEATH AND 5FR PIGTAIL CATHETER FOR AORTIC ARCH ANGIOGRAPHY. ANOTHER MFR'S 5FR CATHETER WAS USED TO PERFORM SELECTIVE RIGHT AND LEFT CAROTID AND INTRACRANIAL ANGIOGRAPHY IDENTIFYING A LESION IN THE PROXIMAL LEFT INTERNAL CAROTID WITH 90% STENOSIS AND MEASURING 6X20MM. ANOTHER MFR'S 6FR 90CM SHEATH WAS ADVANCED TO THE COMMON CAROTID ARTERY WITHOUT DIFFICULTY. A FILTERWIRE EZ EMBOLIC PROTECTION WIRE WAS PLACED AND DEPLOYED IN THE INTERNAL CAROTID ARTERY WITHOUT DIFFICULTY AND THE LESION WAS PREDILATED WITH A 4.0X20MM STERLING BALLOON. A NEXSTENT WAS DEPLOYED WITHOUT DIFFICULTY, HOWEVER, IT WAS NOTED THAT THE STENT "JUMPED" AND THE MOST PROXIMAL PORTION OF THE LESION WAS NOT COVERED. ON WITHDRAWAL OF THE NEXSTENT DELIVERY SYSTEM, THE DISTAL PORTION OF THE NOSE CONE BECAME CAUGHT ON THE END OF THE SHEATH AND DETACHED WHILE REMAINING OVER THE FILTERWIRE. AN ATTEMPT WAS MADE TO RECAPTURE THE FILTERWIRE BASKET, BUT WAS UNSUCCESSFUL "BECAUSE OF THE NOSE CONE BEING IN PLACE". THE FILTERWIRE WAS REMOVED BY PULLING THE WIRE UP TO THE SHEATH REMOVING ALL DEVICES AS A UNIT. A SECOND FILTERWIRE EZ WAS ADVANCED THROUGH THE DEPLOYED, BUT NOT POST DILATED NEXSTENT AND DEPLOYED. POST DILATION USING A 5.0X20MM STERLING BALLOON WAS COMPLETED. A SECOND NEXSTENT WAS ADVANCED AND DEPLOYED OVERLAPPING THE FIRST NEXSTENT, COVERING THE ENTIRE LESION. DIFFICULTIES WERE AGAIN ENCOUNTERED IN REMOVING THE NEXSTENT DELIVERY SYSTEM AND THE NOSE CONE AGAIN DETACHED WHILE REMAINING OVER THE FILTERWIRE. MULTIPLE CATHETERS WERE USED IN AN ATTEMPT TO REMOVE THE FILTERWIRE AND DETACHED NEXSTENT NOSE CONE, AND THE PHYSICIAN PROCEEDED WITH POST DILATION OF THE SECOND NEXSTENT USING A 5.0X20MM STERLING BALLOON. FOLLOWING POST DILATION, AN ATTEMPT TO REMOVE THE FILTERWIRE IN A NON-CAPTURED STATE RESULTED IN THE FILTERWIRE LOOP CATCHING ON THE STRUTS OF THE SECOND NEXSTENT AND PULLED INTO THE COMMON CAROTID ARTERY. THE FILTERWIRE WAS EVENTUALLY RECAPTURED USING ANOTHER MFR'S 0.035" CATHETER WITH "ALL COMPONENTS INTACT AND PRESENT." A THIRD FILTERWIRE EZ EMBOLIC PROTECTION WIRE WAS DEPLOYED SUCCESSFULLY AND ANOTHER MFR'S SELF EXPANDING STENT WAS PLACED OVERLAPPING THE NEXSTENTS. THE STENTS WERE POST DILATED USING A 5.0X20MM STERLING BALLOON SUCCESSFULLY. FURTHER DILATION WAS PERFORMED WITH AN 8.0X20MM STERLING BALLOON TO 14 ATM, HAD A PROXIMAL WAIST, FULLY EXPANDED, AND THE BALLOON RUPTURED. THE THIRD FILTERWIRE WAS SUCCESSFULLY RECAPTURED AND FINAL ANGIOGRAPHY SHOWED AN "EXCELLENT" RESULT WITH FULL LESION COVERAGE, FULL STENT EXPANSION, AND 0% RESIDUAL STENOSIS. IT WAS REPORTED THAT THE PT REMAINED NEUROLOGICALLY AND HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PT EXPERIENCED A TIA (TRANSIENT ISCHEMIC ATTACK) POST PROCEDURE AND PRIOR TO DISCHARGE. THE INVESTIGATOR ASSESSED THE TIA AS UNRELATED TO THE NEXSTENT AND FILTERWIRE DEVICES AND PROBABLY RELATED TO THE PROCEDURE. THE PT WAS REPORTED TO BE RECOVERING.