Description of Event or Problem · 1
NINE MONTHS POST STENT IMPLANT, THE STENT WAS FOUND UNDEREXPANDED. THE PATIENT ENROLLED IN THE STUDY; DURING THE INDEX PROCEDURE, THE PATIENT WAS ASYMPTOMATIC. THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID (R5). PRIOR TO THE REVASCULARIZATION PROCEDURE, AN ULTRASOUND WAS CONDUCTED OF THE RIGHT AND LEFT SIDES, THE TARGET LESION PRESENTED 90% STENOSIS. THE TARGET LESION WAS 10MM LONG AND PRESENTED WITH A REFERENCE VESSEL DIAMETER OF 535 MM; ARCH TYPE I. THE LESION WAS ECCENTRIC, PRESENTING CONCENTRIC AND MODERATE CALCIFICATION AND MILD VESSEL TORTUOSITY. DURING THE PROCEDURE, THE LESION WAS SUCCESSFULLY PRE-DILATED. THEN A 6MM ANGIOGUARD WAS SUCCESSFULLY POSITIONED WHICH WAS FOLLOWED BY SUCCESSFUL STENTING OF AN 8X30MM PRECISE STENT. NO MALFUNCTION OR ADVERSE EVENTS WERE ASSOCIATED WITH THE STENT IMPLANT. THE ANGIOGUARD FILTER WAS RETRIEVED FROM THE PATIENT WITHOUT ANY COMPLICATIONS. THERE WERE NO TRACES OF ANY DEBRIS ON THE FILTER. POST-STENTING, THE TARGET LESION PRESENTED A 20% DIAMETER STENOSIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE, THERE WAS NO NEUROLOGICAL DEFICIT. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED. DURING THE 30 DAY FOLLOW UP, THE PATIENT REMAINED ASYMPTOMATIC. APPROXIMATELY NINE MONTHS POST PROCEDURE, DURING A VACATION, THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT. THE PATIENT PRESENTED WITH APHASIA. THE PATIENT WAS ADMITTED AT THE HOSPITAL AND WAS KEPT OVERNIGHT FOR OBSERVATION. THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACKS (TIA). THE DURATION OF THE NEUROLOGICAL DEFICIT WAS < 24 HRS. THE ONSET WAS SUDDEN AND THE RECOVERY WAS REPORTED AS PARTIAL, MINOR RESIDUAL. THERE WAS NO TREATMENT. UPON THE PATIENT'S RETURN FROM VACATION, THE PATIENT HAD AN ANGIOGRAM; RESULTS INDICATED THERE WAS POOR EXPANSION OF THE STENT WITHIN THE PROXIMAL SEGMENT OF THE INTERNAL CAROTID ARTERY, CAUSING THE APPEARANCE OF ABOUT 60% OCCLUSIVE LESION. THE OCCLUSION IS NOT INSTENT RESTENOSIS BY APPEARANCE, BUT APPEARED TO BE RECOIL AND POOR EXPANSION OF THE STENT IN THE FOCAL AREA MOST LIKELY DUE TO VASCULAR CALCIFICATIONS, WHICH ARE HEAVY IN THE AREA. AFTER CONSULTATION WITH THE PATIENT'S NEUROLOGIST, IT WAS FELT THAT THE PATIENT EXPERIENCED EITHER A NON-NEUROLOGICAL EVENT OR A POSTERIOR CIRCULATION EVENT. CONSEQUENTLY IT WAS RECOMMENDED THAT THE PATIENT BE MEDICALLY MANAGED AND OBSERVED AT THIS POINT AND NOT HAVE ANY INTERVENTION DONE FOR THE MODERATE RIGHT INTERNAL CAROTID INSTENT LESION DESCRIBED ABOVE. THERE WERE NO MAJOR ADVERSE EVENTS REPORTED FOR THE PATIENT DURING THE TWELVE-MONTH FOLLOW UP. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.