Description of Event or Problem · 0
AGENT DCB REGISTRY IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON 13-MAY-2021, THE SUBJECT PRESENTED WITH STABLE ANGINA, WAS REFERRED FOR CARDIAC CATHETERIZATION AND WAS ENROLLED INTO THE AGENT DCB REGISTRY STUDY. THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE FIRST TARGET LESION, LOCATED IN THE FIRST DIAGONAL, WAS 70% STENOSED AND 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS PRE-DILATED USING A 2.5 MM X 15 MM BALLOON, FOLLOWED BY TREATMENT WITH A 2.50 MM X 20 MM AGENT DCB WITH 5% RESIDUAL STENOSIS. POST DILATION WAS NOT PERFORMED. THE SECOND TARGET LESION, LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX, WAS 70% STENOSED AND 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE LESION WAS PRE-DILATED WITH A 2.5 MM X 15 MM BALLOON, FOLLOWED BY TREATMENT WITH A 2.75 MM X 30 MM AGENT DCB WITH 0% RESIDUAL STENOSIS. POST DILATION WAS NOT PERFORMED. THE THIRD TARGET LESION, LOCATED IN THE LEFT MAIN CORONARY ARTERY EXTENDING UP TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, WAS 80% STENOSED AND 15 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE LESION WAS PRE-DILATED WITH A 3.5 MM X 12 MM BALLOON, FOLLOWED BY TREATMENT WITH A 3.50 MM X 15 MM AGENT DCB WITH RESIDUAL STENOSIS OF 10%. POST DILATION WAS NOT PERFORMED. THE FOURTH TARGET LESION, LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY, WAS 70 % STENOSED AND 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON, FOLLOWED BY TREATED WITH A 2.50 X 20 MM AGENT DCB WITH 5% RESIDUAL STENOSIS. POST DILATION WAS NOT PERFORMED. THE FIFTH TARGET LESION, LOCATED IN THE FIRST OBTUSE MARGINAL, WAS 70% STENOSED AND 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON, FOLLOWED BY TREATMENT WITH A 2.50 X 30 MM AGENT DCB WITH 10% RESIDUAL STENOSIS. POST DILATION WAS NOT PERFORMED. ON 15-MAY-2021, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2021, 195 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH PROXIMAL LCX CORONARY ARTERY DISEASE AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. THE FOLLOWING DAY, CORONARY ANGIOGRAPHY REVEALED 50% PROXIMAL STENOSIS OF THE LEFT CIRCUMFLEX. THE STENOSIS WAS TREATED BY PERCUTANEOUS CORONARY INTERVENTION USING DRUG COATED BALLOON. POST INTERVENTION, THE RESIDUAL STENOSIS WAS UNKNOWN. ON 27-NOV-2021, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED WITHOUT SEQUELAE. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.