Description of Event or Problem · 1
(B)(6) STUDY. IT WAS REPORTED THAT DISSECTION OF THE VESSEL OCCURRED. THE SUBJECT WAS ENROLLED IN (B)(6) STUDY ON (B)(6) 2016 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY ((B)(6) STUDY). THE TARGET LESION #1 WAS IN THE LEFT OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA), PROXIMAL SFA, MID SFA AND DISTAL SFA EXTENDING TO PROXIMAL POPLITEAL ARTERY, WITH 90 % STENOSIS. THE LESION WAS 190 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND DISTAL VESSEL DIAMETER OF 5.5 MM AND WAS CLASSIFIED AS TASC II C LESION. ON (B)(6) 2016, DURING INDEX PROCEDURE, LESION WAS PREDILATED WITH 5 MM X 200 MM MUSTANG BALLOON TO TREAT THE OCCLUSION IN THE TARGET LESION, WHERE SIGNIFICANT RECOIL AND DIFFUSE DISSECTION WERE NOTED. SUBSEQUENTLY, THE TARGET LESION #1 WAS STENTED WITH A TWO 6 MM X 150 MM STUDY STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0 %. ON (B)(6) 2016, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2019, THE SUBJECT PRESENTED TO THE HOSPITAL WITH CLINICALLY SIGNIFICANT SYMPTOMS OF DISABLING CLAUDICATION IN BILATERAL LOWER EXTREMITIES. BASED ON THE ABOVE CONDITION, THE SUBJECT WAS PLANNED FOR ENDOVASCULAR REVASCULARIZATION PROCEDURE BILATERALLY WITH BRACHIAL ANGIOGRAPHY, DUE TO SEVERITY OF SYMPTOMS. ON THE SAME DAY, ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED THAT THE RIGHT LIMB HAD A SEVERE DISEASE IN COMMON FEMORAL ARTERY AND PROXIMAL FEMORAL ARTERY WITH MODERATE TO SIGNIFICANT RESTENOSIS IN MID FEMORAL STENT. LEFT LIMB WAS VERY TIGHT SHELF LIKE LESION IN THE COMMON FEMORAL ARTERY, SIGNIFICANT RESTENOSIS IN THE FEMORAL STENT. BASED ON THE ANGIOGRAPHIC RESULT, IT IS NOTED THAT THAT COMMON FEMORAL ARTERIAL OCCLUSIVE DISEASE WITH FEMORAL RESTENOSIS WHICH WAS WORSE IN LEFT LOWER EXTREMITY THAN RIGHT LOWER EXTREMITY. ON (B)(6) 2019, 90 % STENOSIS NOTED IN THE LEFT PROXIMAL FEMORAL ARTERY STENT, AND COMMON FEMORAL ARTERY AND WERE TREATED BY PERFORMING PERCUTANEOUS ANGIOPLASTY WITH THE HELP OF 5 MM AND 6 MM MUSTANG BALLOONS. POST PROCEDURE THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10 % (TVR) (REPORTED AS (B)(4)). ADDITIONALLY, THE STENOSIS NOTED IN THE RIGHT LOWER EXTREMITY WAS TREATED BY PERFORMING BALLOON ANGIOPLASTY WITH THE HELP OF 5 MM MUSTANG BALLOON AND SATISFACTORY RESULTS WERE ACHIEVED (REPORTED AS (B)(4)). THE SUBJECT WAS NOTED TO HAVE SOME BLEEDING AT THE BRACHIAL SITE WHICH WAS CONTROLLED WITH MANUAL COMPRESSION. ON (B)(6) 2019, SUBJECT WAS DISCHARGED ON ASPIRIN. ON (B)(6) 2019, SUBJECT PRESENTED TO HOSPITAL FOR FOLLOW UP POST INTERVENTION FOR ASSESSMENT OF HIS CONDITION. ON (B)(6) 2019, BOTH THE EVENTS (B)(4) WERE CONSIDERED TO BE RESOLVED.