Description of Event or Problem · 1
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE SUBJECT WAS ENROLLED IN THE RANGER II SFA STUDY ON (B)(6) 2018 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL ARTERY(SFA) AND HAD 95% STENOSIS WITH REFERENCE VESSEL DIAMETER OF 4MM, A LENGTH OF 110MM. THE LESION WAS TREATED WITH PRE-DILATATION USING 4 MM X 100 MM COYOTE BALLOON. REPEAT ANGIOGRAPHY DEMONSTRATED IMPROVEMENT IN VESSEL WITH TYPE B NONFLOW LIMITING DISSECTION. FOLLOWING THIS, A 4 MM X 100 MM RANGER DCB WAS USED FOR TREATING THE TARGET LESION HOWEVER, DISCOVERED 80 CM SHAFT COULD NOT REACH THE DISTAL END OF THE LESION. THE BALLOON WAS REMOVED AND DISCARDED. THEN, 4 MM X 80 MM AND 4 MM X 60 MM STUDY BALLOONS WERE USED FOR TREATING THE TARGET LESION WITH 10% RESIDUAL STENOSIS. POST DILATATION WAS NOT PERFORMED AND WAS TREATED AS AN OUTPATIENT. ON (B)(6) 2019, THE VELOCITY OF THE MID RIGHT SFA WAS 670 M/S. ARTERIAL DUPLEX BILATERAL ULTRASOUND L FINDINGS REVEALED SEVERE REDUCTION IN THE RIGHT ABI (0.55 AT THE POSTERIOR TIBIAL AND 0.27 AT DORSALIS PEDIS) AND MODERATE REDUCTION IN LEFT ANKLE-BRACHIAL INDEX (ABI) (0.74 AT THE POSTERIOR TIBIAL AND 0.64 AT DORSALIS PEDIS) ALONG WITH CRITICAL RESTENOTIC LESION IN THE MID RIGHT SFA. ON (B)(6) 2019, 95% STENOSIS IN THE MID TO DISTAL RIGHT SFA TARGET LESION WAS TREATED WITH ANGIOPLASTY USING 5 MM X 100 MM CHARGER BALLOON. REPEAT ANGIOGRAPHY REVEALED FLOW REVEALED A LIMITING DISSECTION. HENCE, A 6MM X 120 MM ELUVIA SELF-EXPANDING DRUG-ELUTING STENT WAS THEN PLACED ACROSS THE SHOULDERS OF THE TREATED SEGMENT, COVERING THE DISTAL STENOSIS AT HUNTER'S CANAL. POST-DILATION WAS PERFORMED WITH 5MM BALLOON WITH 0% RESIDUAL STENOSIS, WHICH WAS CONFIRMED BY ANGIOGRAPHY. THE EVENT WAS CONSIDERED TO BE RECOVERING / RESOLVING AND DURING THIS EVENT, THE SUBJECT WAS ON CLOPIDOGREL.