SMART FLEX

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

AS REPORTED ON SMART STUDY (B)(4), ILIAC OCCLUSION AND SFA OCCLUSION OCCURRED. AN IN-STENT STENOSIS/STENOSIS SFA (NOT INSTENT) WAS NOTED. THERE WAS NO DEVICE DEFICIENCY. THE PATIENT UNDERWENT TREATMENT OF A RIGHT SUPERFICIAL FEMORAL ARTERY LESION WITH IMPLANTATION OF A SINGLE SMART FLEX VASCULAR STENT MEASURING 5 MM × 40 MM. THE TARGET LESION MEASURED APPROXIMATELY 15 MM WITH 75% STENOSIS BEFORE TREATMENT. PRE-DILATATION WAS PERFORMED USING A 5 MM × 120 MM NON-COMPLIANT BALLOON, REDUCING STENOSIS TO 50% BEFORE STENT IMPLANTATION. DURING PRE-DILATATION, A MILD ARTERIAL DISSECTION OCCURRED, WHICH WAS NOT RELATED TO THE SMART STENT AND WAS SUCCESSFULLY MANAGED BY STENT IMPLANTATION DURING THE INDEX PROCEDURE. THE SMART FLEX STENT WAS FULLY DEPLOYED AND FULLY EXPANDED WITHOUT BALLOON POST-DILATATION, RESULTING IN 0% RESIDUAL STENOSIS. NO TARGET LESION REVASCULARIZATION WAS REQUIRED BEFORE DISCHARGE, AND NO DEVICE DEFICIENCIES WERE REPORTED. AT APPROXIMATELY 19 MONTHS POST-PROCEDURE, MRI/MRA DEMONSTRATED 0% RESIDUAL STENOSIS, WITH NO TARGET LESION RESTENOSIS, TARGET LESION REVASCULARIZATION, ADVERSE EVENTS, OR DEVICE DEFICIENCIES REPORTED. AT APPROXIMATELY 21 MONTHS, ANGIOGRAPHY IDENTIFIED >50% IN-STENT RESTENOSIS DESPITE A RECORDED RESIDUAL STENOSIS OF 0%. THE PATIENT UNDERWENT TARGET LESION REVASCULARIZATION WITH A DRUG-COATED BALLOON (DCB) FOR SYMPTOMATIC RESTENOSIS. THE EVENT WAS REPORTED AS MILD IN-STENT RESTENOSIS, CONSIDERED POSSIBLY RELATED TO THE SMART FLEX STENT BUT NOT RELATED TO THE INDEX PROCEDURE, AND RESOLVED FOLLOWING DCB ANGIOPLASTY. NO DEVICE DEFICIENCY WAS IDENTIFIED. AT APPROXIMATELY 40 MONTHS, CT IMAGING SHOWED 0% RESIDUAL STENOSIS WITH NO TARGET LESION RESTENOSIS OR REVASCULARIZATION. A SEPARATE ADVERSE EVENT OF SUPERFICIAL FEMORAL ARTERY STENOSIS OUTSIDE THE STENTED SEGMENT (NOT IN-STENT) WAS REPORTED, CONSIDERED NOT RELATED TO THE SMART FLEX STENT OR INDEX PROCEDURE, REQUIRED NO INTERVENTION, REMAINED ONGOING, AND NO DEVICE DEFICIENCY WAS IDENTIFIED. A SUBSEQUENT ANGIOGRAPHIC ASSESSMENT AT APPROXIMATELY THE SAME TIME AGAIN DOCUMENTED >50% TARGET LESION RESTENOSIS WITHOUT TARGET LESION REVASCULARIZATION OR DEVICE DEFICIENCY. AT APPROXIMATELY 61 MONTHS, CT IMAGING DEMONSTRATED 80% RESIDUAL STENOSIS WITH >50% TARGET LESION RESTENOSIS. A SEPARATE SERIOUS ADVERSE EVENT OF ILIAC OCCLUSION AND SUPERFICIAL FEMORAL ARTERY OCCLUSION WAS REPORTED AT THIS TIME. THE EVENT WAS CONSIDERED NOT RELATED TO THE SMART FLEX STENT OR THE INDEX PROCEDURE, WAS MANAGED WITH BIFURCATION GRAFT (BIF) SURGERY, WITH THE SFA REMAINING OCCLUDED, AND REMAINED ONGOING. NO DEVICE DEFICIENCY OR TARGET LESION REVASCULARIZATION WAS REPORTED. AT APPROXIMATELY 124 MONTHS, CT IMAGING DEMONSTRATED 100% RESIDUAL OCCLUSION OF THE TARGET LESION. NO NEW TARGET LESION RESTENOSIS, TARGET LESION REVASCULARIZATION, ADVERSE EVENTS, OR DEVICE DEFICIENCIES WERE REPORTED SINCE THE PREVIOUS FOLLOW-UP.