SMART CONTROL ILIAC
Received Jul 21, 2026 · Event occurred Jun 27, 2018
Report 9616099-2026-01007 · MDR key 25894770
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Restenosis
Narrative
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 (150001), IN-STENT RESTENOSIS SEEN IN DUS. A SINGLE SMART CONTROL NITINOL STENT SYSTEM MEASURING 6 × 40 MM WAS IMPLANTED TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY LESION. THE PROCEDURE WAS PERFORMED USING CONTRALATERAL FEMORAL ACCESS WITH A 6F SHEATH UNDER LOCAL ANESTHESIA. THE LESION HAD 65% STENOSIS BEFORE TREATMENT AND WAS SUCCESSFULLY CROSSED WITH A GUIDEWIRE. PRE-DILATATION WAS PERFORMED USING A 6 × 80 MM DRUG-COATED BALLOON, FOLLOWED BY SUCCESSFUL DEPLOYMENT OF THE STENT. THE STENT WAS FULLY DEPLOYED AND FULLY EXPANDED WITH BALLOON DILATATION, RESULTING IN 0% RESIDUAL STENOSIS. NO PROCEDURAL COMPLICATIONS, ADVERSE EVENTS, DEVICE DEFICIENCIES, OR TARGET LESION REVASCULARIZATION OCCURRED DURING THE INDEX HOSPITALIZATION, AND THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE PROCEDURE. AT APPROXIMATELY 9 MONTHS, DUPLEX ULTRASOUND DEMONSTRATED NO TARGET LESION RESTENOSIS OR NEED FOR TARGET LESION REVASCULARIZATION, AND NO ADVERSE EVENTS OR DEVICE DEFICIENCIES WERE REPORTED. AT APPROXIMATELY 21 MONTHS, DUPLEX ULTRASOUND AGAIN SHOWED NO RESTENOSIS, TARGET LESION REVASCULARIZATION, ADVERSE EVENTS, OR DEVICE DEFICIENCIES. AT APPROXIMATELY 38 MONTHS, DUPLEX ULTRASOUND IDENTIFIED >50% IN-STENT RESTENOSIS, REPORTED AS A SEVERE, SERIOUS ADVERSE EVENT REQUIRING HOSPITALIZATION. THE RESTENOSIS WAS DETECTED ON DUPLEX ULTRASOUND, WAS CONSIDERED POSSIBLY RELATED TO THE STUDY DEVICE BUT NOT RELATED TO THE INDEX PROCEDURE, AND RESOLVED FOLLOWING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A CORRESPONDING DEVICE DEFICIENCY OF IN-STENT RESTENOSIS WAS ALSO RECORDED. AT APPROXIMATELY 50 MONTHS, DUPLEX ULTRASOUND DEMONSTRATED NO RECURRENT RESTENOSIS; HOWEVER, TARGET LESION REVASCULARIZATION HAD BEEN PERFORMED WITH A DRUG-COATED BALLOON AND THROMBECTOMY FOR SYMPTOMATIC RESTENOSIS OF =50%. NO NEW ADVERSE EVENTS OR DEVICE DEFICIENCIES WERE REPORTED. AT APPROXIMATELY 63 MONTHS, DUPLEX ULTRASOUND DEMONSTRATED NO RESTENOSIS, NO TARGET LESION REVASCULARIZATION, AND NO ADVERSE EVENTS OR DEVICE DEFICIENCIES. AT APPROXIMATELY 118 MONTHS, DUPLEX ULTRASOUND AGAIN SHOWED NO TARGET LESION RESTENOSIS, NO TARGET LESION REVASCULARIZATION, AND NO ADDITIONAL ADVERSE EVENTS OR DEVICE DEFICIENCIES.