Cordis S.M.A.R.T. Vascular Stent System C06120MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032063385), received between Oct 5, 2017 and Dec 17, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A CASE FROM (B)(6) FOR SFA AND THE CASE NUMBER IS (B)(4). A SMART STENT AND A SMART CONTROL STENT WAS IMPLANTED IN THE MIDDLE PORTION OF THE RIGHT FEMORAL ARTERY. FIVE YEARS LATER, LOWER EXTREMITY ARTERIOGRAPHY CONFIRMED IN-STENT RE-OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AN UNKNOWN BALLOON CATHETER WAS "USE" FOR DILATION AND A STENT WAS IMPLANTED. THE ABI LEVEL OF THE LESION HAVE BEEN DECREASE AND WAS CONFIRMED TO BE 0.52 AND 0.98. THE RIGHT BELOW THE KNEE HAD A PAIN WHEN THE PATIENT RESTED. TARGET LESION WAS REVASCULARIZATION WAS PERFORMED AND THE PATIENT RECOVERED.

  Patient problems: Occlusion

  MAUDE report 8169321 ↗
• InjuryOct 5, 2017Occlusion Within Device; Occlusion Within Device

  THE REPORT RECEIVED INDICATED THAT THE PATIENT WAS ENROLLED IN A CLINICAL STUDY (B)(6) SMART PMS FOR SFA. THE PATIENT HAD A 120/150 SMART SFA 6 X 120 STENT IMPLANTED DURING THE STUDY INDEX PROCEDURE WITH NO REPORTED ISSUE. THE TARGET LESION WAS THE MIDDLE PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS REPORTED TO BE CALCIFIED. NO OTHER TARGET LESION CHARACTERISTIC INFORMATION INCLUDING THE PERCENT STENOSIS WAS PROVIDED. APPROXIMATELY FORTY THREE (43) MONTHS AFTER THE STUDY INDEX PROCEDURE, THE PATIENT NOTICED A RASH ON THE LEFT ANKLE AND ACHE WHEN RESTING. THE PATIENT VISITED THE HOSPITAL. IN-STENT-RESTENOSIS (ISR) OF THE LEFT SUPERFICIAL FEMORAL ARTERY WAS SUSPECTED DUE TO NO IMPROVEMENT OF TIBIAL PERONEAL TRUNK (TPT) FLOW, AND ENDOVASCULAR TREATMENT (EVT)/STENT IMPLANTATION WAS PERFORMED. THE PATIENT RECOVERED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RELATIONSHIP OF THE REPORTED ADVERSE EVENT (AE) OF RASH TO THE STUDY DEVICE/PROCEDURE WAS NOT APPLICABLE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RELATIONSHIP OF THE REPORTED ADVERSE EVENT (AE) OF LEFT ANKLE ACHE TO THE STUDY DEVICE/PROCEDURE WAS NOT APPLICABLE. ADDITIONAL INFORMATION WAS REQUEST

  Patient problems: Reocclusion

  MAUDE report 6916901 ↗