Cordis S.M.A.R.T. Vascular Stent System C07150MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 20705032063439), received between Aug 25, 2016 and Aug 3, 2023 — classified as 1 death, 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (5 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE STENT OF A 7MM X 150MM SMART SUPERFICIAL FEMORAL ARTERY (SFA) SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS PARTIALLY DEPLOYED. THE STENT WAS ABLE TO BE RETRIEVED AND REMOVED WITHOUT DIFFICULTIES. THERE WERE NO REPORTED INJURIES TO THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN HELD THE DEVICE BY THE DEPLOYMENT SHEATH DURING STENT DEPLOYMENT AND THE STENT JUMPED FORWARD WHEN ATTEMPTING TO RELEASE. ANGIOGRAMS WERE PERFORMED DURING THE PROCEDURE, BUT A FINAL ANGIOGRAM TO CONFIRM PLACEMENT OF THE STENT WAS NOT PERFORMED PRIOR TO ATTEMPTING TO RELEASE THE STENT. THIS WAS DURING A PROCEDURE TO TREAT A LESION WITH SEVERE CALCIFICATION. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453584 ↗
• MalfunctionApr 26, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE PACKAGE OF THE 7X150MM SMART 120 STENT WAS OPENED, AND STENT WAS NOTED TO BE PARTIALLY DEPLOYED. THE PATIENT WAS FINE WITH NO INJURY. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, BOTH WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16816814 ↗
• MalfunctionSep 20, 2021Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 7 X 150MM SMART SELF-EXPANDING STENT WAS BEING DELIVERED BUT IT WAS DIFFICULT FOR THE COMPLAINT DEVICE TO CROSS. IT WAS REMOVED ONCE, AND THE PHYSICIAN NOTICED THE DISTAL TIP WAS FRAYED. THEREFORE, IT WAS REPLACED WITH ANOTHER UNKNOWN SMART STENT AND IT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE LOCKING PIN WAS NOT REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. THE SDS WAS NOT ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. THE IFU INSTRUCTS THE USER TO HOLD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT AND THIS WAS DONE. THE TANTALUM MARKERS (SMART CONTROL) WERE OBSERVED TO OPEN SYMMETRICALLY BECAUSE IT WAS NOT OPENED. THE TARGET VESSEL WAS THE ILIAC ARTERY. THE PRODUCT INVENTORY WAS STORED ON A SHELF. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 12500502 ↗
• MalfunctionJan 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 120 150 7X150MM SMART VASCULAR SELF-EXPANDING STENT DELIVERY SYSTEM (SES) WAS DAMAGED UPON OPENING THE PACKAGING. THE DAMAGED MEANS SEPARATED, AND IT WAS NOTED AT THE SHAFT OF THE STENT/PUSHER. AS STATED BY THE CUSTOMER, THEY WERE NOT MATCHED UP, THEREFORE, THEY COULD NOT FEED A WIRE THRU THE LUMEN. THERE WAS NO DAMAGED NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS A PERIPHERAL PROCEDURE. THE DEVICE WAS PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THE PROCEDURE WAS COMPLETED USING A NEW UNKNOWN STENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9574462 ↗
• InjuryOct 30, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING DEPLOYMENT OF A 7X150MM SMART STENT, RESISTANCE WAS FELT WHEN CROSSING THE LESION SO THE PHYSICIAN APPLIED FORCE TO PUSH, HOWEVER THE OUTER SHEATH SLID AND THE STENT WAS DEPLOYED BY MISTAKE. THEREFORE, IT WAS REPLACED WITH A NEW STENT WHICH WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN COMMENTED THAT THE Y CONNECTOR VALVE MIGHT HAVE BEEN RELEASED. THE LESION WAS THE LEFT THE COMMON ILIAC ARTERY WITH STENOSIS. AN APPROACH WAS MADE FROM THE LEFT BRACHIAL ARTERY. A SMART STENT WAS ATTEMPTED TO BE DELIVERED TO THE LESION WHEN THE RESISTANCE WAS FELT. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. ADDITIONAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019497 ↗
• MalfunctionJul 3, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE AFTER PRE-DILATION, THE PHYSICIAN WAS NOT ABLE TO CROSS THE TARGET LESION WITH THE 120/150 SMART SFA 7 X 150 STENT DELIVERY SYSTEM (SDS). THE PRODUCT WAS REMOVED, AND PRE-DILATION WAS PERFORMED AGAIN. THE SMART SDS WAS RE-INSERTED BUT STILL DID NOT CROSS THE TARGET LESION. AFTER REMOVING THE PRODUCT AGAIN, IT WAS NOTED THAT THERE WAS SOME GAP BETWEEN ITS OUTER SHEATH AND ITS DISTAL TIP. A NON-CORDIS STENT WAS USED AND WAS IMPLANTED WITHOUT ANY ISSUE. TWO (2 EACH) ADDITIONAL SMART STENTS WERE IMPLANTED SUCCESSFULLY IN THE LEFT ILIAC ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESIONS WERE THE LEFT ILIAC ARTERY AND THE LEFT SUPERFICIAL FEMORAL ARTERY. AN APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659991 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE YEARS AFTER A SMART STENT WAS IMPLANTED IN THE MIDDLE PORTION OF THE RIGHT FEMORAL ARTERY, RE-VASCULARIZATION WAS PERFORMED ON THE TARGET LESION. THREE MONTHS LATER, INTERMITTENT CLAUDICATION WAS CONFIRMED AND ONE YEAR LATER, INTERMITTENT CLAUDICATION WAS CONFIRMED AGAIN. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED AND THE PATIENT RECOVERED. THE SMART STENT WAS IMPLANTED IN THE TARGET LESION WITHOUT ANY ISSUE. THE ANKLE-BRACHIAL INDEX LEVEL WAS CONFIRMED TO HAVE BEEN DECREASED. THIS IS A CASE FROM (B)(6) SMART PMS FOR SFA.

  Patient problems: Claudication; Stenosis

  MAUDE report 7494093 ↗
• MalfunctionMar 6, 2018Bent; Difficult or Delayed Positioning; Kinked; Bent; Difficult or Delayed Positioning; Kinked

  DURING PREP, A SMART STENT 7X150MM WAS PREPARED AND FLUSHED. HOWEVER THE SHAFT GOT KINKED EASILY. ADDITIONAL INFORMATION WAS RECEIVED AND DURING FAL ANALYSIS, IT WAS NOTED THAT THE STENT WAS PREMATURE DEPLOYED. THE DEVICE WAS REPLACED WITH A NEW SMART STENT (7X120MM) AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) THERE WAS EXCESS FORCE USED DURING PREP. THERE WAS NO DAMAGES NOTED TO THE DEVICE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THE PRODUCT WAS NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317036 ↗
• InjuryAug 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A SMART STENT IN THE TARGET LESION WITHOUT ANY ISSUE. THE PATIENT WAS A (B)(6) FEMALE. THE PATIENT¿S WEIGHT WAS (B)(6). THE ORIGINAL TARGET LESION WAS THE MIDDLE PORTION OF THE RIGHT FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. APPROXIMATELY 3 YEARS AFTER THE INDEX PROCEDURE, THE PATIENT HAD PAIN. A MONTH LATER THE PATIENT UNDERWENT A RADIOGRAPHY WHICH CONFIRMED THAT THE LESION HAD RESIDUAL STENOSIS. THEREFORE THE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND AN UNKNOWN STENT WAS IMPLANTED IN THE ENTRY OF THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT RECOVERED.

  Patient problems: Reocclusion; Vascular System (Circulation), Impaired

  MAUDE report 6774421 ↗
• InjuryMay 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE JAPAN SMART PMS STUDY, A SMART STENT WAS PLACED IN THE DISTAL PORTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY OF A (B)(6) MALE PATIENT ON (B)(6) 2013. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS MILDLY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. ON (B)(6) 2014: IN STENT RESTENOSIS OF 75 % IN THE STENT AT THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS CONFIRMED, AND REVASCULARIZATION (PLAIN OLD BALLOON ANGIOPLASTY POBA) WAS PERFORMED. THE PATIENT RECOVERED AND LEFT THE HOSPITAL. ON (B)(6) 2014: IN STENT RESTENOSIS OF 75 % WAS CONFIRMED IN THE RIGHT EXTERNAL ILIAC ARTERY, THE RIGHT COMMON FEMORAL ARTERY AND THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE MIDDLE PORTION OF THE LEFT ANTERIOR DESCENDING ARTERY AND THE PROXIMAL PORTION TO THE DISTAL PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS HOSPITALIZED AND POBA WAS PERFORMED. THE PATIENT RECOVERED AND LEFT THE HOSPITAL. ON (B)(6) 2015: THE PATIENT WAS HOSPITALIZED. AN ANGIOGRAPHY WAS TAKEN. IN STENT RESTENOSIS OF 90 % WAS CONFIRMED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. THE PATIENT RECOVERED AND LEFT THE HOSPITAL. TH

  Patient problems: Stenosis

  MAUDE report 6566617 ↗
• DeathMay 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT EXPIRED APPROXIMATELY TWO YEARS AFTER A SMART STENT HAD BEEN IMPLANTED WITHOUT ANY ISSUE. THE CAUSE OF DEATH WAS ATTRIBUTED TO ARTERIOSCLEROSIS OBLITERANS. THE PATIENT WAS A (B)(6) MALE. THE TARGET LESION WAS THE PROXIMAL PORTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL WAS MODERATELY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. APPROXIMATELY TWO YEARS AFTER THE STENT HAD BEEN IMPLANTED, THE PATIENT VISITED THE HOSPITAL AND A CHRONIC TOTAL OCCLUSION (CTO) OF AN IN-STENT RESTENOSIS (ISR) OF THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS CONFIRMED. THE PATIENT WAS HOSPITALIZED AND BOTH A CORONARY ANGIOGRAPHY AND AN AORTOGRAPHY (AOG) FOR THE LOWER EXTREMITIES WERE PERFORMED. THE PATIENT UNDERWENT A PLAIN OLD BALLOON ANGIOPLASTY (POBA) PROCEDURE FOR REVASCULARIZATION OF THE CTO AND ISR. DURING THE POBA, THERE WAS DIFFICULTY CROSSING THE LESION. AN ADDITIONAL RETROGRADE PUNCTURE WAS MADE FROM THE DISTAL PART OF THE LESION IN ORDER TO CROSS. A THROMBUS ASPIRATION WAS DONE. AFTERWARDS, BLOOD FLOW WAS VERIFIED AND HEMOSTASIS WAS ACHIEVED. THERE WAS NO UNUSUAL HEMORRHAGE CONFIRMED DURING OR AFTER THE PROCEDURE. THE PROCEDURE LASTED APPROXIMATELY 6 HOU

  Patient problems: Cardiogenic Shock; Death; Hemorrhage/Blood Loss/Bleeding; Reocclusion; Vascular System (Circulation), Impaired

  MAUDE report 6546098 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IN-STENT RE-STENOSIS WITH TWO SMART STENTS AND A SMART CONTROL STENT. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR THE EDGES OF THE LESION, INSIDE THE IN-STENT RE-STENOSIS, AND WHOLE LESION. THE PATIENT RECOVERED. TWO SMART STENTS AND A SMART CONTROL STENT WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE ON (B)(6) 2013. THREE YEARS LATER ((B)(6) 2016), INTERMITTENT CLAUDICATION WAS CONFIRMED ON THE PATIENT. THE PATIENT HAD AN ANGIOGRAPHY EXAMINATION ON (B)(6) 2016, AND PPI WAS PERFORMED. THE RATE OF ABI BEFORE PPI WAS 0.96 IN THE RIGHT AND 0.48 IN THE LEFT. THE RATE OF STENOSIS BEFORE PPI WAS 50 TO 99 % OF STENOSIS. THE TARGET LESION WAS THE DISTAL, MIDDLE, AND PROXIMAL PORTIONS OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100%. THIS IS A CASE FROM (B)(6) SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(4).

  Patient problems: Reocclusion

  MAUDE report 6087653 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IN-STENT RE-STENOSIS WITH TWO SMART STENTS AND A SMART CONTROL STENT. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR THE EDGES OF THE LESION, INSIDE THE IN-STENT RE-STENOSIS, AND WHOLE LESION. THE PATIENT RECOVERED. TWO SMART STENTS AND A SMART CONTROL STENT WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE ON (B)(6) 2013. THREE YEARS LATER ((B)(6) 2016), INTERMITTENT CLAUDICATION WAS CONFIRMED ON THE PATIENT. THE PATIENT HAD AN ANGIOGRAPHY EXAMINATION ON (B)(6) 2016, AND PPI WAS PERFORMED. THE RATE OF ABI BEFORE PPI WAS 0.96 IN THE RIGHT AND 0.48 IN THE LEFT. THE RATE OF STENOSIS BEFORE PPI WAS 50 TO 99 % OF STENOSIS. THE TARGET LESION WAS THE DISTAL, MIDDLE, AND PROXIMAL PORTIONS OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100%. THIS IS A CASE FROM (B)(6) SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(4).

  Patient problems: Reocclusion

  MAUDE report 6087627 ↗
• MalfunctionOct 15, 2016Premature Activation; Premature Activation

  AS REPORTED, DURING A SUPERFICIAL FEMORAL ARTERY (SFA) STENTING PROCEDURE WITH AN INITIAL NON-CORDIS STENT PLACED AT THE OSTIUM, A SMART 120 150 SFA 7 X 150 MM. AND A SMART CONTROL ILIAC 6 X 40ML. APPEARED TO GET HUNG UP ON THE NON-CORDIS STENT AND UNSHEATH DURING ADVANCEMENT. AFTER SEVERAL ATTEMPTS THEY WERE REMOVED AND STILL INTACT. OTHER SMART STENTS WERE USED AND THE OUTCOME WAS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6032174 ↗
• MalfunctionAug 25, 2016Fracture; Fracture

  AS REPORTED, THE PATIENT WAS ENROLLED IN A CLINICAL STUDY (B)(6) AND THE CASE NUMBER IS (B)(4). THE PATIENT HAD A 120/150 SMART SFA 7 X 150 STENT IMPLANTED SUCCESSFULLY DURING THE STUDY INDEX PROCEDURE WITH NO REPORTED ISSUE. THE TARGET LESION WAS THE MIDDLE PORTION OF THE LEFT FEMORAL ARTERY. THE RATE OF STENOSIS WAS UNKNOWN. NO ADDITIONAL TARGET LESION CHARACTERISTIC INFORMATION WAS PROVIDED. APPROXIMATELY THIRTY-FIVE MONTHS AFTER THE INDEX PROCEDURE, A SLIGHT FRACTURE (FRACTURE TYPE 1) OF THE MIDDLE PART OF THE STENT WAS NOTED DURING AN X-RAY CHECKUP. NO TREATMENT WAS APPLIED/PROVIDED. THE PATIENT HAS NOT BEEN RECOVERED. IT WAS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC AS A RESULT OF THE REPORTED PRODUCT ISSUE/STENT FRACTURE NOTED. THERE WAS NO REPORTED RESTENOSIS OF THE STENT NOTED. NO OTHER FOLLOW-UP IS SCHEDULED FOR THE PATIENT AS A RESULT OF THE REPORTED PRODUCT ISSUE. THE FOLLOWING INFORMATION WAS REQUESTED BUT WAS REPORTED TO BE UNKNOWN: IS THERE ANY ADDITIONAL TARGET LESION CHARACTERISTIC INFORMATION AVAILABLE; WHAT IS THE PATIENT'S MEDICAL HISTORY; WHAT WAS THE PATIENT'S MEDICAL REGIMEN POST-PROCEDURE; WAS THE PATIENT COMPLIANT WITH THE MEDICAL REGIMEN. NO ADDITIONAL INFORM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5903688 ↗