Cordis S.M.A.R.T. Vascular Stent System C06150MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 20705032063408), received between Aug 31, 2016 and Jul 15, 2022 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2022Crack; Crack

  AS REPORTED, WHILE ATTEMPTING TO CROSS A LONG CALCIFIED CTO IN THE POPLITEAL ARTERY WITH THE SMART 6X150MM, THE END OF THE STENT DELIVERY SHAFT (TIP) BECAME DEFORMED AND THE DEVICE WOULD NOT CROSS THE LESION. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE BODY AND A CRACK WAS NOTED TO THE END OF THE DEVICE TIP. AN UNKNOWN 5.0 BALLOON WAS PASSED THROUGH THE LESION AND PTA WAS PERFORMED. A NEW 6.0X150 SMART STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION AND THE CASE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO DIFFICULTY NOTED WHILE REMOVING THE PRODUCT FROM THE PACKAGING OR WHILE REMOVING FROM THE HOOP. THERE WAS NO DIFFICULTY NOTED WHILE REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU WITHOUT DIFFICULTY. A 6F CORDIS AVANTI + SHEATH WAS USED FOR THE PROCEDURE. THE LESION WAS PRE-DILATED WITH A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15027917 ↗
• MalfunctionNov 16, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE DOCTOR ADVANCED A 6MM X 150MM X 120CM SMART SUPERFICIAL ARTERY (SFA) SELF-EXPANDING STENT (SES) DELIVERY SYSTEM TO THE PERIPHERY OF THE SFA, LOOSENED THE VALVE LOCK AND PULLED THE OUTER SHEATH TO TRY TO BE DEPLOYED; HOWEVER, THE DOCTOR FELT RESISTANCE AND ANOMALY ON THE DEVICE. THEREFORE, IT WAS REMOVED FROM THE PATIENT¿S BODY AND CONFIRMED OUTSIDE THE BODY THAT A PART OF THE STENT HAD BEEN DEPLOYED. THERE WAS A RESISTANCE THAT THE DOCTOR DOESN¿T NORMALLY FEEL. SO, THE DEVICE WAS REPLACED WITH THE SAME SIZE SMART STENT AND IT COULD BE IMPLANTED. AFTER THAT, ADDITIONAL TWO UNKNOWN STENTS (7 X 150 AND 7 X 120) WERE IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT SFA. THE LESION HAD A CHRONIC TOTAL OCCLUSION (CTO) FROM PROXIMAL TO DISTAL (30CM). AN APPROACH WAS MADE FROM THE COMMON FEMORAL ARTERY. A 6F 445CM NON-CORDIS GUIDING SHEATH WAS USED. A CONTRALATERAL CROSS-OVER APPROACH WAS MADE WITH A 6F BRITE TIP GUIDING CATHETER AND AN UNKNOWN WIRE CROSSED THE LESION. AN UNKNOWN 5MM BALLOON CATHETER WAS INFLATED AS PRE-DILATION. THERE WERE NO COMPLICATIONS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10846994 ↗
• MalfunctionFeb 4, 2020Crack; Crack

  DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE 6MM X120CM SMART SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS CONFIRMED THAT THE DISTAL END OF THE TIP WAS CRACKED. THE FIRST NON-CORDIS GUIDEWIRE WAS USED AS A DELIVERY WIRE BUT IT GOT STUCK AFTER REMOVING THE GUIDING CATHETER OF THE SMART STENT AND IT WAS CONFIRMED THAT THERE WAS NO ANOMALY FOR THE DELIVERY SYSTEM. IT WAS CHANGED TO A NEW NON-CORDIS GUIDEWIRE, BUT THE SECOND GUIDEWIRE WAS STUCK IN FRONT OF THE LESION. THEREFORE, THE SMART STENT WAS REMOVED AGAIN, AND THE PROCEDURE WAS COMPLETED WITH THE USE OF A NON-CORDIS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. A CROSS-OVER APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY (RFA). THE LESION WAS A DISTAL PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS DETERMINED THAT A STENT WAS NECESSARY BECAUSE OF THE STRONG CALCIFICATION. A DEVICE WAS FLUSHED AS PER THE INSTRUCTION PER USE (IFU). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS SINCE IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9665087 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) STUDY, APPROXIMATELY 5 YEARS AFTER TWO 6X150MM SMART STENTS WERE IMPLANTED IN THE PROXIMAL TO THE DISTAL PORTION OF THE LEFT FEMORAL ARTERY, STENT THROMBOSIS WAS CONFIRMED. THE LEVEL OF ABI WAS 0.34 ON THE LEFT AND PULSE OF THE LEFT POPLITEAL ARTERY WAS WEAK. SLIGHT CLAUDICATION WAS CONFIRMED AS WELL. THEREFORE, IT WAS DIAGNOSED AS IN STENT RESTENOSIS ON THE LEFT SUPERFICIAL FEMORAL ARTERY. THERE WAS NO TREATMENT PROVIDED. ON THE SAME DAY, THE PATIENT RECOVERED. THE EVENT WAS CONSIDERED SERIOUS, NOT RELATED TO THE STUDY DEVICES AND THE REASON OF ITS RELEVANCY JUDGMENT WAS THE PRIMARY DISEASE. AT STUDY INCLUSION, THE 100% OCCLUDED TARGET LESION WAS 280MM IN LENGTH IN A 5.6MM VESSEL DIAMETER. THE LESION WAS A LITTLE CALCIFIED AND THE VESSEL WAS ALSO A LITTLE TORTUOUS. THROMBUS WAS PRESENT AT THE PROXIMAL, MIDDLE AND DISTAL PORTION. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED WITH A 4MMX100MM BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS 100% STENOSIS PRESENT AFTER PRE-DILATATION. THE LESION WAS POST-DILATED AFTER STENT IMPLANTATION. ANTI-PLATELET THERAPY WAS PRESCRIBED BEFORE, DURING AND AFTER THE PROCEDURE BUT THE DETAILS WERE UNKNOWN.

  Patient problems: Reocclusion; Thrombosis

  MAUDE report 7898030 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(4) STUDY, APPROXIMATELY 5 YEARS AFTER TWO 6X150MM SMART STENTS WERE IMPLANTED IN THE PROXIMAL TO THE DISTAL PORTION OF THE LEFT FEMORAL ARTERY, STENT THROMBOSIS WAS CONFIRMED. THE LEVEL OF ABI WAS 0.34 ON THE LEFT AND PULSE OF THE LEFT POPLITEAL ARTERY WAS WEAK. SLIGHT CLAUDICATION WAS CONFIRMED AS WELL. THEREFORE, IT WAS DIAGNOSED AS IN STENT RESTENOSIS ON THE LEFT SUPERFICIAL FEMORAL ARTERY. THERE WAS NO TREATMENT PROVIDED. ON THE SAME DAY, THE PATIENT RECOVERED. THE EVENT WAS CONSIDERED SERIOUS, NOT RELATED TO THE STUDY DEVICES AND THE REASON OF ITS RELEVANCY JUDGMENT WAS THE PRIMARY DISEASE. AT STUDY INCLUSION, THE 100% OCCLUDED TARGET LESION WAS 280MM IN LENGTH IN A 5.6MM VESSEL DIAMETER. THE LESION WAS A LITTLE CALCIFIED AND THE VESSEL WAS ALSO A LITTLE TORTUOUS. THROMBUS WAS PRESENT AT THE PROXIMAL, MIDDLE AND DISTAL PORTION. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED WITH A 4MMX100MM BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS 100% STENOSIS PRESENT AFTER PRE-DILATATION. THE LESION WAS POST-DILATED AFTER STENT IMPLANTATION. ANTI-PLATELET THERAPY WAS PRESCRIBED BEFORE, DURING AND AFTER THE PROCEDURE BUT THE DETAILS WERE UNKNOWN.

  Patient problems: Reocclusion; Thrombosis

  MAUDE report 7897766 ↗
• MalfunctionFeb 27, 2018Difficult or Delayed Positioning; Difficult To Position; Difficult or Delayed Positioning; Difficult To Position

  DURING USE, IT WAS REPORTED THAT THE SMART STENT FAILED TO CROSS THE LESION AFTER THREE ATTEMPTS, THE STENT WAS REMOVED AND IT WAS NOTICED THAT THE STENT WAS SLIGHTLY EXPOSED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH BALLOON DILATATIONS AND NO DISSOCIATION WAS CONFIRMED. THE PROCEDURE COMPLETED SUCCESSFULLY. A CONTRALATERAL APPROACH WAS MADE FROM THE LEFT COMMON FEMORAL ARTERY. AN UNKNOWN GUIDEWIRE (014) CROSSED THE LESION AND AN UNKNOWN BALLOON CATHETER (3.0*40) WAS INFLATED AS A PRE DILATATION. THEN A SMART STENT WAS INSERTED BUT COULD NOT CROSS THE LESION. SO ANOTHER PRE DILATATION WAS PERFORMED WITH THE SAME BALLOON CATHETER AND THE SMART STENT ATTEMPTED TO CROSS THE LESION. HOWEVER IT COULD NOT CROSS THE LESION. ANOTHER UNKNOWN BALLOON CATHETER (4.0*40) WAS INFLATED, BUT THE SMART STENT COULD NOT CROSS. THEREFORE IT WAS REMOVED FROM THE PATIENT AND IT WAS CONFIRMED THAT THERE WAS A GAP BETWEEN THE DISTAL TIP AND THE OUTER SHEATH, AND THE STENT WAS SLIGHTLY EXPOSED. THE TARGET LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299336 ↗
• InjuryDec 6, 2017Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE SMART PMS FOR SFA STUDY, FOUR YEARS POST IMPLANTATION OF A THREE SMART (SMART 120 150, SFA - 6 X 150 MM / SMART CONTROL, ILIAC 8 X 60 ML) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT WAS HOSPITALIZED DUE TO IN-STENT RESTENOSIS AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR TARGET LESION REVASCULARIZATION. THE TOTAL LENGTH OF THE STENTED SEGMENT IS 360 MM (150+150+60). THERE WERE THREE (3) STENTS PLACED. THE RESTENOSIS WAS LOCATED INSIDE AND ON THE EDGE OF THE STENT. A NON-CORDIS STENT GRAFT WAS IMPLANTED. THE TARGET LESION WAS IN-STENTS AND THE EDGE OF THE STENTS. THE PATIENT RECOVERED. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT.

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

  MAUDE report 7088577 ↗
• InjuryDec 6, 2017Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE SMART PMS FOR SFA STUDY, FOUR YEARS POST IMPLANTATION OF A THREE SMART (SMART 120 150, SFA - 6 X 150 MM / SMART CONTROL, ILIAC 8 X 60 ML) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT WAS HOSPITALIZED DUE TO IN-STENT RESTENOSIS AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR TARGET LESION REVASCULARIZATION. THE TOTAL LENGTH OF THE STENTED SEGMENT IS 360 MM (150+150+60). THERE WERE THREE (3) STENTS PLACED. THE RESTENOSIS WAS LOCATED INSIDE AND ON THE EDGE OF THE STENT. A NON-CORDIS STENT GRAFT WAS IMPLANTED. THE TARGET LESION WAS IN-STENTS AND THE EDGE OF THE STENTS. THE PATIENT RECOVERED. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT.

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

  MAUDE report 7088315 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(4) STUDY, A SMART 120 150, SUPERFICIAL FEMORAL ARTERY (SFA) - 6 X 150 MM STENT AND A SMART CONTROL, ILIAC 6 X 60 ML STENT WERE IMPLANTED IN THE TARGET LESION WITHOUT ANY ISSUE. APPROXIMATELY 4 YEARS, 2 MONTHS POST INDEX PROCEDURE, THE PATIENT DEVELOPED ASYMPTOMATIC STENT THROMBOSIS. ABI AND DUS CONFIRMED THE OCCLUSION. THE THROMBOSIS WAS INSIDE AND THE EDGE OF THE STENT(S). RUTHERFORD EXAM WAS NOT DONE, AND NO TREATMENT WAS APPLIED. THE PATIENT WAS A (B)(6)-YEARS-OLD FEMALE. THE TARGET LESION WAS THE MIDDLE PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS MILDLY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN.

  Patient problems: Thrombosis

  MAUDE report 7084014 ↗
• MalfunctionNov 8, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 6 X 150 MM SMART 120 150 SUPERFICIAL FEMORAL ARTERY (SFA) STENT WOULD NOT FULLY DEPLOY/UN-SHEATH. THE STENT WAS SAID TO FLOWER UP AT THE TOP BUT WOULD NOT FULLY DEPLOY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE RATE OF STENOSIS WAS 70%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE TARGET LESION WAS 1MM LESS THAN THE STENT SIZE. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THE DEVICE WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DIAMETER OF THE UNCONSTRAINED STENT WAS SIZED 1-2 MM LARGER THAN THE VESSEL DIAMETER. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU AND PREPPED NORMALLY. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE DEVICE TOWARDS THE LESION. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE OPERATOR WAS UNABLE TO UNSHEATHE THE STENT AT ALL. THERE WAS NO UNUSUAL F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7012206 ↗
• MalfunctionAug 16, 2017Fracture; Fracture

  AS REPORTED BY THE (B)(6) FOR SFA STUDY, APPROXIMATELY TWENTY-FIVE MONTHS ((B)(6) 2015) POST IMPLANTATION OF THE SMART (120 150, SFA - 6X150MM) SELF¿EXPANDING STENT (SES) ON THE PROXIMAL TO THE DISTAL PORTION OF THE RIGHT FEMORAL ARTERY, AN X-RAY PHOTO SHOWED BREAKAGE OF THE SMART (120 150, SFA - 6X150MM) STENT, IT WAS A TYPE II STENT FRACTURE. HOWEVER, THERE WAS NO CLINICAL SYMPTOM REPORTED. THERE WAS NO TREATMENT APPLIED TO THE PATIENT AND THE PATIENT DID NOT RECOVERED. LATER, THREE YEARS POST STENT IMPLANTATION DURING PATIENT VISIT IT SHOWED THAT NO CHANGE WAS CONFIRMED ON THE STENT AND THE PATIENT. THERE WAS NO X-RAY PHOTO TAKEN AT THIS TIME. THEN, FOUR YEARS POST STENT IMPLANTATION DURING ANOTHER PATIENT VISIT IT SHOWED THAT NO CHANGE WAS CONFIRMED ON THE STENT AND THE PATIENT. THERE WAS X-RAY PHOTO TAKEN AT THIS TIME. IT WAS REPORTED THAT THE EVENT IS RELATED TO THE PRODUCT AND TO THE PROCEDURE. ON (B)(6) 2013, THE SMART STENT WAS DEPLOYED IN THE TARGET LESION WITHOUT ANY ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798526 ↗
• InjuryAug 7, 2017Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE SMART PMS FOR SFA STUDY, APPROXIMATELY THIRTEEN MONTHS ((B)(6) 2017) POST IMPLANTATION OF THE SMART (120 150, SFA - 6X150MM) SELF¿EXPANDING STENT (SES) ON THE LEFT SUPERFICIAL FEMORAL ARTERY, THE CONDITION OF THE LESION WITH THE STENT HAD BEEN WORSE, AND THE PEAK SYSTOLIC VELOCITY RATIO (PSVR) INCREASED TO 5.26. INTERMITTENT CLAUDICATION ON THE LEFT LEG WAS CONFIRMED. THEREFORE A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. IT WAS REPORTED THAT THERE WAS NO RELEVANCY TO THE PRODUCT OR THE PROCEDURE. ON THE SAME DAY, THE PATIENT RECOVERED. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS MILDLY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN.

  Patient problems: Reocclusion

  MAUDE report 6772218 ↗
• MalfunctionJan 10, 2017Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  AS REPORTED, THERE WAS A STRONG RESISTANCE FELT WHEN ATTEMPTING TO DEPLOY A 6X150MM SMART STENT. IT WAS REPLACED WITH A NEW SMART STENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.  THE DEVICE WAS RECEIVED BY THE DECONTAMINATION SITE WITH STENT DEPLOYED 2.5CM AND KINK AT 2CM FROM STRAIN. IT WAS UNKNOWN IF THE DEVICE DEPLOYED OUTSIDE THE PATIENT AFTER THE PROCEDURE. IT IS UNKNOWN IF THE DEVICE WAS CONFIRMED TO BE COMPLETELY CONSTRAINED IN THE OUTER SHEATH AFTER REMOVAL FROM THE PATIENT. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THERE WERE NO DAMAGES OR ANOMALIES NOTED TO THE SMART STENT DELIVERY SYSTEM PRIOR TO REMOVAL FROM PACKAGING, AND NO DAMAGES OR ANOMALIES NOTED TO THE PACKAGING PRIOR TO OPENING. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING, AND THE PRODUCT WAS STORED, INSPECTED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  AN UNKNOWN APPROACH WAS MADE AT AN UNKNOWN ACCESS SITE LOCATION. A 6F NON-CORDIS SHEATH INTRODUCER WAS INSERTED. A NON-CORDIS GUIDE WIRE CROSSED TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6236856 ↗
• InjuryNov 22, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT RESTENOSIS WAS CONFIRMED IN A PATIENT WHO HAD TWO SMART STENTS AND A SMART CONTROL STENT PREVIOUSLY PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. AFTER THE RESTENOSIS WAS CONFIRMED, A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED A MONTH LATER. THE PATIENT RECOVERED. THE TARGET LESION WAS THE PROXIMAL PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL WAS NOT CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 100%. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: Reocclusion

  MAUDE report 6120183 ↗
• InjuryNov 21, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT RESTENOSIS WAS CONFIRMED IN A PATIENT WHO HAD TWO SMART STENTS AND A SMART CONTROL STENT PREVIOUSLY PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. AFTER THE RESTENOSIS WAS CONFIRMED, A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED A MONTH LATER. THE PATIENT RECOVERED. THE TARGET LESION WAS THE PROXIMAL PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT¿S VESSEL WAS NOT CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 100%. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: Reocclusion

  MAUDE report 6118649 ↗
• InjuryOct 5, 2016Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE JAPAN SMART PMS FOR SFA, AFTER AN UNSPECIFIED TIME WHEN A 120 150, SFA - 6X150MM SMART STENT AND A 6X100 SMART CONTROL ILIAC STENT WERE PLACED IN THE MIDDLE PORTION TO THE DISTAL PORTION OF THE FEMORAL ARTERY WITH UNKNOWN STENOSIS OF A (B)(6) MALE PATIENT WITH UNKNOWN MEDICAL HISTORY, THE PERIODIC SURVEY REPORTED THAT THE FOLLOWING ITEMS WERE ENTERED AS "OCCLUSION" ON THE LIST; PATENCY, DUS, THE PROXIMAL PORTION OF STENOSIS PSV, AND THE MAXIMUM PSV OF STENOSIS. THE PATIENT IS NOW UNDER OBSERVATION, AND NO TREATMENT WAS APPLIED." ADDITIONAL INFORMATION WAS RECEIVED THAT DUS MEANS DOPPLER ULTRA SOUND. IT NOT KNOWN WHICH STENT WAS PATENT BUT BOTH STENTS HAD PSV. IT IS UNKNOWN IF THE ORIGINAL LESION WAS CALCIFIED OR THE VESSEL TORTUOUS, IF THE STENTS WERE OVERLAPPING, IF THE STENTS WERE DEPLOYED WITH GOOD WALL APPOSITION AND IF IVUS WAS DONE POST PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Reocclusion

  MAUDE report 6000464 ↗
• InjuryAug 31, 2016Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY THE JAPAN SMART PMS FOR SFA, AFTER AN UNSPECIFIED TIME WHEN A 120 150, SFA - 6X150MM SMART STENT AND A 6X100 SMART CONTROL ILIAC STENT WERE PLACED IN THE MIDDLE PORTION TO THE DISTAL PORTION OF THE FEMORAL ARTERY WITH UNKNOWN STENOSIS, THE PERIODIC SURVEY REPORTED THAT THE FOLLOWING ITEMS WERE ENTERED AS "OCCLUSION" ON THE LIST; PATENCY, DUS, THE PROXIMAL PORTION OF STENOSIS PSV, AND THE MAXIMUM PSV OF STENOSIS. THE PATIENT IS NOW UNDER OBSERVATION, AND NO TREATMENT WAS APPLIED."

  Patient problems: Reocclusion

  MAUDE report 5919399 ↗