Cordis S.M.A.R.T. Vascular Stent SystemRecalls & reported problems across all models

We found 3 models of Cordis S.M.A.R.T. Vascular Stent System by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Aug 31, 2016 and Mar 15, 2023 — classified as 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

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

Cordis S.M.A.R.T. Vascular Stent System models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cordis S.M.A.R.T. Vascular Stent System C06150ML

  STENT, SUPERFICIAL FEMORAL ARTERY
  17 reports
• Cordis S.M.A.R.T. Vascular Stent System C08150ML

  STENT, SUPERFICIAL FEMORAL ARTERY
  6 reports
• Cordis S.M.A.R.T. Vascular Stent System C08120ML

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports

Recent Cordis S.M.A.R.T. Vascular Stent System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE DISTAL TIP OF AN 8MM X 150MM SMART SES (SELF-EXPANDING STENT) DELIVERY SYSTEM WAS INSERTED AND GOT FRAYED WHEN DELIVERED TO THE LESION. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER SMART STENT. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS INFLATED WITH BALLOON CATHETERS. THE TARGET LESION WAS THE ILIAC. ACCESS VESSEL CHARACTERISTICS INCLUDED MILD CALCIFICATION AND TORTUOSITY IN ADDITION TO NINETY PERCENT STENOSIS. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS NOT CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH WHEN IT WAS REMOVED FROM THE TRAY. THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE STOPCOCK OR FLUSHING THE SDS. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. THE DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE SDS DID NOT PASS THROUGH A PREVIOUSLY PLACED STENT. THE DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546672 ↗
• 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 ↗
• MalfunctionFeb 9, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE OUTER SHEATH OF AN 8MM X 150MM 120CM S.M.A.R.T. SFA SELF-EXPANDING STENT (SES) WAS UNABLE TO MOVE. AS A RESULT, THE S.M.A.R.T. STENT WAS UNABLE TO BE DEPLOYED. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AND THE DEVICE WILL BE RETURNED FOR EVALUATION. PER VISUAL ANALYSIS, THE STENT OF THE UNIT WAS OBSERVED DEPLOYED APPROXIMATELY 5 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498478 ↗
• MalfunctionMay 10, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 8MM X 150MM X 120CM SUPERFICIAL FEMORAL ARTERY (SFA) SMART SELF-EXPANDING STENT (SES) SYSTEM WAS BEING DELIVERED BUT APPROXIMATE 2 STRUTS FROM THE DISTAL END, THE STENT BEGAN TO DEPLOY ALREADY, AND IT WAS NOT ABLE TO OVERLAP THE FORMER SMART STENT (7.0MM*150MM). THE SMART STENT 8MM X 150MM X 120CM WAS REPLACED WITH ANOTHER SMART STENT (8.0MM*120MM) AND IT WAS IMPLANTED. POST-DILATION WAS DONE WITH A SABER RAPID EXCHANGE (RX) BALLOON CATHETER (5.0MM*250MM) AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY WHICH HAD CHRONIC TOTAL OCCLUSION (CTO). AN APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A CROSS-OVER ANTEGRADE APPROACH WAS MADE WITH A GUIDING SHEATH (6F NON-CORDIS). A GUIDEWIRE (UNKNOWN) CROSSED THE LESION. PRE-DILATION WAS DONE WITH TWO SABER RX BALLOON CATHETERS (4.0MM*250MM AND 5.0MM*250MM). THE SMART STENT (7.0MM*150MM) WAS IMPLANTED AT THE DISTAL SUPERFICIAL FEMORAL ARTERY. THE SMART STENT (8.0MM*120MM) WAS USED FOR IMPLANTATION AT THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802412 ↗
• 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 ↗
• MalfunctionApr 1, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AFTER A WIRE CROSSED THE LESION, THE 8MM X 150MM SMART CONTROL SELF EXPANDING STENT (SES) WAS INSERTED HOWEVER, IT WAS DIFFICULT TO DELIVER TO THE LESION. THEREFORE, IT WAS REMOVED FROM THE PATIENT¿S BODY AND THE PHYSICIAN FOUND OUT THAT THE DISTAL END OF THE TIP WAS FRAYED. THE DEVICE WAS REPLACED WITH A NEW SMART STENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913592 ↗
• 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 ↗
• MalfunctionFeb 21, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 8X120MM SMART STENT COULD NOT CROSS THE LESION. SO, IT WAS REMOVED FROM THE PATIENT. THERE WAS A GAP BETWEEN THE DISTAL TIP AND THE OUTER SHEATH. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. AN APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY. A NON-CORDIS BALLOON CATHETER WAS INFLATED AS A PRE-DILATION. AFTER THE SMART STENT FAILED TO CROSS THE LESION AND REMOVED FROM THE PATIENT, THE BALLOON CATHETER WAS INFLATED AND TRIED AGAIN. HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN TRIED TO CROSS THE STENT AFTER ANOTHER NON-CORDIS BALLOON CATHETER WAS INFLATED BUT THE SAME ISSUE OCCURRED AGAIN. THE STENT WAS REPLACED WITH A NEW NON-CORDIS STENT AND IMPLANTED DUE TO THE SMART STENT HAVING A GAP BETWEEN THE DISTAL TIP AND THE OUTER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358658 ↗
• 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 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(4) STUDY, APPROXIMATELY THIRTY-NINE MONTHS POST IMPLANTATION OF THREE SMART (SMART 120 150, SFA - 7X120MM, 8X120MM, SMART CONTROL, ILIAC 8X100ML) SELF¿EXPANDING STENTS (SES) ON THE SUPERFICIAL FEMORAL ARTERY, THE PATIENT HAD INTERMITTENT CLAUDICATION APPEARED AND ALSO A RIGHT SUPERFICIAL FEMORAL ARTERY OCCLUSION AND STENOSIS OF THE RIGHT COMMON FEMORAL ARTERY ORIGIN WAS CONFIRMED BY DOPPLER ULTRASOUND (DUS). A TREATMENT PLAN WAS GOING TO BE DETERMINED THE NEXT TIME THE PATIENT VISITS THE HOSPITAL. NONE OF THESE EVENTS WERE RELEVANT TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT.

  Patient problems: Claudication; Occlusion; Stenosis

  MAUDE report 7067898 ↗

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