SUPERA S-60-100-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648211829), received between Aug 30, 2016 and Jun 17, 2025 — classified as 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS PREPARED USING A 6X100MM BALLOON AND ATHERECTOMY. THE 6.0X100MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION AND THE STENT DEPLOYED. DURING REMOVAL THE TIP OF THE SES SEPARATED AND BECAME STUCK IN THE SHEATH. THE SES WAS SUCCESSFULLY REMOVED HOWEVER THE PATIENT WAS SENT FOR SURGICAL REMOVAL OF THE SHEATH AND SEPARATED TIP, REQUIRING ADDITIONAL HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22232585 ↗
• InjuryMay 22, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, DURING DEPLOYMENT OF THE SUPERA SES, THE SYSTEM LOCK AND DEPLOYMENT LOCK WERE NOT ROTATED INTO THE LOCK POSITION AND THE STENT APPEARED TO NOT BE COMPLETELY DEPLOYED WHEN PULLED BACK INTO THE SHEATH. THE STENT WAS CONFIRMED TO BE IMPLANTED AT THE LESION. WHEN ATTEMPTING TO REMOVE THE SUPERA DELIVERY SYSTEM, RESISTANCE WAS NOTED AT THE DISTAL SHEATH AND FORCE WAS APPLIED. THE TIP OF THE DELIVERY SYSTEM SEPARATED AND AN ATTEMPT WAS MADE TO SNARE OUT THE SEPARATED TIP, HOWEVER THE TIP WAS EMBEDDED IN A PREVIOUSLY OCCLUDED PERONEAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072547 ↗
• InjuryApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X100MM SUPERA SELF-EXPANDING STENT WAS IMPLANTED; HOWEVER, DURING REMOVAL OF THE SUPERA DELIVERY SYSTEM TIP OF THE NOSE CONE SEPARATED AND THE STENT FRACTURED. A PORTION OF THE STENT MIGRATED DOWNSTREAM AND OCCLUDED A VESSEL. A CUT DOWN WAS PERFORMED TO REMOVE THE TIP ALONG WITH THE PROXIMAL PORTION OF THE STENT. THE REMAINING PIECE OF THE SUPERA REMAINED IMPLANTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 21910823 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION, A 6.0X100 SUPERA PERIPHERAL STENT SYSTEM PACKAGE WAS OPENED AND THE TIP OF THE STENT DELIVERY SYSTEM WAS OBSERVED TO BE SEPARATED INTO TWO PIECES. ANOTHER SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753473 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN (B)(6) 2024. THE SUPERA STENT WAS IMPLANTED TO TREAT A 60% STENOSED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH CALCIFICATION. ON (B)(6) 2024, IN STENT RESTENOSIS WAS NOTED AND THE STENT WAS FOUND TO BE 60% OCCLUDED; THEREFORE, THE PATIENT WAS TREATED WITH SHOCKWAVE LITHOTRIPSY AND LASER ATHERECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20570883 ↗
• InjuryMay 17, 2024Material Separation; Migration; Material Separation; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH NO TORTUOSITY, CALCIFICATION AND 50% STENOSIS. ACCESS IN THE RIGHT GROIN WAS OBTAINED USING A 6FR SHEATH, A NON-ABBOTT 0.18 GUIDE WIRE AND NON-ABBOTT SUPPORT CATHETER. ADDITIONAL ACCESS WAS OBTAINED IN THE LEFT FOOT FOR ADVANCING A NON-ABBOTT 0.018 GUIDE WIRE. THE VESSEL WAS PRE-DILATED WITH AN UNSPECIFIED 6X100MM BALLOON DEVICE. ADVANCING RETROGRADE, THE FIRST SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED. THE 6X100MM 120MM SUPERA STENT WAS THEN IMPLANTED IN THE TARGET LESION IN AN OVERLAPPING FASHION. AN UNSPECIFIED POST DILATION DEVICE WAS ADVANCED, AND THE SECOND STENT WAS NOTED TO HAVE SHIFTED; THEREFORE, A THIRD SUPERA STENT WAS IMPLANTED TO COVER THE GAP BETWEEN THE TWO PREVIOUS SUPERA STENTS. PRIOR TO REINSERTING THE DILATION DEVICE, THE DEVICE IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH NO TORTUOSITY, CALCIFICATION AND 50% STENOSIS. ACCESS IN THE RIGHT GROIN WAS OBTAINED USING A 6FR SHEATH, A NON-ABBOTT 0.18 GUIDE WIRE AND NON-ABBOTT SUPPORT CATHETER. ADDITIO

  Patient problems: Foreign Body In Patient

  MAUDE report 19346525 ↗
• InjuryAug 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE 6.0X100MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS IMPLANTED; HOWEVER, DURING REMOVAL OF THE SESS, THE NOSECONE SEPARATED. A SECOND STENT WAS USED AND CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17645901 ↗
• InjuryOct 19, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) VIA LEFT GROIN ACCESS WITH CALCIFICATION AND TORTUOSITY NOTED IN THE VESSEL. THE VESSEL WAS 6 MM, ATHERECTOMY WAS NOT USED AND THE VESSEL WAS PREPARED WITH A 6X200 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER TO 14 ATMOSPHERES AT 3 MINUTES. THE 6X100 MM SUPERA SELF EXPANDING STENT (SES) WAS THOUGHT TO HAVE BEEN SUCCESSFULLY DEPLOYED; HOWEVER, IT PARTIALLY DEPLOYED IN THE 6FR 45 CM SHEATH AND UPON REMOVAL THE TIP OF THE DELIVERY SYSTEM CAUGHT ON THE SHEATH. THE PHYSICIAN PULLED HARD WHEN SOME RESISTANCE WAS NOTED DURING REMOVAL AND THE TIP SEPARATED. TWO SNARES WERE ATTEMPTED AND OTHER BALLOON TECHNIQUES BUT THE TIP COULD NOT BE REMOVED. THE TIP WAS ABLE TO BE DRAGGED TO THE LEFT COMMON FEMORAL VIA THE LEFT GROIN ACCESS AND THE TIP WAS EMBEDDED TO THE VESSEL WITH AN ADDITIONAL STENT. THERE WAS A 2+ HOUR DELAY IN THE PROCEDURE AS A RESULT OF THE ADDITIONAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15633843 ↗
• InjuryJul 21, 2022Difficult to Remove; Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult to Remove; Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH A 6MM VESSEL DIAMETER. FOLLOWING PRE-DILATATION, THE 6.0X100MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT ISSUES AND THE STENT WAS FULLY DEPLOYED; HOWEVER, THE UNLOCK WAS NOT WORKING AND THE STENT WOULD NOT DETACH FROM THE DEVICE. THE SESS AND STENT WERE PULLED BACK UNDER FLUOROSCOPY, BUT RESISTANCE WITH THE ANATOMY WAS FELT. ADDITIONALLY, THE NOSE CONE SEPARATED AND THE STENT WAS DEPLOYED IN HEALTHY TISSUE. THE NOSE CONE WAS SUCCESSFULLY SNARED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15077716 ↗
• MalfunctionJan 14, 2021Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION A LESION LOCATED IN THE RIGHT POPLITEAL ARTERY THAT WAS MODERATELY TORTUOUS AND 100% OCCLUDED PRIOR TO THE INTERVENTION. A SUPERA STENT WAS IMPLANTED AT THE LESION. AFTER STENT IMPLANTATION, IT WAS NOTED THAT THE STENT WAS EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11172572 ↗
• MalfunctionOct 19, 2020Difficult to Remove; Material Separation; Activation Failure; Noise, Audible; Difficult to Remove; Material Separation; Activation Failure; Noise, Audible

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY AND THE STENT WAS DEPLOYED. THE STENT SEEMED TO DEPLOY WITHOUT ISSUE AND WAS THOUGHT TO BE FULLY DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED; HOWEVER, RESISTANCE WAS NOTED WHEN THE DELIVERY SYSTEM CAUGHT. THE DEVICE STOPPED MOVING, AND A POPPING NOISE WAS HEARD. ON ANGIOGRAPHY, IT WAS NOTED THAT THE NOSE CONE HAD DETACHED. THE NOSE CONE CAUGHT ON THE STENT. THE PHYSICIAN CONTINUED WITH REMOVAL OF THE STENT DELIVERY SYSTEM, AND IT WAS NOTED THAT THE STENT WAS BEING REMOVED WITH THE SHEATH. THE NOSE CONE REMAINED IN THE SHEATH AND WAS REMOVED WITH THE SHEATH AND STENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. A THIRD SUPERA WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10698099 ↗
• InjuryAug 31, 2020Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH NO TORTUOSITY OR CALCIFICATION BUT WITH 90% STENOSIS. THE VESSEL WAS 6 MM AND WAS PREPARED WITH LASER ATHERECTOMY AND A 6X100 MM BALLOON FOR 2 MINUTES. THE SHEATH WAS 6FR 90 CM. THE 6.0X100 MM SUPERA SELF EXPANDING STENT (SES) WAS DEPLOYED WITHOUT ISSUE. THERE WAS WAIST NOTED AT THE MID BODY OF THE STENT. REPORTEDLY, THE PHYSICIAN ROTATE THE SYSTEM LOCK AND THE DEPLOYMENT LOCK INTO THE LOCKED POSITION. THEN, THE TIP OF THE DELIVERY SYSTEM SEPARATED AND EMBOLIZED INTO THE PATIENT'S PERONEAL ARTERY WHERE IT REMAINS AS IT IS NOT ABLE TO BE RETRIEVED. NO RETRIEVAL ATTEMPT WAS MADE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OR REMOVAL. THE PATIENT DOES NOT HAVE LIMB THREATENING ISCHEMIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10473261 ↗
• MalfunctionNov 15, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL ARTERY. THE SUPERA SELF EXPANDING STENT (SES) WAS PARTIALLY DEPLOYED IN THE SHEATH AND WAS REMOVED IN THE SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. REPORTEDLY, ANOTHER SUPERA WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9331269 ↗
• MalfunctionNov 11, 2019Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUPERFICIAL FEMORAL (SFA) TO POPLITEAL ARTERY. A NON-ABBOTT ATHERECTOMY DEVICE WAS USED. THEN A 6MM NON-ABBOTT DRUG-ELUTING BALLOON WAS ADVANCED AND DISSECTED THE DISTAL SFA AND POPLITEAL. ABOUT SIX NON-ABBOTT STENTS WERE DEPLOYED AT THE LESION TO TREAT THE DISSECTION, BUT WERE UNSUCCESSFUL AS THE ARTERY REMAINED DISSECTED. THEN A NON-ABBOTT BALLOON WAS ADVANCED BUT FAILED TO CROSS. AN UNSPECIFIED ARMADA BALLOON WAS USED AND SUCCESSFULLY DILATED THE LESION. THE DISSECTION HAD RESOLVED. A 6.0X100 SUPERA SELF EXPANDING STENT WAS THEN ADVANCED TO THE LESION, WITH SOME RESISTANCE MET DUE TO THE ANATOMY, BUT REACHED THE DISSECTION. THE PHYSICIAN BELIEVED HE HAD DEPLOYED THE STENT WITHOUT ISSUE, BUT DID NOT REALIZE THAT HE DID NOT UNLOCK THE DEPLOYMENT LOCK FULLY TO THE MOST DISTAL POSITION ON THE HANDLE. THEN WHEN PULLING OUT THE DELIVERY SYSTEM THROUGH THE INTRODUCER SHEATH, IT WAS NOTED THAT THE STENT WAS ONLY PARTIALLY DEPLOYED AS THE ENTIRE STENT WAS PULLED BACK INTO THE SHEATH. RESISTANCE WAS MET WITH THE INTRODUCER SHEATH DURING REMOVAL. THE INTRODUCER SHEATH AND SUPERA DEVICE WERE REMOVED ALTOGETHER AS A SINGLE UNIT. ONCE OUT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306448 ↗
• InjuryNov 11, 2019Material Separation; Malposition of Device; Activation Failure; Material Separation; Malposition of Device; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATATION WITH AN UNSPECIFIED 6.0 MM BALLOON CATHETER WAS PERFORMED. THE SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITH NO DIFFICULTIES THROUGH A 6FR SHEATH. THE SESS BEGAN DEPLOYING PER THE INSTRUCTIONS FOR USE AT THE TARGET LESION; HOWEVER, DURING DEPLOYMENT THE STENT BECAME STUCK IN THE DISTAL END OF THE SHEATH AND WHEN THE STENT DELIVERY SYSTEM WAS WITHDRAWN, THE STENT BECAME STRETCHED AND THE NOSECONE SEPARATED. BUT BECAUSE THE VESSEL WAS PERFECTLY SIZED, THE STENT NORMALIZED AND JUMPED PROXIMALLY IN AN UNINTENDED SITE. THE NOSECONE REMAINED ON THE GUIDE WIRE. A SNARE DEVICE WAS USED TO HELP RETRIEVE THE NOSECONE SUCCESSFULLY. THE STENT REMAINS STABLE IN HEALTHY TISSUE. A NON-ABBOTT STENT WAS USED TO COVER THE LESION SUCCESSFULLY. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR DURING DEPLOYMENT OF THE DEVICE. THE PATIENT REMAINED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9305039 ↗
• MalfunctionMay 7, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN INCOMING INSPECTION AT THE DISTRIBUTION CENTER, A 6.0 X 100 MM SUPERA SELF -EXPANDING STENT SYSTEMS (SESS) WAS REJECTED FOR FOREIGN MATERIAL IN THE PACKAGING. THERE WAS NO REPORTED PROBLEM WITH THE STERILITY OF THE DEVICE. AS THE COSMETIC NON-CONFORMITY WAS NOTED AT THE DISTRIBUTION CENTER THERE WAS NO PATIENT INVOLVEMENT. THE SESS WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS ANALYSIS IDENTIFIED THAT THE FOREIGN MATERIAL IN THE PACKAGING WAS A MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 8587788 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO TREAT A SEVERELY CALCIFIED RIGHT POPLITEAL AND SUPERFICIAL FEMORAL ARTERY. A 6.0X100MM SUPERA STENT WAS IMPLANTED IN THE RIGHT PROXIMAL POPLITEAL, AND A 6.5X150MM SUPERA STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), OVERLAPPING THE 6.0X100MM SUPERA STENT. THERE WERE NO REPORTED ISSUES DURING THE PROCEDURE. THE PATIENT WAS COMPLIANT WITH PLAVIX AND ASPIRIN MEDICATIONS FOLLOWING THE PROCEDURE; HOWEVER, THE DOSAGE IS UNKNOWN. ON (B)(6) 2019, THE PATIENT PRESENTED WITH LEG CLAUDICATION AND A SEVERELY CALCIFIED RIGHT POPLITEAL AND SFA. ANGIOGRAPHY DISCOVERED RESTENOSIS IN THE PREVIOUSLY IMPLANTED SUPERA STENTS AND THROMBUS DISTAL TO THE STENTS THAT SHUT DOWN BOTH STENT SEGMENTS AND RESULTED IN NO FLOW. A NON-ABBOTT STENT WAS DEPLOYED AND SUFFICIENTLY RESTORED THE BLOOD FLOW. THERE WAS NO ADVERSE PATIENT SEQUELA, AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Stenosis; Thrombosis

  MAUDE report 8376030 ↗
• InjuryDec 4, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED COMMON FEMORAL ARTERY. AFTER DEPLOYMENT OF A 6.0X100 MM SUPERA STENT AND DURING REMOVAL OF THE STENT DELIVERY SYSTEM, THE NOSE CONE DETACHED WITHIN THE PATIENT. IT WAS DECIDED TO USE A BUDDY-WIRE TECHNIQUE FOR RETRIEVAL OF THE SEPARATED SEGMENT. AN UNSPECIFIED ARMADA BALLOON WAS INFLATED DISTAL TO THE SEPARATED NOSE CONE SEGMENT AND DRAGGED THE BALLOON BACK WHICH BROUGHT BACK THE NOSE CONE INTO THE 6FR SHEATH AND REMOVED COMPLETELY FROM THE ANATOMY. THE PATIENT WAS FINE. IT WAS SUSPECTED THAT THE SUPERA DEVICE WAS NOT PROPERLY LOCKED BEFORE REMOVAL CAUSING THE NOSE CONE DETACHMENT, HOWEVER THIS COULD NOT BE CONFIRMED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8129337 ↗
• MalfunctionFeb 28, 2018Positioning Failure; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POPLITEAL ARTERY. THE ARTERY WAS 6.0 IN DIAMETER. PRE-DILATATION WAS PERFORMED WITH A 5.0 BALLOON CATHETER. THE 6.0X100MM SUPERA STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WITHOUT ISSUE AND AFTER UNLOCKING THE FINAL LOCK THE STENT WAS BELIEVED TO BE DEPLOYED; HOWEVER, AFTER REMOVAL OF THE DELIVERY CATHETER FROM THE ANATOMY THE STENT IMPLANT WAS OBSERVED TO BE STILL ATTACHED TO THE DELIVERY CATHETER. RETRACTION WAS PERFORMED WHILE USING INTRAVASCULAR ULTRASOUND (IVUS). A NEW 6 X 120 MM SUPERA STENT DELIVERY SYSTEM WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304526 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2017 WAS PERFORMED TO TREAT LESIONS LOCATED IN THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES. THERE WAS MILD TORTUOSITY AND MILD CALCIFICATION PRESENT PRIOR TO STENTING. TWO SUPERA STENTS (6.0 X 80 MM AND 6.0 X 100 MM) STENTS WERE DEPLOYED FOR TREATMENT OF THE LESIONS. ON (B)(6) 2018, THE PATIENT BEGAN EXPERIENCING PAIN AT REST AND CLAUDICATION AND IT WAS CONFIRMED THAT BOTH SUPERA STENTS HAD OCCLUDED. THE PATIENT IS BEING REEVALUATED AT THIS TIME; HOWEVER, NO TREATMENT HAS BEEN PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Pain

  MAUDE report 7184631 ↗
• InjuryNov 14, 2017Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD CALCIFICATION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0 X 100 MM SUPERA PERIPHERAL STENT SYSTEM WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION, AND THE STENT WAS DEPLOYED SUCCESSFULLY. HOWEVER, DURING WITHDRAWAL OF THE SUPERA, THE DEVICE BECAME STUCK ON THE GUIDE WIRE. THE HANDLE HAD TO BE DISMANTLED IN ORDER TO BE ABLE TO PULL THE DEVICE OUT FROM THE PATIENT ANATOMY. THE PATIENT OUTCOME WAS SATISFACTORY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7031582 ↗
• InjuryAug 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 THREE SUPERA STENTS WERE DEPLOYED IN THE SUPERFICIAL FEMORAL ARTERY. DUE TO RESTENOSIS OBSERVED IN THE PREVIOUSLY TREATED AREA, THE PATIENT UNDERWENT REVASCULARIZATION ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 5914939 ↗