SUPERA S-55-150-120-P6 (UDI 08975370026337)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08975370026337), received between Sep 21, 2016 and May 9, 2019 — classified as 12 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2019Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PREPARATION OF THE SUPERA SELF EXPANDING STENT SYSTEM (SESS), THE NOSE CONE WAS INADVERTENTLY RIPPED OFF THE DEVICE AS IT WAS THOUGHT TO BE A STYLET. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW, SAME SIZE SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8597211 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017,A SUPERA STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL ARTERY (SFA) THAT WAS 100% STENOSED. ON (B)(6) 2017, A SUPERA STENT WAS IMPLANTED IN THE LEFT SUPERFICIAL ARTERY THAT WAS 95% STENOSED. ON (B)(6) 2017, THE PATIENT REPORTED HAVING SEVERE PAIN IN THE LEFT LEG WHICH MADE IT VERY DIFFICULT TO WALK. ON (B)(6) 2017, AN ADDITIONAL SUPERA STENT AND A NON-ABBOTT STENT WERE IMPLANTED IN THE LEFT SFA ARTERY AS IT WAS NOTED THROUGH ANGIOGRAPHY THAT THE PREVIOUSLY IMPLANTED SUPERA STENT HAD BECOME RESTENOSED. AFTER THE PROCEDURE, THE PHYSICIAN PRESCRIBED THE PATIENT WITH MEDICATION, WHICH THE PATIENT CONTINUES TO TAKE PRESENTLY. INITIALLY, LEFT LEG PAIN WAS ELIMINATED AFTER THE PROCEDURE ON (B)(6) 2017. MINOR PAIN EMERGED AGAIN IN THE LEFT CALF IN (B)(6) 2018. DURING AN ARTERIAL ULTRASOUND ON (B)(6) 2018, THE PHYSICIAN CONFIRMED THAT THE PULSE IN THE LEFT ANKLE HAD WEAKENED. PHYSICIAN DOES NOT BELIEVE AN ADDITIONAL INTERVENTION ON THE LEFT LEG IS NECESSARY. IN (B)(6) 2018, THE PATIENT REPORTED HAVING VERY SEVERE PAIN IN HER RIGHT CALF AND DIFFICULTY WALKING. THEN ON (B)(6) 2018, AN ARTERIAL ULTRASOUND WAS PERFORMED ON THE RIGHT LEG BECAUSE OF INCREASED PA

  Patient problems: Diminished Pulse Pressure; Pain; Stenosis

  MAUDE report 7504871 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017,A SUPERA STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL ARTERY (SFA) THAT WAS 100% STENOSED. ON (B)(6) 2017, A SUPERA STENT WAS IMPLANTED IN THE LEFT SUPERFICIAL ARTERY THAT WAS 95% STENOSED. ON (B)(6) 2017, THE PATIENT REPORTED HAVING SEVERE PAIN IN THE LEFT LEG WHICH MADE IT VERY DIFFICULT TO WALK. ON (B)(6) 2017, AN ADDITIONAL SUPERA STENT AND A NON-ABBOTT STENT WERE IMPLANTED IN THE LEFT SFA ARTERY AS IT WAS NOTED THROUGH ANGIOGRAPHY THAT THE PREVIOUSLY IMPLANTED SUPERA STENT HAD BECOME RESTENOSED. AFTER THE PROCEDURE, THE PHYSICIAN PRESCRIBED THE PATIENT WITH MEDICATION, WHICH THE PATIENT CONTINUES TO TAKE PRESENTLY. INITIALLY, LEFT LEG PAIN WAS ELIMINATED AFTER THE PROCEDURE ON (B)(6) 2017. MINOR PAIN EMERGED AGAIN IN THE LEFT CALF IN (B)(6) 2018. DURING AN ARTERIAL ULTRASOUND ON (B)(6) 2018, THE PHYSICIAN CONFIRMED THAT THE PULSE IN THE LEFT ANKLE HAD WEAKENED. PHYSICIAN DOES NOT BELIEVE AN ADDITIONAL INTERVENTION ON THE LEFT LEG IS NECESSARY. IN (B)(6) 2018, THE PATIENT REPORTED HAVING VERY SEVERE PAIN IN HER RIGHT CALF AND DIFFICULTY WALKING. THEN ON (B)(6) 2018, AN ARTERIAL ULTRASOUND WAS PERFORMED ON THE RIGHT LEG BECAUSE OF INCREASED PA

  Patient problems: Diminished Pulse Pressure; Pain; Stenosis

  MAUDE report 7504845 ↗
• MalfunctionApr 2, 2018Detachment Of Device Component

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE SUPERA TIP (NOSE CONE) WAS INADVERTENTLY PULLED OFF. THERE WAS NO OTHER DEVICE ISSUE NOTED. THERE WAS NO PATIENT INVOLVEMENT AND THE DEVICE WAS NOT USED IN A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7390789 ↗
• InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 5 X 150MM SUPERA STENT WAS IMPLANTED ON (B)(6) 2017 ON THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY THAT WAS MODERATELY CALCIFIED. PATIENT EXPERIENCED CLAUDICATION ON THE RIGHT LOWER EXTREMITY. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2018, AND AN ANGIOGRAM WAS PERFORMED WHICH REVEALED RESTENOSIS. REVASCULARIZATION WAS PERFORMED DUE TO ISCHEMIA. A NON-ABBOTT ATHERECTOMY DEVICE SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; Claudication; Ischemia

  MAUDE report 7344976 ↗
• MalfunctionMar 9, 2018Positioning Failure; Difficult To Position

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER ADVANCEMENT OF THE SUPERA STENT DELIVERY SYSTEM TO THE LESION THERE WAS DIFFICULTY VISUALIZING THE STENT WHICH RESULTED IN DEPLOYMENT OF THE STENT PARTIALLY IN THE LESION AND PARTIALLY IN THE SHEATH. THE DELIVERY SYSTEM WITH THE STENT PARTIALLY INSIDE THE SHEATH WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. AS VESSEL ACCESS WAS LOST THE PROCEDURE ENDED. 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 7329232 ↗
• MalfunctionJan 18, 2018Detachment Of Device Component

  IT WAS REPORTED THAT WHEN THE SUPERA PACKAGE WAS OPENED AND THE DEVICE WAS REMOVED IT WAS NOTED THAT NOSECONE WAS SEPARATED. THERE WAS NO ISSUE DURING UNPACKING OR REMOVAL OF THE DEVICE FROM THE PACKAGE. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7204207 ↗
• InjuryDec 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT THROMBOSIS WAS OBSERVED VIA ANGIOGRAPHY IN THE SUPERA STENTS THAT WERE DEPLOYED ON (B)(6) 2016. THE STENTS WERE LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND THE POPLITEAL. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT ISSUE. THERE WAS NO RECORD OF EXISTING THROMBOSIS IN THE PATIENT PRIOR TO STENTING. THE PATIENT WAS EXPERIENCING PAIN AT REST WHICH LED TO THE ANGIOGRAPHY WHICH TOOK PLACE ON (B)(6) 2016 REVEALING IN-STENT THROMBOSIS. THROMBOLYSIS WAS PERFORMED AND ON THE FOLLOWING DAY A NON-ABBOTT STENT WAS PLACED. THE PATIENT RETURNED AGAIN APPROXIMATELY 1 MONTH LATER WITH REPEAT IN-STENT THROMBOSIS FOR WHICH THE PATIENT WAS SENT FOR SURGERY FOR AN ABOVE THE KNEE AMPUTATION. IT WAS CONFIRMED THAT THE PATIENT HAD NOT BEEN COMPLIANT WITH HIS POST-PROCEDURAL MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Thrombosis

  MAUDE report 7139876 ↗
• InjuryDec 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT THROMBOSIS WAS OBSERVED VIA ANGIOGRAPHY IN THE SUPERA STENTS THAT WERE DEPLOYED ON (B)(6) 2016. THE STENTS WERE LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND THE POPLITEAL. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT ISSUE. THERE WAS NO RECORD OF EXISTING THROMBOSIS IN THE PATIENT PRIOR TO STENTING. THE PATIENT WAS EXPERIENCING PAIN AT REST WHICH LED TO THE ANGIOGRAPHY WHICH TOOK PLACE ON (B)(6) 2016 REVEALING IN-STENT THROMBOSIS. THROMBOLYSIS WAS PERFORMED AND ON THE FOLLOWING DAY A NON-ABBOTT STENT WAS PLACED. THE PATIENT RETURNED AGAIN APPROXIMATELY 1 MONTH LATER WITH REPEAT IN-STENT THROMBOSIS FOR WHICH THE PATIENT WAS SENT FOR SURGERY FOR AN ABOVE THE KNEE AMPUTATION. IT WAS CONFIRMED THAT THE PATIENT HAD NOT BEEN COMPLIANT WITH HIS POST-PROCEDURAL MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Thrombosis

  MAUDE report 7139842 ↗
• InjurySep 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A SUPERA 5.5 X 150 SELF-EXPANDING STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2017, THE PATIENT WAS RE-VASCULARIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6843464 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SUPERA 5.5 X 150 6F SELF-EXPANDING STENT WAS IMPLANTED ON (B)(6) 2016. THE PATIENT WAS RE-VASCULARIZED ON (B)(6) 2017. DUPLEX FOLLOW-UP WAS SCHEDULED FOR (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6830826 ↗
• MalfunctionAug 1, 2017Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, LONG TOTALLY OCCLUDED, LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AFTER LESION PREDILATATION WITH A 6 X 150 MM ARMADA 18 BALLOON CATHETER, THE SUPERA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. THE STENT WAS PARTIALLY DEPLOYED WHEN RESISTANCE WAS MET IN THE CATHETER AND THE THUMBSLIDE. THE THUMBSLIDE WAS PULLED BACK/LOCKED AND THE PARTIALLY DEPLOYED STENT/SDS WAS REMOVED OVER THE GUIDE WIRE FROM THE ANATOMY WITHOUT REPORTED ISSUE. A DIFFERENT SUPERA STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6759088 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, 2 SUPERA STENTS WERE SUCCESSFULLY IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED DUE TO CLAUDICATION. A DRUG COATED BALLOON CATHETER WAS USED AS TREATMENT WITH A GOOD OUTCOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Stenosis

  MAUDE report 6645793 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, 2 SUPERA STENTS WERE SUCCESSFULLY IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED DUE TO CLAUDICATION. A DRUG COATED BALLOON CATHETER WAS USED AS TREATMENT WITH A GOOD OUTCOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Stenosis

  MAUDE report 6645788 ↗
• MalfunctionApr 10, 2017Positioning Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. A 5.5X150MM SUPERA PERIPHERAL STENT SYSTEM WAS ADVANCED TO THE LESION AND THOUGHT TO HAVE BEEN DEPLOYED; HOWEVER, WHEN THE DEVICE WAS REMOVED THE STENT WAS STILL ON THE DEVICE. IT WAS NOTED THAT THE PHYSICIAN DID NOT UNLOCK THE DEVICE WHEN DEPLOYING IT. ADDITIONALLY, RESISTANCE WAS FELT WHEN REMOVING THE DEVICE AND THE STENT STRETCHED GREATER THAN 10%. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6477478 ↗
• InjuryFeb 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, TWO SUPERA STENTS WERE IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). SEVERAL WEEKS LATER, THE PATIENT HAD LEG PAIN AT REST. CT SCAN OF THE PATIENT FOUND RESTENOSIS IN THE 5.5 DIAMETER SUPERA STENT. THE 6.0 DIAMETER SUPERA STENT WAS FULLY PATENT. THE PATIENT WILL BE SCHEDULED FOR A FEMORAL-POPLITEAL BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Stenosis

  MAUDE report 6347885 ↗
• InjuryNov 17, 2016Material Deformation

  IT WAS REPORTED THAT THE 5.5X150 SUPERA STENT HAD BECOME TWISTED, TELESCOPED FROM MOVEMENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WHEN THE PATIENT WAS WALKING AND THE PATIENT HAD LEG PAIN. THE 7.0 X 29 OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS INSERTED TO HELP STRAIGHTEN OUT THE VESSEL TO ALLOW ANOTHER SUPERA TO BE DEPLOYED IN THE SFA, BUT THE SDS INTERACTED WITH THE OCCLUDED SUPERA STENT. THE SDS WAS REMOVED AND THE SUPERA WAS BALLOON DILATED. THE OMNILINK SDS WAS RE-INSERTED, BUT THE OMNILINK STENT DISLODGED FROM THE SDS BALLOON. THE SDS WAS USED TO PUSH THE DISLODGED STENT AS FAR DOWN AS THEY COULD GET IT AND THE OMNILINK STENT WAS DEPLOYED WITH A 4.0X100 NON-ABBOTT BALLOON. THE OMNILINK SDS WAS RE-INSERTED AND INFLATED FOR POST DILATATION. ANOTHER SUPERA WAS IMPLANTED, AS PLANNED, TO TREAT THE OCCLUDED 5.5X150 SUPERA. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion; Pain

  MAUDE report 6111336 ↗
• MalfunctionOct 19, 2016Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS A MILDLY CALCIFIED, RESTENOSED MID SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED WITH A 5.5 X 100 MM ARMADA BALLOON CATHETER FOR 2 INFLATIONS FOR 2 MINUTES TO PRE-DILATED 150 MM OF THE LESION. A 5.5 X 150 MM SUPERA STENT WAS SUCCESSFULLY DEPLOYED. IT WAS CONFIRMED THAT THE STENT WAS COMPLETELY DEPLOYED AND AWAY FROM THE SHEATH. THE THUMBSLIDE WAS LOCKED AND THE DEVICE WAS REMOVED WITHOUT RESISTANCE. ANGIOGRAPHY CONFIRMED THE STENT WAS FULLY APPOSED TO THE VESSEL WALL. WHEN ATTEMPTING TO POST-DILATE, IT WAS NOTED THAT THE STENT HAD ELONGATED FROM 150 TO 250 MM. POST-DILATATION WAS PERFORMED WITH THE SAME 5.5 X 100 MM ARMADA THAT WAS USED FOR PRE-DILATATION TO COMPLETE THE PROCEDURE. THE PATIENT IS DOING FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6041692 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE WAS ON (B)(6) 2016 WHERE A 5.5 X 150 MM SUPERA STENT WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2016 THE PATIENT RETURNED WITH A TOTAL OCCLUSION. THE RESTENOSIS WAS TREATED WITH PLACEMENT OF ANOTHER STENT AND THE RESIDUAL STENOSIS WAS LESS THAN 10%. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 5998054 ↗
• MalfunctionSep 21, 2016Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT, WITH AN UNSPECIFIED 0.014 IN GUIDE WIRE ADVANCED TO THE HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY, AN ATTEMPT WAS MADE TO ADVANCE A 5.5X150 6FR 120CM SUPERA PERIPHERAL STENT SYSTEM ONTO THE GUIDE WIRE, HOWEVER, THE SUPERA WAS ONLY ABLE TO BE ADVANCED APPROXIMATELY 1 INCH ONTO THE GUIDE WIRE BEFORE BECOMING STUCK (UNABLE TO ADVANCE OR RETRACT). AS THE SUPERA HAD NOT YET ENTERED PATIENT ANATOMY, FORCE WAS APPLIED TO RETRACT THE STUCK SUPERA FROM THE GUIDE WIRE. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER SAME SIZE SUPERA ONTO THE SAME GUIDE WIRE, BUT THIS SUPERA WAS ALSO ONLY ABLE TO BE ADVANCED APPROXIMATELY 1 INCH ONTO THE GUIDE WIRE BEFORE BECOMING STUCK (UNABLE TO ADVANCE OR RETRACT). FORCE WAS APPLIED TO RETRACT THE STUCK SUPERA FROM THE GUIDE WIRE. ANOTHER (3RD) SAME SIZE SUPERA WAS ABLE TO BE ADVANCED OVER THE SAME GUIDE WIRE WITHOUT ISSUE AND WAS SUCCESSFULLY DEPLOYED, COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5967881 ↗
• MalfunctionSep 21, 2016Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT, WITH AN UNSPECIFIED 0.014 IN GUIDE WIRE ADVANCED TO THE HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY, AN ATTEMPT WAS MADE TO ADVANCE A 5.5X150 6FR 120CM SUPERA PERIPHERAL STENT SYSTEM ONTO THE GUIDE WIRE, HOWEVER, THE SUPERA WAS ONLY ABLE TO BE ADVANCED APPROXIMATELY 1 INCH ONTO THE GUIDE WIRE BEFORE BECOMING STUCK (UNABLE TO ADVANCE OR RETRACT). AS THE SUPERA HAD NOT YET ENTERED PATIENT ANATOMY, FORCE WAS APPLIED TO RETRACT THE STUCK SUPERA FROM THE GUIDE WIRE. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER SAME SIZE SUPERA ONTO THE SAME GUIDE WIRE, BUT THIS SUPERA WAS ALSO ONLY ABLE TO BE ADVANCED APPROXIMATELY 1 INCH ONTO THE GUIDE WIRE BEFORE BECOMING STUCK (UNABLE TO ADVANCE OR RETRACT). FORCE WAS APPLIED TO RETRACT THE STUCK SUPERA FROM THE GUIDE WIRE. ANOTHER (3RD) SAME SIZE SUPERA WAS ABLE TO BE ADVANCED OVER THE SAME GUIDE WIRE WITHOUT ISSUE AND WAS SUCCESSFULLY DEPLOYED, COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5967865 ↗