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

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08717648211836), received between Sep 7, 2016 and May 28, 2026 — classified as 20 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (17 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT COMMON ILIAC ARTERY LESION WITH 70% STENOSIS. A 6X150 MM SUPERA SELF-EXPANDING STENT (SES) WAS IMPLANTED WITHOUT ISSUE IN THE DISTAL LESION. A 6X120 MM SUPERA SES WAS ALSO ADVANCED TO THE TARGET LESION; HOWEVER, DURING DEPLOYMENT, THE TIP GOT CAUGHT AT THE JUNCTION OF THE TWO SUPERA STENTS, CAUSING THE TIP TO SEPARATE WITHIN THE VESSEL. AFTER DETECTING THE TIP SEPARATION, THE DELIVERY SYSTEM WAS WITHDRAWN PRIOR TO STENT DEPLOYMENT, CAUSING STRETCHING AND MALFORMATION OF THE STENT. SURGERY WAS PERFORMED TO RETRIEVE THE SEPARATED TIP AND EXPLANT BOTH STENTS. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318977 ↗
• InjuryMay 19, 2026Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PRE-EXISTING DISSECTION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE 6 X 120 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DURING DEPLOYMENT THE STENT ELONGATED INTO THE SHEATH AND RELEASE OF THE STENT WAS UNABLE TO BE ACTIVATED. THE NOSE CONE SEPARATED. THE SHEATH AND A NON-ABBOTT IMPLANT WERE REMOVED AND A SNARE WAS USED TO RETRIEVE THE NOSE CONE. THE CASE WAS DELAYED IN ORDER TO RETRIEVE THE NOSE CONE. NON-ABBOTT STENTS WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222350 ↗
• MalfunctionMay 11, 2026Material Separation; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X120MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT IT WAS NOTED THE TIP OF THE SES CAUGHT ON THE STENT AND DETACHED; THEREFORE THE PHYSICIAN PULLED OUT THE SES, STENT, AND THE DETACHED TIP. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SUPERA'S AND AN ABSOLUTE PRO. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137730 ↗
• MalfunctionApr 2, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT WHEN UNBOXING THE 6.0X120MM SUPERA SELF EXPANDING STENT SYSTEM, THE STERILE PACKAGING INSIDE THE CHIPBOARD BOX WAS ALREADY OPENED. 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 24766438 ↗
• InjuryJul 24, 2025Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X120MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT, THE STENT DID NOT FULLY DETACH AT FIRST. THE STENT WAS ABLE TO BE FULLY DEPLOYED HOWEVER THE TIP OF THE SES SEPARATED. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED TIP WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591928 ↗
• InjuryJun 18, 2025Material Separation; Migration; Material Separation; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 70% STENOSED LESION IN THE POPLITEAL ARTERY. THE VESSEL WAS PREDILATED USING A 4X150MM AND 6X200MM NON-ABBOTT BALLOON, WITH NO ATHERECTOMY NOTED. FOLLOWING THIS A 6.0X120MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS ADVANCED THROUGH A 6FR 45CM SHEATH AND OVER A 018 COMMAND GUIDEWIRE (GW) TO THE LESION AND DEPLOYED AT THE THE TARGET LESION. IT WAS NOTED THAT THE STENT WAS FULLY DEPLOYED WITH THE THUMB SLIDE ADVANCED TO THE DISTAL PORTION OF THE HANDLE WITH THE DISTAL END OF THE SHEATH BEING LOCATED AT A SUBSTANTIAL DISTANCE AWAY WITH PROXIMAL ENDED OF THE STENT IN THE POPLITEAL AND THE DISTAL END OF THE SHEATH IN THE COMMON FEMORAL ARTERY. HOWEVER FOLLOWING WITHDRAWAL UNDER FLUOROSCOPY WITH THE HANDLE IN THE LOCKED POSITION, IT WAS NOTED THAT THE STENT MIGRATED TO THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS LOCATED WITHIN A STENT THAT WAS PREVIOUSLY IMPLANTED DURING THE PROCEDURE. IN ADDITIONAL THE CONE TIP OF THE DELIVERY CATHETER WAS NOTED TO BE SEPARATED AND FLOATING IN THE SFA. THEREFORE AN ADDITIONAL STENT WAS ADVANCE TO EMBED THE FLOATING TIP TO THE VESSEL WALL IN THE POPLITEAL AND ADDITIONAL BALLOON CATHETER W

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22288168 ↗
• MalfunctionMar 17, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND 90% STENOSIS. THE VESSEL DIAMETER IS 6 MM AND THE VESSEL WAS PREPARED WITH A 7 MM BALLOON AT 18 ATMOSPHERES FOR 30 SECONDS. DURING DEPLOYMENT OF THE 6X120 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), THE RATCHET FAILED TO ENGAGE AND THE STENT PARTIALLY DEPLOYED. ATTEMPTS WERE MADE TO ADJUST THE DEVICE BUT ULTIMATELY THE DELIVERY SYSTEM AND THE STENT WERE RETRACTED INTO THE GUIDING CATHETER AND REMOVED. ANOTHER SAME SIZE SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21624372 ↗
• MalfunctionFeb 5, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT SUPERIOR FEMORAL ARTERY THAT IS 90% STENOSED. THE VESSEL WAS PREPARED WITH A 6X40MM UNSPECIFIED DEVICE. THE 6.0X120MM SUPERA SELF-EXPANDING STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE RESISTANCE WAS FELT WHEN MOVING THE THUMBSILDE AND THE STENT WOULD NOT DEPLOY. THE SUPERA WAS REMOVED UNDER FLUOROSCOPY AND A NEW SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION REPORTED THAT THE SUPERA SELF-EXPANDING STENT PARTIALLY DEPLOYED PROTRUDING FROM THE STENT SHEATH FOR A LENGTH OF 3MM (MILLIMETERS). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317529 ↗
• MalfunctionSep 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0X120MM SUPERA SELF EXPANDING STENT SYSTEM (SES), THE NOSE CONE WAS NOTED TO BE SEPARATED FROM THE DEVICE. 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 20281151 ↗
• InjurySep 12, 2024Difficult to Remove; Stretched; Activation Failure; Difficult to Remove; Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). REPORTEDLY A 6.0X120MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE TARGET LESION; HOWEVER DURING DEPLOYMENT ELONGATION OF THE STENT OCCURRED AND PROXIMAL END OF THE STENT WAS DEPLOYED INSIDE THE DELIVERY SHEATH. THE SES COULD NOT BE REMOVED, SO THE PHYSICIAN PERFORMED A CUT DOWN AND REMOVED THE STENT. A NON-ABBOTT STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199061 ↗
• InjuryJul 11, 2024Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Difficult to Advance; Migration; Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Difficult to Advance; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION IN THE HEAVILY CALCIFIED, MILD TORTUOSITY AND SEVERELY STENOSED RIGHT SUPERFICIAL FEMORAL ARTERY. USING A RETROGRADE APPROACH, ACCESS WAS OBTAIN IN THE LEFT FEMORAL, AND PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED 6MM BALLOON. THE 6.0 X 120 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED OVER AN UNSPECIFIED 0.014 GUIDE WIRE. RESISTANCE WAS NOTED DURING ADVANCEMENT DUE TO THE PATIENT ANATOMY. THE STENT WAS DEPLOYED AT THE TARGET LESION YET ELONGATED, AND MIGRATED TO THE COMMON FEMORAL ARTERY WHERE A CALCIUM ROCK WAS PRESENT. IN AN ATTEMPT TO AVOID THE CALCIUM ROCK, THE STENT WAS ATTEMPTED TO BE RETRACTED BACK ONTO THE DELIVERY SYSTEM, YET RESISTANCE WAS NOTED DUE TO THE HEAVY CALCIFICATION. THE STENT FURTHER MIGRATED TO THE CALCIUM ROCK CAUSING THE STENT TO FURTHER ELONGATE THROUGH A BIFURCATION AT THE ILIAC WHERE A PRIOR STENT WAS IMPLANTED AND ENDED IN THE PROXIMAL ILIAC ARTERY. IN ADDITION, THE NOSE CONE OF THE SUPERA SESS SEPARATED IN THE ILIAC ARTERY AND WAS RETRIEVED USING A SNARE. THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL CARE FACILITY FOR VASCULAR ENDARTERECTOMY AND STENT REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19723909 ↗
• InjuryMay 16, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X120MM SUPERA STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER, DURING THE REMOVAL OF THE DELIVERY SYSTEM SOME RESISTANCE WAS FELT WITH THE DEVICE ITSELF AND THE NOSE CONE SEPARATED. THE NOSE CONE WAS RETRIEVED VIA SNARE AND INTRAVASCULAR ULTRASOUND CONFIRMED THERE WAS NO ISSUE WITH THE DEPLOYED STENT. HOWEVER, IT WAS NOTED THAT DURING REMOVAL OF THE DELIVERY SYSTEM, THE SYSTEM LOCK AND DEPLOYMENT LOCK WERE NOT LOCKED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333717 ↗
• MalfunctionApr 4, 2023Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT SUPERIOR FEMORAL ARTERY. THE LESION WAS PREPARED WITH A NON-ABBOTT BALLOON 7.0X60MM AT 20 ATMOSPHERES FOR ONE INFLATION. DURING DEPLOYMENT OF THE 6.0X120MM SUPERA STENT STRONG RESISTANCE WAS NOTED WITH THE THUMBSILDE AND THE DEVICE PARTIALLY DEPLOYED. THE PARTIALLY DEPLOYED SUPERA WAS REMOVED FROM THE ANATOMY UNDER FLUOROSCOPY. A 6.5X60MM SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675167 ↗
• MalfunctionAug 16, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A SUPERA STENT WAS SUCCESSFULLY DEPLOYED, HOWEVER, WHEN PERFORMING A WIRE EXCHANGE WITH A COMMAND 18 GUIDEWIRE, WIRE ACCESS WAS LOST DUE TO RESISTANCE WITH THE GUIDEWIRE AND SUPERA DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED AND THE VESSEL RE-WIRED, WITHOUT FURTHER ISSUE OR INTERVENTION. THE STENT WAS WELL PLACED AND THE LESION WELL TREATED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A COMMAND 014 WIRE WAS SUCCESSFULLY USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237949 ↗
• MalfunctionAug 13, 2022Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 100% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA). A 5.5X150 MM SUPERA STENT WAS IMPLANTED IN THE RIGHT SFA WITHOUT REPORTED ISSUES. THE 6.0X120 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS INTENDED TO BE PLACED PROXIMALLY, HOWEVER, THE DELIVERY SYSTEM BECAME TRAPPED WITH THE GUIDE WIRE BEFORE THE SHEATH WAS INTRODUCED AND THE TIP SEPARATED OUTSIDE THE ANATOMY. THE SUPERA SESS WAS REMOVED FROM THE GUIDE WIRE WITH RESISTANCE NOTED AND A 6.0X80 MM SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222647 ↗
• MalfunctionMay 31, 2022Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT SUPERIOR FEMORAL ARTERY. USING A CROSS OVER APPROACH FROM THE COMMON FEMORAL ARTERY PRE-DILATATION WAS PERFORMED THREE TIMES AT 18 ATMOSPHERES WITH AN UNSPECIFIED DEVICE. A 6.0X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, IT WAS ONLY PARTIALLY DEPLOYED. IT WAS NOTED DURING ADVANCEMENT RESISTANCE WAS MET WITH A NON-ABBOTT GUIDE CATHETER. THE SUPERA WAS REMOVED UNDER FLUOROSCOPY AND A NEW 6.0X80MM SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14551553 ↗
• MalfunctionApr 26, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. AFTER VESSEL ACCESS, THE LESION WAS PRE-TREATED WITH BALLOON ANGIOPLASTY. THE 6.0X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYMENT INITIATED; HOWEVER, THE STENT ONLY PARTIALLY DEPLOYED. THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE WAS ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE. THE SESS, INCLUDING THE PARTIALLY DEPLOYED STENT, WAS REMOVED UNDER FLUOROSCOPY WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SUPERA STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214278 ↗
• MalfunctionFeb 9, 2022Difficult or Delayed Activation; Defective Device; Difficult or Delayed Activation; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, CONCENTRIC STENOSIS IN A HEAVILY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA) USING A CROSS-OVER APPROACH. THE VESSEL DIAMETER WAS 6 MM AND PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT DEVICE AT A PRESSURE OF 20 ATMOSPHERES (ATMS) FOR 60 SECONDS. ATHERECTOMY WAS NOT USED. THE 6.0X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO DEPLOY BUT THE STENT ONLY PARTIALLY RELEASED. THE SYSTEM WAS PULLED UNDER FLUOROSCOPY FOR TROUBLESHOOTING AND THE STENT WAS ABLE TO BE RELEASED GRADUALLY RESPONDING WITH THE THUMB SLIDE BUT TOOK MORE TIME THAN USUAL, HOWEVER, THERE WAS NO PROBLEM IN THE DEPLOYMENT MECHANISM. IT WAS ALSO NOTED THAT THE DEPLOYED STENT WAS 2 CM SHORTER THAN INTENDED BUT FULLY COVERED THE LESION. THERE WERE NO CONCERNS WITH THE LOCATION OR CONDITION OF THE DEPLOYED STENT AS IT FULLY COVERED THE LESION AND DID NOT MOVE FROM THE DEPLOYED LOCATION AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498451 ↗
• InjuryDec 1, 2021Material Separation; Improper or Incorrect Procedure or Method; Activation Failure; Material Separation; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS PREDILATED WITH 5.0X80MM AND 5X150MM NON-ABBOTT BALLOONS. THE 3.0X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED; HOWEVER, DURING REMOVAL UNDER FLUOROSCOPY THE NOSE CONE SEPARATED INSIDE THE SHEATH AND THE STENT WAS PULLED BACK WITH THE SESS. THE PATIENT BECAME HYPOTENSIVE AND A FEMOSTOP WAS USED TO APPLY PRESSURE TO THE ACCESS SITE AS DURING REMOVAL OF THE SUPERA IT CREATED A LAGER HOLE. IT WAS NOTED THE THUMBSLIDE WAS NOT SLID ALL THE WAY BACK. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Tissue Injury

  MAUDE report 12910904 ↗
• InjuryJun 21, 2021Entrapment of Device; Material Separation; Migration; Entrapment of Device; Material Separation; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS PERIPHERAL INTERVENTION WAS PERFORMED ON THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) LESION. A SHOCKWAVE (6.060MM) AND REGULAR 4.0X40MM BALLOON CATHETER UP TO 12 ATMOSPHERES PREPPED THE VESSEL. A SUPERA STENT DELIVERY SYSTEM ADVANCED TO THE TREATMENT SITE WITHOUT ISSUE. AT THE END OF STENT DEPLOYMENT, WHICH HAD BEEN SUCCESSFUL, WITHOUT ISSUES, IT WAS OBSERVED THAT THE TIP (NOSE CONE) WAS STUCK ON THE DEPLOYED STENTS STRUT. THE FULLY DEPLOYED STENT WAS DEPLOYED AT THE INTENDED LOCATION, HOWEVER, DUE TO THE TIP BEING CAUGHT ON THE STENT STRUT, AND DURING DELIVERY SYSTEM REMOVAL ATTEMPT, THE STENT HAD THEN MOVED TO AN UNINTENDED, NON-TARGET LOCATION. THE TIP HAD SUBSEQUENTLY SEPARATED FROM THE DELIVERY CATHETER. ALL WAS LEFT IN PLACE AND THE PATIENT WAS TAKEN FOR SURGERY. THE SEPARATED TIP AND STENT WERE REMOVED DURING SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033240 ↗
• InjuryFeb 26, 2021Material Separation; Stretched; Activation Failure; Material Separation; Stretched; Activation Failure

  IT WAS REPORTED THAT ON (B)(6) 2021 A SUPERA STENT WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2021, THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT POPLITEAL ARTERY. THE VESSEL DIAMETER WAS 6MM. A 6MM ANGIOPLASTY BALLOON WAS USED TO PREP THE VESSEL. THE 6.0X120MMX120CM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) (LOT# 9061961) WAS ADVANCED TO THE TARGET LESION AND DEPLOYED. RESISTANCE WAS NOTED DURING REMOVAL OF THE SESS. TROUBLESHOOTING WAS PERFORMED; THE INTRODUCER SHEATH HAD TO BE PULLED BACK AND THE STENT DEPLOYED BUT WAS ELONGATED AND STRETCHED TO THE PREVIOUSLY IMPLANTED SUPERA STENT, WHICH WAS DIFFICULT TO VISUALIZE. THE TIP OF THE SUPERA DETACHED IN THE SFA BUT REMAINED ON THE GUIDE WIRE. A BALLOON WAS USED TO AID IN REMOVAL OF THE TIP FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11387956 ↗
• MalfunctionDec 18, 2020Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT ON (B)(6) 2020, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE SUPERFICIAL FEMORAL ARTERY (SFA), WITH HEAVY CALCIFICATION AND 100% STENOSED, CONCENTRIC LESION. ACCESS WAS OBTAINED FROM THE CONTRALATERAL APPROACH. FOLLOWING PRE-DILATATION, A 6.0X120MM SUPERA STENT DELIVERY SYSTEM (SDS) ADVANCED TO THE LESION FOR IMPLANTATION. DURING DEPLOYMENT, THE STENT PARTIALLY DEPLOYED, APPROXIMATELY 2 CENTIMETERS, WHEN THE THUMB SLIDE WAS UNABLE TO SLIDE/MOVE ANYMORE. THE STENT WAS UNABLE TO DEPLOY ANY FURTHER. THE STENT WAS NOT DEPLOYED AND DEVICE REMOVED WITHOUT ISSUE. PER PHYSICIAN, THE ISSUE WITH THE 6.0X120 SUPERA DEVICE WAS POSSIBLY DUE TO THE ILIAC ARTERY CALCIFICATION AND TORTUOSITY. IT WAS DETERMINED THAT STENT DEPLOYMENT FROM THE CONTRALATERAL APPROACH WAS TOO DIFFICULT SO ANOTHER ACCESS SITE, ON THE IPSILATERAL SIDE WAS MADE. ANOTHER SUPERA STENT, A 6.0X80MM STENT, WAS IMPLANTED WITHOUT FURTHER ISSUES REPORTED. RESIDUAL STENOSIS WAS AT 10%. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11038203 ↗
• MalfunctionNov 26, 2020Difficult to Advance; Mechanical Jam; Activation Failure; Difficult to Advance; Mechanical Jam; Activation Failure

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE FIRST 6X150MM SUPERA STENT INITIALLY PARTIALLY DEPLOYED, THEN WITH MANIPULATED, THE STENT WAS FULLY DEPLOYED AT THE INTENDED SITE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10907606 ↗
• InjuryOct 15, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 6 X 120 MM SUPERA STENT WAS DEPLOYED WITHOUT ANY ISSUE; HOWEVER, DURING THE REMOVAL OF THE DELIVERY SYSTEM PER THE INSTRUCTION FOR USE (IFU), THE TIP MET RESISTANCE WITH THE ANATOMY AND BECAME SEPARATED. THE TIP REMAINED ON THE DELIVERY SYSTEM, BUT A SNARE DEVICE HAD TO BE USED TO PROPERLY REMOVE THE DELIVERY SYSTEM AND SEPARATED TIP THROUGH THE SHEATH. THE PATIENT IS FINE. 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 10685573 ↗
• InjuryOct 5, 2020Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  SUBSEQUENT TO THE INITIALLY FILED REPORT THE FOLLOWING INFORMATION WAS RECEIVED: THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS PRE-DILATED WITH A 6.0 BALLOON PRIOR TO DEPLOYMENT OF THE SUPERA SELF-EXPANDING STENT (SES). THERE WAS NO REPORTED RESISTANCE REMOVING THE SUPERA STENT SYSTEM. ANGIOGRAPHY SHOWED GOOD WALL APPOSITION AND NO POST-DILATATION WAS NEEDED. THE 3.0 ARMADA BALLOON WAS ADVANCED TO POSSIBLY TREAT THE TIBIAL ARTERY, BUT COULD NOT CROSS AND IT WAS OBSERVED VIA ADDITIONAL IMAGING THAT THE TIP OF THE SUPERA SES HAD DETACHED AND WAS BLOCKING THE PROXIMAL END OF THE SUPERA STENT. THE 3.0 ARMADA BALLOON WAS THEN USED TO RETRIEVE THE TIP OF THE SUPERA AND INADVERTENTLY REMOVED THE IMPLANTED STENT. NO ADDITIONAL TREATMENT WAS PERFORMED AND NO ADDITIONAL STENT WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10631779 ↗