SUPERA S-50-100-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648211768), received between Aug 30, 2016 and Feb 12, 2026 — classified as 11 injuries, 11 malfunctions.

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

• MalfunctionFeb 12, 2026Difficult to Remove; Difficult to Advance

  IT IS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 5X100MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE ADVANCED ON A 0.018 UNSPECIFIED GUIDE WIRE (GW); HOWEVER, THE SESS BECAME STUCK DURING ADVANCEMENT AND REMOVAL. THEREFORE, THE SHEATH, GUIDE CATHETER AND SESS WERE REMOVED AS A SINGLE UNIT. THE PROCEDURE WAS CONTINUED WITH AN UNSPECIFIED SAME SIZE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328977 ↗
• InjuryNov 18, 2025Stretched; Activation Failure; Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 30-40% STENOSED LESION IN THE RIGHT POPLITEAL ARTERY. AFTER THROMBECTOMY WAS PERFORMED, THE 5X100MM SUPER SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION. INITIALLY, THE STENT WOULD NOT RELEASE UPON ADVANCING THE THUMB SLIDE. HOWEVER, THE STENT WAS ULTIMATELY RELEASED FROM THE DELIVERY SHEATH. BUT THEN DURING REMOVAL OF THE DELIVERY SHEATH UNDER IMAGING THE STENT WAS NOTED TO BEING RETRACTED WITH THE DELIVERY SHEATH. THE STENT WAS PULLED TO THE MID SUPERFICIAL FEMORAL ARTERY (SFA), WHERE THE STENT BECAME IMPLANTED SLIGHTLY STRETCHED; HOWEVER, STILL PARTIALLY IN THE TARGET LESION AND PARTIALLY IN HEALTHY TISSUE. A 5X80MM SUPERA STENT WAS USED TO TREAT THE TARGET LESION AND ALSO OVERLAPPED THE STENT IN THE MID SFA TO ENSURE THE STENT WAS SECURED IN THE UNINTENDED LOCATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587827 ↗
• MalfunctionJul 22, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN OCCLUDED LESION IN THE RIGHT AXILLARY ARTERY. THE LESION WAS PRE-DILATED WITH A BALLOON CATHETER. THE 5.0X100MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER THE STENT WOULD NOT DETACH PROPERLY DURING DEPLOYMENT, IT APPEARED THE STENT DID NOT EXPAND HOWEVER THE STENT WAS ABLE TO EVENTUALLY BE DEPLOYED IN THE TARGET LESION. THERE WAS A DELAY IN THE PROCEDURE HOWEVER THERE WERE NO ADVERSE PATIENT EFFECTS THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563849 ↗
• MalfunctionJan 31, 2025Contamination /Decontamination Problem; Difficult to Advance; Contamination /Decontamination Problem; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND HEAVY TORTUOSITY. DURING PREPARATION OF THE 5X100 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), WHILE OUTSIDE THE ANATOMY WITH THE COMMAND 18 GUIDE WIRE, THE WIRE WAS UNABLE TO ADVANCE. TWO ADDITIONAL UNSPECIFIED WIRES WERE REPLACED BUT AGAIN THE DEVICES COULD NOT ADVANCE THROUGH THE DELIVERY SYSTEM. THE FRONT SEGMENT OF THE STENT WAS CUT OFF WHILE STILL OUTSIDE THE ANATOMY AS IT WAS SUSPECTED SOMETHING WAS BLOCKING THE DEVICE AND THEN A GUIDE WIRE COULD PASS THROUGH BUT THE STENT WAS EXPOSED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT 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 21285306 ↗
• InjuryFeb 13, 2024Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND 80% STENOSIS. ACCESS WAS OBTAINED FROM THE LEFT COMMON FEMORAL AND WENT UP AND OVER. THE VESSEL WAS 5 MM IN DIAMETER AND WAS PREPARED WITH A 5X100 MM NON-ABBOTT BALLOON. PRE-DILATATION WAS PERFORMED WITH A 5X120 NON-ABBOTT SERRATED BALLOON. DURING DEPLOYMENT OF THE 5X100 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), THE THUMBSLIDE FELT LIKE IT WAS STUCK AND THE STENT PARTIALLY FLOWERED. THE PHYSICIAN DID NOT FEEL COMFORTABLE WITH CONTINUING DEPLOYMENT AND THE DEVICE WAS REMOVED. A NON-ABBOTT STENT WAS DEPLOYED WITHOUT ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE TOP RATCHET EAR WAS SEPARATED AND NOT RETURNED. THERE IS THE POTENTIAL THE SEPARATED PIECE REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699956 ↗
• MalfunctionDec 26, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. THE 5.0X100MM SUPERA STENT WAS USED IN A PROCEDURE; HOWEVER, THE STENT WAS ONLY ABLE TO BE PARTIALLY DEPLOYED. THEREFORE, THE SUPERA DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SUPERA STENT WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395500 ↗
• MalfunctionFeb 3, 2023Difficult or Delayed Activation; Mechanical Jam; Difficult or Delayed Activation; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POPLITEAL TO DISTAL SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE THUMB SLIDE WAS NOT DEPLOYING THE STENT, SO THE HANDLE WAS PULLED BACKWARD WITH THE DISTAL GUIDE, DEPLOYING THE STENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300435 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5X100MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS IMPLANTED WITHOUT ISSUE TO TREAT A MILDLY CALCIFIED, 90% STENOSED LESION IN THE LEFT SUPERIOR FEMORAL ARTERY (SFA). ON (B)(6) 2022, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS AND HAD A REVASCULARIZATION PROCEDURE. ATHERECTOMY WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE FINAL PATIENT OUTCOME WAS SUCCESSFUL, THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 15677505 ↗
• InjuryApr 21, 2022Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A 5MM ARMADA BALLOON WAS USED FOR PREDILATATION. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES FOR THE DURATION OF 60 SECONDS. THE 5.0X80MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND PLACED AT THE TARGET LESION. THE STENT WAS DEPLOYED, HOWEVER DURING REMOVAL THE STENT CAME OUT. IT WAS NOT NOTED AT THE TIME BUT THE STENT HAD BEEN PARTIALLY DEPLOYED IN THE 6FR SHEATH. ULTIMATELY, THE DELIVERY SYSTEM AND STENT WERE ABLE TO BE SIMPLY WITHDRAWN FROM THE ANATOMY. THEN A 5.0X100MM SUPERA WAS THEN PLACED; HOWEVER AGAIN DURING REMOVAL OF THE SESS, PART OF THE STENT WAS DEPLOYED IN THE SHEATH. THE SHEATH WAS THEN PULLED BACK WHICH EXPOSED THE STENT AND DEPLOYMENT WAS ABLE TO BE COMPLETED. WHEN THE DELIVERY SYSTEM CAME OUT WITHOUT THE NOSE CONE, IT WAS CONFIRMED VIA FLUOROSCOPY THAT THE NOSE CONE REMAINED STUCK AT THE PROXIMAL EDGE OF THE IMPLANTED STENT. ATTEMPTS WERE MADE TO SNARE THE NOSE CONE HOWEVER WERE UNSUCCESSFUL. THE PATIENT REFUSED FURTHER INTERVENTION, THEREFORE THE PROCEDURE CONCLUDED. THE FLOW WITHIN THE STENT IMPLANT WAS NOT IMPACTED BY THE NOSE

  Patient problems: Foreign Body In Patient

  MAUDE report 14175639 ↗
• MalfunctionSep 20, 2021Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Material Deformation; Physical Resistance/Sticking; Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOSCLEROTIC OCCLUDED LONG LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATATION WAS PERFORMED WITH A 5X100 ARMADA 18 BALLOON FOR 3 MINUTES AT 12 ATMOSPHERES. TWO SUPERA WERE SELECTED TO TREAT THE LESION. THE FIRST 6X80MM SUPERA STENT WAS RELEASED IN THE DISTAL PART OF THE LESION WITHOUT ANY ISSUE. WHEN DEPLOYING THE SECOND 5X100MM SUPERA STENT IN THE PROXIMAL SFA, HALF OF THE SUPERA STENT WAS RELEASED AS THE SYSTEM LOCKING MECHANISM BECAME STUCK. THE PHYSICIAN APPLIED FORCE TO PULL THE DELIVERY SHEATH TO RELEASE THE STENT. AFTER SEVERAL ATTEMPTS, THE STENT WAS COMPLETELY RELEASED. HOWEVER THE 5X100MM SUPERA STENT WAS SEVERELY COMPRESSED AND STRETCHED WITHIN THE VESSEL. NO FURTHER INTERVENTION OR ACTIONS WERE PERFORMED AND THE PROCEDURE WAS COMPLETED. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. 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 12499796 ↗
• InjuryJun 3, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. POST-STENT IMPLANTATION, WHILE REMOVING THE DELIVERY SYSTEM OF A 5X100MM SUPERA RESISTANCE WAS MET WITH THE GUIDE WIRE WHEN THE NOSE CONE SEPARATED. THE SUPERA DELIVERY SYSTEM WAS ABLE TO BE REMOVED AND THEN A SNARE WAS USED TO RETRIEVE THE SEPARATED TIP. THERE WERE 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 11930395 ↗
• MalfunctionMay 14, 2021Stretched; Improper or Incorrect Procedure or Method; Activation Failure; Stretched; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A RIGHT SUPERFICIAL FEMORAL ARTERY. THE VESSEL DIAMETER WAS 5 MM. THE LESION WAS BALLOONED AND A 5.0X100MMX120CM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. STENT DEPLOYMENT WAS INITIATED; HOWEVER, THE STENT DID NOT FULLY DEPLOY, THE PROXIMAL END OF THE STENT STAYED IN THE DEVICE. THE USER INADVERTENTLY FORGOT TO UNLOCK THE DISTAL LEVER WHEN RELEASING THE STENT. WHEN RETRACTING THE SESS, THE STENT ELONGATED AND COMPLETELY CAME OUT WITH THE DEVICE. A NEW SUPERA WAS USED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828604 ↗
• InjuryMar 2, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Migration; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Migration

  IT WAS THE REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, NON-TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS NOT DONE. USING A 6F SHEATH, THE 5.0X100MM 6F SUPERA SELF-EXPANDING STENT SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. IT WAS CONFIRMED VIA FLUOROSCOPY THAT THE STENT HAD BEEN FULLY RELEASED WITHOUT ISSUE. THE THUMBSLIDE WAS NOT PULLED BACK AND THE TWO LOCKS WERE NOT LOCKED. DURING REMOVAL OF THE DELIVERY CATHETER, THE TIP SEPARATED AND THE STENT BECAME ENTANGLED WITH THE RATCHET. THE STENT WAS MOVED INTO THE ILIAC BIFURCATION. A SNARE DEVICE WAS USED TO REMOVE THE TIP AND STENT. A NEW SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11401530 ↗
• InjurySep 5, 2020Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TIBIOPERONEAL TRUNK. A 5.0X100MM SUPERA STENT WAS ADVANCED TO THE LESION AND DEPLOYED WITHOUT ISSUE. AFTER DEPLOYING THE STENT, THE LAST LOCK WAS UNLOCKED BUT THE STENT IMPLANT BECAME STUCK IN THE CATHETER TIP AND CONSEQUENTLY THE STENT WAS MOVED TO THE PROXIMAL PORTION OF THE ARTERY WHICH WAS HEALTHY TISSUE. POST-DILATATION WAS DONE ON THE SUPERA AND ANOTHER STENT WAS USED TO SUCCESSFULLY COVER THE REST OF THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10498033 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL POPLITEAL ARTERY. ON (B)(4) 2020, A SUPERA STENT WAS IMPLANTED WITHOUT ISSUE. ON AN UNSPECIFIED DATE, THE PATIENT BECAME SYMPTOMATIC WITH LEG PAIN. ON (B)(4) 2020, THE PATIENT WAS REHOSPITALIZED AND VIA ANGIOGRAPHY, AN OCCLUSION WAS NOTED. LASER ATHERECTOMY AND BALLOON ANGIOPLASTY WERE PERFORMED. THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Occlusion

  MAUDE report 10495196 ↗
• MalfunctionJun 1, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Activation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND PREVIOUSLY STENTED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 6FRX10CM SHEATH WAS ADVANCED AND THE 5.5MM VESSEL WAS PRE-DILATED WITH AN UNSPECIFIED 6.0 BALLOON CATHETER FOR 1 MINUTE AT 8 ATMOSPHERES AND WITH A LASER. A 5.0X100MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED. DURING DEPLOYMENT, THE DEPLOYMENT LOCK WAS OPENED, THE STENT DEPLOYED, THE SYSTEM LOCKED, AND THE SESS RETRIEVED; HOWEVER, RESISTANCE WAS FELT WHEN THE SESS REACHED THE SHEATH AND THE STENT WAS REMOVED INTACT ON THE END OF THE SESS. THE DELIVERY SYSTEM WAS NOT REMOVED UNDER FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 5X120MM SUPERA STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106776 ↗
• InjuryDec 10, 2019Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 100% STENOSED, CHRONIC TOTALLY OCCLUDED, AND MODERATELY CALCIFIED DE NOVO LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2019, A 5.0X120MM AND 5.0X100 SUPERA SELF-EXPANDING STENTS WERE IMPLANTED WITH A 3MM OVERLAP. ABOUT ONE WEEK POST-PROCEDURE, THE PATIENT FELT DISCOMFORT WITH PAIN AND COLD AT THE TIP OF THEIR RIGHT FOOT. ON (B)(6) 2019, AN X-RAY CONFIRMED THAT THE STENTS HAD MOVED AND WERE NO LONGER OVERLAPPING. A 5X60MM NON-ABBOTT STENT WAS SUCCESSFULLY DEPLOYED AT THE SECTION WERE THE SUPERA STENTS HAD PREVIOUSLY OVERLAPPED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 9446894 ↗
• MalfunctionOct 1, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE POPLITEAL VEIN. A 6X45MM SHEATH WAS ADVANCED AND THE LESION WAS PRE-DILATED WITH A 5X100MM NON-ABBOTT BALLOON CATHETER TO NOMINAL PRESSURE AND ATHERECTOMY. A 5.0X100MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) PARTIALLY DEPLOYED; HOWEVER, THE STENT WAS REMOVED WHEN THE DELIVERY SYSTEM WAS REMOVED. THE SESS WAS REMOVED UNDER FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142742 ↗
• MalfunctionSep 6, 2019Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE INFORMATION BELOW WAS CORRECTED: THE OPERATOR WAS ASKED IF BOTH LOCK LEVERS (SYSTEM AND DEPLOYMENT) WERE LOCKED DURING REMOVAL. IT WAS THEN DISCOVERED THEY HAD NOT BEEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8970988 ↗
• InjuryAug 30, 2019Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. FOLLOWING PRE-DILATATION WITH AN UNSPECIFIED BALLOON CATHETER, SCORING BALLOON AND ATHERECTOMY, A 5.0X100MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED. AN ATTEMPT TO REMOVE THE DELIVERY CATHETER UNDER FLUOROSCOPY WAS MADE; HOWEVER, RESISTANCE WITH THE CALCIUM IN THE VESSEL WAS FELT. ADDITIONALLY, THE DEPLOYMENT AND SYSTEM LOCKS WERE NOT LOCKED BEFORE ATTEMPTING TO REMOVE THE DELIVERY SYSTEM AND THE NOSE CONE SEPARATED. THE NOSE CONE COULD NOT BE RETRIEVED AND IT WAS EMBEDDED IN THE POPLITEAL ARTERY BY BALLOONING IT INTO THE CALCIUM. THE NOSE CONE IS NOT MOVING AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8952497 ↗
• InjuryJun 4, 2018Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT FOLLOWING PRE-DILATATION WITH A 5.0 BALLOON CATHETER FOR 2-3 MINUTES, A 4.5 SUPERA STENT WAS IMPLANTED IN THE DISTAL POPLITEAL LESION AND FOLLOWING A 5.0 SUPERA STENT WAS IMPLANTED MORE PROXIMAL WITH SOME OVERLAP. BOTH STENTS WERE IMPLANTED WITHOUT ISSUE WITH REPORTED PERFECT RESULTS AND BOTH WERE WELL APPOSED TO THE VESSEL WALL. FOLLOWING, A THROMBUS WAS OBSERVED WITHIN THE STENTS WITH TOTAL OCCLUSION. THE THROMBUS THEN EMBOLIZED DISTALLY AND A 6F CATHETER WAS USED IN ATTEMPT TO RETRIEVE THE THROMBUS. DURING REMOVAL OF THE CATHETER THROUGH THE STENTS, REPORTEDLY THE OPERATOR DID NOT VISUALIZE THE SHEATH DURING REMOVAL AND THE SHEATH CAUGHT THE 5.0 SUPERA STENT AND ELONGATED THE 5.0 STENT. THE STENTS REMAINED WELL APPOSED TO THE VESSEL WALL. ON (B)(6) 2018, A BYPASS WAS PERFORMED, LEAVING THE SUPERA STENTS WITHIN THE PATIENTS ANATOMY. THE PATIENT IS IN STABLE CONDITION WITHOUT FURTHER ISSUES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Thrombosis

  MAUDE report 7565670 ↗
• MalfunctionAug 30, 2016Inaccurate Delivery

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POPLITEAL ARTERY THAT WAS MODERATELY CALCIFIED. ATHERECTOMY AND PRE-DILATATION WAS PERFORMED TO PREPARE THE LESION FOR STENTING. THE 5.0 X 100 MM SUPERA STENT IMPLANT WAS DEPLOYED WITHOUT ISSUE; HOWEVER, THE STENT IMPLANT JUMPED FORWARD IN THE VESSEL AND WAS PARTIALLY IN HEALTHY TISSUE. THE PROXIMAL PART OF THE TARGET LESION WAS LEFT UNTREATED; THEREFORE, A SECOND SUPERA STENT WAS DEPLOYED SUCCESSFULLY FOR TREATMENT OF THE REMAINING LESION. 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 5915254 ↗