SUPERA S-50-080-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648211751), received between Jul 14, 2017 and Aug 18, 2025 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0X80MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED OVER AN UNSPECIFIED 0.014" GUIDE WIRE. THE STENT WAS DEPLOYED; HOWEVER, DURING REMOVAL OF THE SESS, THE STENT DID NOT RELEASE AND WAS PULLED BACK INTO THE 6F SHEATH. THE REQUIRED SIZE OF A STENT WAS NOT AVAILABLE SO TWO SUPERA STENTS WERE 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 22833445 ↗
• InjuryNov 6, 2024Stretched; Difficult or Delayed Activation; Mechanical Jam; Stretched; Difficult or Delayed Activation; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), WITH A VESSEL DIAMETER OF 5MM. AFTER PRE-DILATATION TO 8ATM, WITH A 5MM UNKNOWN BALLOON CATHETER, A 5X80MM SUPERA PERIPHERAL SELF EXPANDING STENT (SES) WAS ADVANCED THROUGH A 6F SHEATH AND WAS ATTEMPTED TO BE DEPLOYED AT THE LESION; HOWEVER, THE STENT COULD ONLY BE FOUR-FIFTHS OF THE WAY DEPLOYED AFTER SEVERAL ATTEMPTS TO PUSH THE THUMB SLIDER. THE PHYSICIAN DECIDED TO OPEN THE HANDLE IN ORDER TO RELEASE THE LATCH BUT WAS STILL UNABLE TO DEPLOY THE STENT. THE SES WAS FORCIBLY PULLED OUT, CAUSING THE STENT TO STRETCH AND DEFORM INSIDE THE ANATOMY, WITH PART OF THE STENT AT THE TARGET LESION AND PART REMAINING IN HEALTHY TISSUE. A NON-ABBOTT DILATATION BALLOON WAS USED TO TREAT THE STRETCHED AND DEFORMED STENT, 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 20619749 ↗
• MalfunctionNov 4, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFIICAL FEMORAL ARTERY THAT IS 90% OCCLUDED. THE LESION WAS PREPPED WITH LASER AND PRE-DILATATION WITH A 5MM UNSPECIFIED BALLOON. WHEN ATTEMPTING TO DEPLOY THE 5.0X80MM SUPERA SELF-EXPANDING STENT, GRIP WAS LOST ON THE SHAFT OF THE DEVICE AND THE STENT JUMPED DISTAL DUE TO TENSION. THEREFORE, A SECOND SUPERA STENT WAS DEPLOYED TO TREAT THE REST OF THE LESION. THERE WAS 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 20599120 ↗
• InjurySep 20, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. A 5X120MM SUPERA STENT WAS DEPLOYED AT THE TARGET LESION WITHOUT ISSUE. THEN, A 5X80MM SUPERA STENT WAS ADVANCED TO THE TARGET LESION TO BE OVERLAPPED WITH THE INITIAL STENT THAT HAD BEEN IMPLANTED. IT WAS NOTED THAT THE PATIENT WAS IN PAIN AND MOVING CONSTANTLY. THE PAIN WAS TREATED WITH MEDICATION AND IT WAS THOUGHT THAT THE STENT WAS DEPLOYED. DURING REMOVAL OF THE STENT SYSTEM, IT WAS OBSERVED THAT THE STENT WAS BEING REMOVED WITH THE DELIVERY SYSTEM. AT THIS POINT FLUOROSCOPY WAS USED TO CONTINUE THE PROCEDURE. EXTRAVASATION WAS NOTED AND THE PROCEDURE WAS DISCONTINUED AT THE PATIENT'S REQUEST. THE PATIENT WAS PLACED IN THE POST OPERATIVE OFFICE BASED LAB (OBL) AND DISCHARGED SOON AFTER. A FEW HOURS LATER, THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL. AT THE HOSPITAL THE PATIENT PRESENTED WITH A PSEUDOANEURYSM WHICH WAS TREATED WITH MEDICATION. AFTER OVERNIGHT OBSERVATION, THE PATIENT WAS DISCHARGED AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Pseudoaneurysm

  MAUDE report 20271368 ↗
• MalfunctionDec 5, 2023Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION FROM THE POPLITEAL TO SUPERFICIAL FEMORAL ARTERIES WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE LESION SIZE WAS 6X130 MM. A GUIDE WIRE CROSSED THE LESION AND PRE-DILATATION WAS PERFORMED WITH A 6X120 MM NON-ABBOTT BALLOON AT 20 ATMOSPHERES FOR 30 SECONDS THREE TIMES. DURING DEPLOYMENT OF THE 5.0X80 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), THE THUMBSLIDE BECAME HEAVY SO DEPLOYMENT WAS DISCONTINUED AND THE SUPERA SESS WAS REMOVED FROM THE ANATOMY PARTIALLY DEPLOYED. UPON REMOVAL FROM THE ANATOMY, THE THUMBWHEEL WAS TURNED AND THE STENT WAS DEPLOYED. A 5.5X80 MM SUPERA STENT WAS USED AS A REPLACEMENT AND A 6.0X80 MM SUPERA STENT WAS DEPLOYED PROXIMALLY AND THE STENTS OVERLAPPED. POST DILATATION WAS PERFORMED 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 18271817 ↗
• MalfunctionApr 21, 2022Activation Failure; Activation Failure

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14175548 ↗
• InjuryDec 22, 2021Adverse 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 DE NOVO, MILDLY CALCIFIED AND MILDLY TORTUOUS VESSEL IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS 5.0MM. PRE-DILATATION WAS NOT PERFORMED AND ATHERECTOMY WAS NOT USED. BECAUSE THERE WAS A LESION IN BOTH (LEFT AND RIGHT) VESSELS, PUNCTURE WAS DONE ANTEGRADELY FROM LEFT SFA AND A 5.0X80MM SUPERA SELF EXPANDING STENT WAS IMPLANTED IN LEFT SFA. THEN, APPROACH WAS CHANGED TO CROSS-OVER APPROACH TECHNIQUE, TOTAL OCCLUDED LESION AT RIGHT POPLITEAL VESSEL WAS ATTEMPTED TO BE TREATED. A GUIDE WIRE WAS ATTEMPTED TO CROSS THE LESION, BUT IT FAILED TO CROSS. WHEN THE LAST FLUOROGRAPHY WAS DONE, DISSECTION AT LEFT SFA WAS NOTED. THE 5.0X40MM SUPERA SESS WAS IMPLANTED TO TREAT THE DISSECTION BUT THE STENT BECAME ELONGATED [STRETCHED] BECAUSE OF NO PRE-DILATATION. THERE WAS NO RESISTANCE DURING ADVANCEMENT. POST-DILATATION WAS PERFORMED TO TREAT THE DISSECTION. HOWEVER, IT WAS NOTED THAT THE TIP OF THE SESS HAD SEPARATED AND REMAINED IN THE PATIENT'S BODY FLOATING FREELY DISTAL OF THE STENT AT SFA BUT NO BLOOD FLOW DISTAL OF P1. THE THUMB SLIDE WAS NOT FULLY RETRACTED TO THE START POSITION AND BOTH THE SYSTEM AND DEPLOYMENT LEV

  Patient problems: Vascular Dissection

  MAUDE report 13061389 ↗
• InjuryNov 15, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS 100% STENOSED. USING A CROSSOVER TECHNIQUE FROM THE RIGHT SFA A 5.0X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED AT THE DISTAL PART OF THE LESION. A 5.0X80MM SUPERA SESS WAS ATTEMPTED TO BE DEPLOYED MID LESION; HOWEVER, RESISTANCE WAS NOTED WITH THE THUMBSLIDE AND THE TIP OF THE SUPERA STUCK TO THE PREVIOUS IMPLANTED STENT. EXCESSIVE FORCE WAS APPLIED AND THE TIP SEPARATED. THE SEPARATED TIP WAS RETRIEVED AND DEVICE WAS REMOVED FORM THE ANATOMY. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813707 ↗
• MalfunctionSep 28, 2021Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO AND MODERATELY CALCIFIED CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ATHERECTOMY WAS NOT PERFORMED. PRE-DILATATION WAS PERFORMED USING A 5MM NON-ABBOTT BALLOON DILATATION CATHETER PRESSURIZED AT 20 ATMOSPHERES FOR 60 SECONDS. THE 5.0X80MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) REACHED THE DISTAL PART OF THE LESION AND DURING DEPLOYMENT, RESISTANCE WAS FELT WITH THE THUMBSLIDE. THE STENT PARTIALLY DEPLOYED, HOWEVER, IT WAS EASILY RETRIEVED ON THE SESS. ANOTHER 5.5X120MM SUPERA SESS WAS IMPLANTED AT THE DISTAL PART OF THE LESION AND NON-ABBOTT STENT AT THE PROXIMAL PART OF THE LESION. AFTER THE PROCEDURE, THE PATIENT TOOK A SUDDEN TURN FOR THE WORSE AND DIED. IT IS THE PHYSICIAN¿S OPINION THAT THE DEATH WAS NOT RELATED TO THE SUPERA DEVICE OR THE PROCEDURE AND WAS RELATED TO A PRIMARY DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544369 ↗
• MalfunctionMar 7, 2021Stretched; Difficult or Delayed Activation; Defective Device; Stretched; Difficult or Delayed Activation; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO MODERATELY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY THAT WAS 90% STENOSED. THE LESION WAS DILATED USING A 5X40MM NON-ABBOTT BALLOON AT 14 ATMOSPHERES (ATM) AND A 5X40MM NON-ABBOTT HP BALLOON AT 20 ATM. THEN A 5X80MM SUPERA STENT WAS ATTEMPTED TO DEPLOY, BUT THE STENT IMPLANT ONLY PARTIALLY DEPLOYED ALTHOUGH THE THUMBSLIDE WAS ABLE TO MOVE DURING THE ATTEMPTED DEPLOYMENT. THUS, THE DEPLOYMENT LOCK WAS UNLOCKED, THE THUMBSLIDE MOVED, BUT THE STENT STILL FAILED TO FULLY DEPLOY THE LAST 2 CM OF THE IMPLANT. FINALLY, THE SHAFT WAS PULLED IN AN ATTEMPT TO DEPLOY AND THE REST OF THE STENT IMPLANT, WHICH WAS ULTIMATELY SUCCESSFUL AND DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. ONCE IMPLANTED IT WAS NOTED THAT THE DISTAL PART OF THE IMPLANTED STENT WAS SHORTENED FROM THE FIRST HALF OF DEPLOYMENT, AND THE PROXIMAL PART OF IMPLANTED STENT WAS ELONGATED FROM THE PULLING OF THE SHAFT. OVERALL, THE IMPLANTED STENT WAS SLIGHTLY SHORT IN COMPARISON TO THE LESION. THERE WAS NO PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426852 ↗
• MalfunctionOct 23, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION FROM THE SUPERFICIAL FEMORAL ARTERY TO THE P1 SEGMENT. A CROSS OVER APPROACH FROM FEMORAL WAS PERFORMED. A GUIDE WIRE WAS CROSSED TO THE LESION, PRE-DILATATION WAS PERFORMED, AND THEN A 5X80MM SUPERA WAS ATTEMPTED TO DEPLOY. THE THUMBSLIDE WAS FULLY ADVANCED, THEN THE DEPLOYMENT LOCK WAS UNLOCKED AND THE STENT WAS DEPLOYED. WHEN THE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED UNDER FLUOROSCOPY, THE STENT IMPLANT MOVED PROXIMAL AND A PART OF THE STENT MOVED INTO THE SHEATH. IT WAS DECIDED TO REMOVE THE ENTIRE SYSTEM INCLUDING THE STENT IMPLANT WITH THE SHEATH. THE SHEATH WAS CHANGED AND A NEW 5X100MM SUPERA AND NON-ABBOTT STENT WERE IMPLANTED 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 Consequences Or Impact To Patient

  MAUDE report 10730448 ↗
• MalfunctionSep 24, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED AND MODERATELY CALCIFIED DE NOVO LESION IN THE RIGHT POPLITEAL ARTERY. THE NON-ABBOTT EMBOLIC PROTECTION FILTER WIRE WAS UNABLE TO BE REMOVED FROM THE 5.0X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) AFTER DEPLOYMENT. THE STENT DELIVERY SYSTEM AND THE WIRE WERE REMOVED AS ONE UNIT. THERE WAS NO REPORTED 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 10580855 ↗
• MalfunctionSep 23, 2020Premature Activation; Failure to Advance; Difficult to Advance; Premature Activation; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED AND HEAVILY CALCIFIED LESION IN THE RIGHT POPLITEAL ARTERY. A 5.0X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE; HOWEVER, RESISTANCE WITH THE GUIDE WIRE AND THE ANATOMY WAS FELT. THE SESS WERE REMOVED UNDER FLUOROSCOPY WITHOUT ISSUES. ONCE OUTSIDE THE PATIENT, IT WAS NOTED THAT APPROXIMATELY 10MM OF THE STENT HAD DEPLOYED/WAS OUTSIDE THE DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ANGIOPLASTY. 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 10577490 ↗
• MalfunctionMay 5, 2020Difficult or Delayed Positioning; Mechanical Jam; Activation Failure; Difficult or Delayed Positioning; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 5MM DIAMETER, 80MM LENGTH, ECCENTRIC, DE NOVO, MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS POPLITEAL TO DISTAL SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS NOT PERFORMED AND THE VESSEL WAS PREPARED WITH A 5 MM BALLOON AT 8 ATM FOR 60 SECONDS. A 6FR 25 CM SHEATH WAS USED. THE 5.0X80 MM SUPERA 6FR SELF EXPANDING STENT (SES) WAS ATTEMPTED TO BE DEPLOYED BUT IT WAS DIFFICULT TO CONFIRM THE PROXIMAL PORTION OF THE STENT DUE TO AN OVERLAP WITH A PREVIOUSLY IMPLANTED NON-ABBOTT STENT. THE PHYSICIAN DEEMED THE SUPERA SES HAD BEEN RELEASED VIA FLUOROSCOPY; THEREFORE, THE DELIVERY SYSTEM WAS REMOVED. THE SES HAD NOT COMPLETELY RELEASED HOWEVER, AND THE STENT MOVED WITH THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS THEN REMOVED VERY CAREFULLY AND SLOWLY WITH THE STENT. A NEW, SAME SIZE SUPERA SES WAS ABLE TO BE SUCCESSFULLY IMPLANTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN COMMENTED THAT THE THUMBWHEEL SHOULD HAVE SLID MORE DISTAL DURING RELEASING OF THE STENT; HOWEVER, THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE WAS ADVANCED TO THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026139 ↗
• InjuryMar 26, 2020Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION IN POPLITEAL ARTERY. 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; AND WAS THOUGHT TO BE DEPLOYED. HOWEVER, DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE STENT WAS NOT DEPLOYED WHICH CAUSED THE NOSE CONE TO SEPARATE FROM THE DEVICE. THE SESS INCLUDING THE STENT WERE REMOVED. A SNARE DEVICE WAS USED TO RETRIEVE THE NOSE CONE SUCCESSFULLY. 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: No Consequences Or Impact To Patient

  MAUDE report 9886228 ↗
• MalfunctionMar 11, 2020Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RESTENOSED, PREVIOUSLY STENTED LESION LOCATED IN THE PROXIMAL POPLITEAL AND A DISTAL OCCLUSION. DUE TO PATIENT ANATOMY, VISUALIZATION WAS DIFFICULT. AFTER IT WAS THOUGHT THAT THE STENT WAS FULLY DEPLOYED, THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED; HOWEVER, THE STENT WAS ONLY PARTIALLY DEPLOYED AND DURING REMOVAL OF THE SDS, THE STENT WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER SUPERA WAS DEPLOYED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821692 ↗
• MalfunctionOct 21, 2019Improper or Incorrect Procedure or Method; Activation Failure; Migration; Improper or Incorrect Procedure or Method; Activation Failure; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL ARTERY. A 6FRX45CM SHEATH WAS ADVANCED AND THE LESION WAS PRE-DILATED WITH A 4MM UNSPECIFIED BALLOON DILATATION CATHETER AND ATHERECTOMY. A 5.0X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED; HOWEVER, HALF WAY THROUGH THE STENT DEPLOYMENT THE STENT JUMPED BACK TOWARDS THE DELIVERY SYSTEM. THE DEPLOYMENT LOCK WAS NOT UNLOCKED AND THE THUMB SLIDE WAS NOT ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE. IT WAS BELIEVED THAT IF THE DEPLOYMENT OF THE STENT CONTINUED, THE LESION WOULD HAVE BEEN MISSED; THEREFORE, THE STENT WAS REMOVED WITH THE SESS UNDER FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 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 9216577 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS, NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. THREE SUPERA STENTS (5.0X80MM, 5.0X60MM, AND 5.5X120MM) AND A NON-ABBOTT STENT WERE SUCCESSFULLY PLACED IN THE LESION. BLOOD FLOW WAS LIMITED AS ONLY A TRICKLE WAS NOTED THROUGH THE STENTS. A BLOCKAGE WAS SUSPECTED BUT UNABLE TO IDENTIFY OR CONFIRM AS THROMBUS. BYPASS SURGERY WAS DONE AS TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 8962094 ↗
• 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 5.0 X 80 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS REJECTED FOR FOREIGN MATERIAL IN THE PACKAGE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS ANALYSIS IDENTIFIED THAT THE FOREIGN MATERIAL WAS A MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 8587823 ↗
• MalfunctionSep 28, 2018Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Activation Failure; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED AND STENOSED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY TO THE PROXIMAL POPLITEAL ARTERY. THE LESION DIAMETER WAS 5.0 MM. A 6F SHEATH WAS PLACED AND THE LESION WAS PREPARED WITH AN UNSPECIFIED 5.0 MM BALLOON DILATATION CATHETER. THE BALLOON WAS NOT INFLATED TO NOMINAL PRESSURE AND THE VESSEL WAS DILATED TO APPROXIMATELY 4.6 MM. AN UNKNOWN SUPERA SELF EXPANDING STENT WAS SUCCESSFULLY IMPLANTED, BUT DID NOT FULLY COVER THE LESION; THEREFORE, AN ADDITIONAL 5.0 X 80 SUPERA SELF EXPANDING STENT WAS ADVANCED. THE STENT WAS DEPLOYED CLOSE TO THE INTRODUCER SHEATH AS A RESULT OF AN ANTEGRADE APPROACH. THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE WAS ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE. ELONGATION, GREATER THAN 10 PERCENT OF THE STENT WAS NOTED AND THE STENT PARTIALLY DEPLOYED IN THE INTRODUCER SHEATH. THE STENT WAS THEREFORE WITHDRAWN FROM THE ANATOMY WITH THE INTRODUCER SHEATH AGAINST RESISTANCE FROM THE ANATOMY. A SMALLER SUPERA STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920634 ↗
• MalfunctionApr 17, 2018Detachment Of Device Component; Positioning Failure; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY. THE VESSEL WAS PRE-DILATED WITH A 5.0 MM DRUG COATED BALLOON. A 6FX45CM GUIDE SHEATH WAS USED. DURING DEPLOYMENT OF THE 5 X 80 MM SUPERA STENT SYSTEM THE STENT DID NOT FULLY DEPLOY, IT PARTIALLY DEPLOYED. THE DEVICE WAS RETRACTED BACK INTO THE SHEATH AND RESISTANCE WAS FELT WITH THE SHEATH. THE NOSE CONE (TIP) BROKE OFF INSIDE THE SHEATH WHEN ATTEMPTING TO REMOVE THE DEVICE. THE DEVICE, TIP, AND SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT. THE DECISION WAS MADE TO DISCONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435936 ↗
• MalfunctionSep 1, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2017, A 5.0X80MM 6F 120CM SUPERA PERIPHERAL SELF-EXPANDING STENT WAS SUCCESSFULLY DEPLOYED IN A POPLITEAL ARTERY WITH NO ADVERSE PATIENT EFFECTS AND NO DEVICE DIFFICULTIES. ON (B)(6) 2017, IT WAS DISCOVERED THAT THE IMPLANTED STENT HAD EXPIRED ON (B)(6) 2017. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS TO DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6839613 ↗
• MalfunctionJul 14, 2017Positioning Failure; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POPLITEAL ARTERY THAT WAS HEAVILY TORTUOUS. FOLLOWING PRE-DILATATION, A SUPERA PERIPHERAL SELF EXPANDING STENT (SES) 5.0 X 80 6F 120 CM WAS DEPLOYED. IT WAS THOUGHT THAT THE ENTIRE STENT HAD COMPLETELY COME OUT OF THE SHEATH, HOWEVER IT DID NOT DETACH AND WHEN THE DEPLOYMENT SYSTEM WAS REMOVED FROM THE ANATOMY, THE STENT CAME WITH IT. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS NOT REMOVED UNDER FLUOROSCOPY. ANOTHER SUPERA SES WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6714410 ↗