SUPERA S-55-100-120-P6 (UDI 08717648226120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648226120), received between Aug 20, 2018 and Feb 26, 2025 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2025Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 5.5X100MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT WOULD ONLY PARTIALLY DEPLOY. THE STENT WAS NOTED TO BE STUCK IN THE SHEATH. THEREFORE, THE SHEATH WAS PULLED BACK AND THE STENT WAS NOTED TO BE IN THE PATIENT'S LEFT GROIN AND PARTIALLY OUTSIDE THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND CUTDOWN SURGERY WAS PERFORMED TO REMOVE THE STENT. BRUISING AND DISCOMFORT WAS NOTED BY THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THERE AS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 21471859 ↗
• MalfunctionJan 9, 2025Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. AFTER PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON DEVICE, THE 5.5X100MM SUPERA STENT SELF-EXPANDING SYSTEM (SSES) WAS ADVANCED THROUGH AN UNSPECIFIED 6FR 45CM SHEATH AND RESISTANCE WAS NOTED FROM THE ANATOMY. DEPLOYMENT WAS ATTEMPTED YET THE STENT PARTIALLY DEPLOYED. THE SESS WAS REMOVED UNDER FLUOROSCOPY WITHOUT ISSUE. A NEW SUPERA SSES WAS USED TO CONTINUE 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 21113793 ↗
• MalfunctionOct 19, 2022Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT SUPERIOR FEMORAL ARTERY (SFA). TWO UNSPECIFIED SUPERA SELF-EXPANDING STENT WERE IMPLANTED WITHOUT ISSUE. THE THIRD 5.5X100MM SUPERA STENT MET RESISTANCE WITH THE 6FR SHEATH DURING ADVANCEMENT AND REMOVAL. THE SUPERA DEVICE WAS REMOVED AND THE SHAFT WAS NOTED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE AND NEW SUPERA STENT. 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 15634017 ↗
• MalfunctionJun 17, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION. DURING DEPLOYMENT OF THE SUPERA STENT, THE RATCHET MECHANISM DID NOT PUSH THE STENT FORWARD; IT DID NOT SEEM TO BE ENGAGING APPROPRIATELY. THE PHYSICIAN MADE CONTINUED ATTEMPTS, AND THE SUPERA STENT WAS FINALLY ABLE TO BE DEPLOYED. IT WAS NOTED THAT THE STENT WAS IMPLANTED MORE PROXIMAL THAN WAS DESIRED, AND EXTENDED INTO THE PROFUNDA ARTERY. THE TARGET LESION WAS FULLY COVERED. POST DILATATION WAS PERFORMED PER STANDARD PROTOCOL. NO ADDITIONAL INTERVENTION WAS PERFORMED. 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 14739457 ↗
• MalfunctionMar 9, 2022Difficult to Remove; Stretched; Material Twisted/Bent; Activation Failure; Difficult to Remove; Stretched; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED FOR A RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE TORTUOSITY AND CALCIFICATION. FOR VESSEL PREPARATION, ATHERECTOMY WAS PERFORMED USING A PHOENIX CATHETER, AND TWO BALLOON DILATATION CATHETERS WERE SUCCESSFULLY UTILIZED. THE SUPERA STENT DELIVER SYSTEM ADVANCED TO THE LESION SITE WITHOUT ISSUES REPORTED. STENT DEPLOYMENT WAS PERFORMED WITH SUCCESSFUL WALL APPOSITION. DURING DELIVERY SYSTEM REMOVAL, THE SUPERA TIP (NOSE CONE) CAUGHT THE DEPLOYED STENTS EDGE. THE NOSE CONE SITE HAD BENT AND HAD GRABBED THE STENTS PROXIMAL EDGE. DURING DEVICE RETRACTION, THE STENT ELONGATED WITH THE ENTANGLED NOSE CONE, AND WAS EXPLANTED. THE NOSE CONE HAD NOT SEPARATED FROM THE DEVICE AND ALL WAS REMOVED FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. ANOTHER DEVICE (NON-ABBOTT) WAS USED IN REPLACEMENT WITHOUT FURTHER ISSUES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712489 ↗
• MalfunctionJan 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SUPERA STENT DELIVERY SYSTEM WAS BEING PREPPED PER INSTRUCTIONS FOR USE (IFU). WHILE WIPING THE DISTAL OUTER SHEATH PER INSTRUCTIONS, THE NOSE CONE (TIP) SEPARATED FROM THE DEVICE. THERE WAS NO UNUSUAL RESISTANCE OR APPLIED EXCESSIVE FORCE NOTED. THE DEVICE WAS DISCARDED AND NOT USED. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SUPERA DEVICE WAS SUCCESSFULLY USED IN REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13350975 ↗
• MalfunctionJan 12, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH MILD CALCIFICATION. THE VESSEL DIAMETER WAS 5.5 MM AND ATHERECTOMY WAS NOT USED. PRE-DILATATION WAS PERFORMED WITH A 5.5X100 MM AMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER AT 8 ATMOSPHERES FOR 3 TO 5 MINUTES. THE 5.5X120 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED BUT THE STENT ONLY PARTIALLY DEPLOYED IN THE LESION. THEREFORE, THE STENT AND DELIVERY SYSTEM WERE REMOVED AND A NEW, SAME SIZE SUPERA SESS 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 13236690 ↗
• MalfunctionNov 18, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.50X100MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND DEPLOYED AT THE LESION WITHOUT ISSUE. POST DEPLOYMENT WHEN REMOVING THE GUIDE WIRE, THE PATIENTS LEG TWITCHED, CAUSING THE GUIDE WIRE TO PULL THE IMPLANTED STENT BACK TO THE SHEATH. THE STENT WAS EASILY REMOVED FROM THE PATIENT. ANOTHER STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836948 ↗
• MalfunctionJan 25, 2021Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SUPERFICIAL FEMORAL ARTERY. THE 5.5X100MM SUPERA SELF-EXPANDING STENT SYSTEM WOULD NOT LOAD ON A 0.014-INCH COMMAND GUIDE WIRE. THE SUPERA TIP WAS THEN NOTED TO BE LOOSE BUT NOT SEPARATED. A NEW 5.5X80MM SUPERA WAS USED SUCCESSFULLY WITH THE SAME GUIDE WIRE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11224301 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS ARTICLE, TITLED, "ANGIOSCOPIC FINDINGS ON 15-MONTH FOLLOW-UP FOR INTERWOVEN NITINOL STENT INVAGINATION IN THE FEMOROPOPLITEAL ARTERY", IS A FOLLOW-UP TO AN EARLIER ARTICLE, TITLED, "INVAGINATION OF AN INTERWOVEN NITINOL STENT DURING FEMOROPOPLITEAL PLACEMENT". THE EARLIER ARTICLE WAS PREVIOUSLY FILED IN MFR REPORT# 2024168-2020-01777. THE NEW INFORMATION FOUND IN THE CURRENT ARTICLE IS THAT THE PATIENT WILL BE KEPT ON LIFELONG DAPT TO PREVENT STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462802 ↗
• InjuryApr 22, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, CONCENTRIC, DE NOVO, DISTAL SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS DONE WITH A 5.5X80MM NON-ABBOTT BALLOON AT 18 ATM FOR 60 SECONDS. THE 5.5X100MM SUPERA STENT WAS SUCCESSFULLY IMPLANTED. THE THUMB SLIDE WAS LOCKED BEFORE THE DELIVERY SYSTEM WAS WITHDRAWN. THE DELIVERY SYSTEM WAS REMOVED WITH RESISTANCE. THE PHYSICIAN WAS UNSURE IF THE RESISTANCE WAS WITH THE STENT OR SOMETHING ELSE. IT WAS THEN NOTED THAT THE TIP HAD SEPARATED AND REMAINED ON THE GUIDE WIRE. POST-DILATATION WAS PERFORMED THEN THE TIP WAS RETRIEVED USING A SNARE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986401 ↗
• InjuryFeb 26, 2020Difficult or Delayed Activation; Material Deformation; Difficult or Delayed Activation; Material Deformation

  IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE SUPERA STENT THAT MAY BE RELATED TO STENT INVAGINATION AND DIFFICULT DEPLOYMENT DUE TO THE COMPLEX DEPLOYMENT SYSTEM. THE PHYSICIAN APPLIED EXCESSIVE PUSH OF THE DEPLOYMENT CATHETER TO AVOID STENT ELONGATION, BUT THIS MAY HAVE CONTRIBUTED TO THE STENT INVAGINATION. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED, "INVAGINATION OF AN INTERWOVEN NITINOL STENT DURING FEMOROPOPLITEAL PLACEMENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756436 ↗
• MalfunctionFeb 12, 2020Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE COMMON FEMORAL ARTERY THAT WAS NON TORTUOUS, NON-CALCIFIED AND 70% STENOSED. THE SUPERA STENT WAS DEPLOYED WITHOUT ISSUE; HOWEVER, DURING REMOVAL OF THE STENT DELIVERY SYSTEM, IT WAS NOTED THAT THE TIP DETACHED AND REMAINED IN THE INTRODUCER AND THE PROXIMAL STENT WAS ATTACHED TO THE DELIVERY SYSTEM. THE STENT WAS REMOVED WITH THE DELIVERY SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL TREATMENT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702870 ↗
• MalfunctionOct 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING UNPACKING OF THE EMBOSHIELD NAV6, THE NOSE CONE WAS NOTED TO BE SEPARATED FROM THE DEVICE. THERE WAS NO RESISTANCE NOTED DURING WITHDRAWAL OF THE DEVICE FROM THE PACKAGE. THE DEVICE WAS NOT USED IN THE PATIENT ANATOMY. 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 9245495 ↗
• MalfunctionOct 22, 2019Difficult or Delayed Activation; Mechanical Jam; Difficult or Delayed Activation; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS TREATMENT OF A RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), HEAVILY CALCIFIED LESION. VESSEL PREPARATION WAS PERFORMED PER INSTRUCTIONS FOR USE. PRE-DILATATION WAS PERFORMED WITH A 5.5X100 BALLOON. THE SUPERA STENT DELIVERY SYSTEM (SDS) ADVANCED TO THE LESION AND THE STENT DEPLOYMENT STARTED WITHOUT ISSUE. ONCE AT THE END OF THE DEPLOYMENT, THE 2ND LOCK WAS ATTEMPTED TO BE UNLOCKED FOR A FULL PUSH THROUGH AND STENT RELEASE, HOWEVER THE LOCK WOULD NOT UNLOCK. AS TROUBLESHOOTING, THE DELIVERY SYSTEM WAS ANGULATED TO THE RIGHT AND LEFT AT 45 DEGREES, THE THUMBSLIDE WAS ADVANCED AND RETRACTED SEVERAL TIMES, HOWEVER, THE SECOND LOCK WOULD NOT UNLOCK. THE SHEATH WAS SLOWLY RETRACTED AND THE STENT FINALLY RELEASED. THE STENT REMAINED IMPLANTED AT THE INTENDED AREA. THERE WAS NO STENT STRETCHING OBSERVED. THERE WAS NO ADVERSE PATIENT EFFECT. A 30-MINUTE DELAY OCCURRED FOR TROUBLESHOOTING, HOWEVER, THERE WERE NO CLINICAL SYMPTOMS ASSOCIATED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9221883 ↗
• MalfunctionOct 8, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE 5.5X100 MM SUPERA STENT WAS MOSTLY DEPLOYED IN THE POPLITEAL ARTERY. REPORTEDLY, THE THUMB SLIDE WAS ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE BEFORE THE STENT DELIVERY SYSTEM (SDS) WAS RETRACTED FROM THE PATIENT. DURING REMOVAL OF THE SDS, THE STENT CAME OUT WITH THE SDS. THERE WAS NO INJURY TO THE POPLITEAL ARTERY. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE IN THE POPLITEAL ARTERY AS THAT IS THE STENT THE PHYSICIAN PREFERS TO USE. 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 9166013 ↗
• InjuryAug 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED ON (B)(6) 2017 WAS TO TREAT A LESION WITH MODERATE CALCIFICATION IN THE PROXIMAL POPLITEAL AND DISTAL SUPERFICIAL FEMORAL ARTERY. A 5.5 X 100 MM SUPERA STENT WAS IMPLANTED SUCCESSFULLY. ON (B)(6) 2018, THE PATIENT WAS EXPERIENCING CLAUDICATION. ANGIOGRAPHY REVEALED THAT THE PROXIMAL END OF THE SUPERA STENT WAS CRUSHED. ON (B)(6) 2018, THE PATIENT WAS TREATED WITH LASER ATHERECTOMY, BALLOONING AND ANOTHER SUPERA STENT WAS IMPLANTED AT THE PROXIMAL POPLITEAL, PROXIMAL OF THE SUPERA IMPLANT ANGIOGRAPHY CONFIRMED GOOD RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication

  MAUDE report 7799174 ↗