SUPERA S-65-080-120-P6 (UDI 08717648226267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648226267), received between Feb 15, 2019 and Dec 19, 2023 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Off-Label Use; Difficult or Delayed Activation; Off-Label Use; Difficult or Delayed Activation

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A LESION IN THE LEFT ULNAR VEIN AND PERFORATOR VEIN. ANGIOPLASTY OF THE LESION WAS PERFORMED WITH A 4.0X15MM NON-COMPLAINT BALLOON FOLLOWED BY SERIAL DILATION WITH 6X40MM, 7X60MM [PERFORATOR VEIN] AND A 7X40MM [ULNAR VEIN] NON-ABBOTT BALLOONS. A 6.5X80MM SUPERA SELF-EXPANDING STENT DELIVERY SYSTEM (SES); WAS ADVANCED AND ATTEMPTED TO BE DEPLOYED. AFTER RELEASING 1/6 OF THE STENT, THE THUMBSILDE CONTINUED TO WORK; HOWEVER, NO FURTHER DEPLOYMENT OF THE STENT WAS NOTED. THE PHYSICIAN WIGGLED THE SES CATHETER AND THE STENT WAS ABLE TO BE SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. THERE WERE NO REPORTED 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 18361145 ↗
• MalfunctionSep 28, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS 6.5MM AND ATHERECTOMY WAS NOT USED. THE 6.5X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS NOTED TO HAVE PARTIALLY DEPLOYED IN THE SHEATH AND THE STENT WAS DRAGGED BACK INTO THE SHEATH. THE STENT AND SHEATH WERE REMOVED UNDER FLUOROSCOPY. THERE WAS NO PROBLEM WITH THE DEPLOYMENT MECHANISM. ANOTHER NON-ABBOTT STENT WAS USED TO COMPLETE 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 17836283 ↗
• InjuryDec 24, 2022Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY (CFA). THE CFA HAD A VESSEL DIAMETER OF 6.5X7.5MM AND THE EXTERNAL ILIAC ARTERY WAS 6.5X6.7MM. THE VESSEL WAS PREPARED BY USING A 7.0X70MM BALLOON WITH A NOMINAL PRESSURE OF 6ATMOSPHERES (ATMS) FOR A TOTAL OF 3 MINUTES. ATHERECTOMY WAS USED. THE 6.5X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) ADVANCED WITHOUT RESISTANCE AND SEEMED TO BE DEPLOYING FINE AND THE THUMBSLIDE WAS PUT BACK IN THE ORIGINAL POSITION AND LOCKED PROPERLY. IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE STENT EMERGED FROM THE SHEATH AND WAS FULLY RELEASED. UPON REMOVAL OF THE SESS UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THE STENT WAS PULLING BACK INTO THE SHEATH, HOWEVER, THE STENT WAS ABLE TO BE RELEASED FROM THE SYSTEM. THE SYSTEM WAS PULLED OUT WITH NO RESISTANCE NOTED. THE PHYSICIAN WENT BACK IN WITH A SHEATH DILATOR AND WAS ABLE TO MANIPULATE THE SHEATH AND THE DILATOR AND GET THE PROXIMAL PORTION OF THE STENT OFF OF THE SHEATH. THE DILATOR WAS THEN REMOVED. DURING REMOVAL OF THE SHEATH, THE PHYSICIAN ONLY PULLED BACK A COUPLE OF CENTIMETERS (CM) AND TOOK SOME IMAGES. THE PHYSICIAN THEN REMOVED THE WIRE AND IT WAS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16045800 ↗
• MalfunctionMay 23, 2022Mechanical Jam; Activation Failure; Mechanical Jam; 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. THE VESSEL DIAMETER WAS 6.5MM AND THE LESION LENGTH WAS 60MM. USING THE CROSS-OVER-APPROACH, THE VESSEL WAS PREPPED WITH BALLOON DILATATION AT 16 ATMOSPHERES (ATM) FOR 30 SECONDS. A 6.0X120MM SUPERA STENT AND A NON-ABBOTT 6.0X120MM STENT WERE IMPLANTED WITHOUT ISSUE. THEN THE 6.5X80MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND ATTEMPTED TO BE DEPLOYED; HOWEVER ONLY 2MM OF THE STENT WAS ABLE TO BE RELEASED FROM THE SHEATH. THE THUMBSLIDE WAS NOT ABLE TO BE ADVANCED. THEREFORE, THE SESS WAS REMOVED UNDER FLUOROSCOPY FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478075 ↗
• MalfunctionMar 9, 2022Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED VESSEL IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). ATHERECTOMY WAS NOT USED. AFTER DEPLOYMENT OF THE 6.5X80 SUPERA SELF EXPANDING STENT SYSTEM (SESS), THE STENT WAS CAUGHT ON THE DELIVERY CATHETER WHEN THE DEPLOYMENT SYSTEM WAS REMOVED AND THE STENT WAS REMOVED AS WELL. THE DELIVERY SYSTEM WAS NOT REMOVED UNDER FLUOROSCOPY. THERE WERE NO DEPLOYMENT MECHANISM ISSUES. THE PROCEDURE WAS ABORTED AT THAT POINT. 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 13715330 ↗
• InjuryJan 20, 2022Product Quality Problem; Difficult to Remove; Stretched; Product Quality Problem; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL DIAMETER WAS 6.3 MM AND ATHERECTOMY WAS NOT PERFORMED. PRE-DILATATION WAS PERFORMED WITH A 6X40 MM NON-ABBOTT BALLOON FOR 120 SECONDS AT 24 ATMOSPHERES TWICE. THE 6.5X40 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYED; HOWEVER, THE STENT BEGAN TO SHORTEN AND SLIP OUT OF PLACE FROM THE TARGET LESION DURING DEPLOYMENT. SOME OF THE STENT WENT INTO HEALTHY TISSUE WHILE SOME REMAINED IN THE TARGET LESION. THE PHYSICIAN STATED IT WAS POSSIBLE THE STENT MOVED DURING DEPLOYMENT. NEXT, A 6.5X80 MM SUPERA SESS WAS ADVANCED AND WAS DEPLOYED. HOWEVER, THE STENT ELONGATED WHEN THE DELIVERY SYSTEM WAS REMOVED AND SOME WENT INTO HEALTHY TISSUE, WHILE SOME REMAINED IN THE TARGET LESION. IT WAS ATTEMPTED TO RETRIEVE THE STENT USING A NON-ABBOTT SHEATH BUT THE DELIVERY SYSTEM WAS STUCK COMPLETELY AND FAILED TO REMOVE ALL OF THE STENT AND DELIVERY SYSTEM. THE TIP OF THE SUPERA IS DAMAGED. SURGERY WAS PERFORMED TO RETRIEVE THE DELIVERY SYSTEM, STENT AND THE FIRST IMPLANTED STENT AS WELL. FINAL PATIENT OUTCOME IS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 13308597 ↗
• InjurySep 22, 2021Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SHORT THROMBOTIC LESION FROM THE COMMON FEMORAL ARTERY (CFA) TO THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS A DE NOVO LESION WITH ECCENTRIC STENOSIS. THE VESSEL DIAMETER WAS 6.5MM, AND THE LESION LENGTH WAS 50MM. A TRANS ANKLE APPROACH WAS TAKEN AND PRE-DILATATION WAS PERFORMED. THE 6.5X80 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED FROM THE SFA OSTIUM TO CFA. THE THUMB SLIDE WAS PULLED BACK TO PROXIMAL SIDE AND THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED OUTSIDE THE PATIENT BODY; HOWEVER, IT WAS STUCK WITH THE SUPERA STENT. FORCE WAS APPLIED IN ATTEMPT TO REMOVE THE DELIVERY SYSTEM, AND THE THUMB SLIDE WAS PULLED BACK TO PROXIMAL SIDE; HOWEVER, THE NOSE CONE WAS STUCK TO THE PROXIMAL EDGE OF THE STENT. AT THIS POINT THE PHYSICIAN SUSPECTED PROXIMAL STENT EDGE MALAPPOSITION. THEREFORE, THE GUIDING SHEATH WAS ADVANCED TO BE CLOSE TO THE NOSE CONE, IT COVERED THE NOSE CONE AND THE SYSTEM WAS ABLE TO BE REMOVED FROM THE BODY. NEXT, A BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO DILATE AT THE PROXIMAL EDGE OF THE STENT, BUT THERE WAS RESISTANCE NEAR THE PROXIMAL EDGE OF THE STENT AND THE BDC COULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514552 ↗
• InjuryJul 7, 2021Material Separation; Activation Failure; Migration; Material Separation; Activation Failure; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT EXTERNAL ILIAC VEIN (EIV). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED DEVICE AND A 6.5X80MM SUPERA STENT WAS ADVANCED AND DEPLOYED. HOWEVER, THE STENT HAD DIFFICULTY DETACHING FROM THE STENT DELIVERY SYSTEM AS IT WAS ONLY PARTIALLY DEPLOYED. THE EDGE OF THE STENT DIDN'T DEPLOY. EVEN THOUGH THE THUMB SLIDE WAS ADVANCED/PULLED BACK, THE STENT DIDN'T RELEASE FROM THE DELIVERY SHAFT. AT SOME POINT DURING ATTEMPTED REMOVAL THE STENT DETACHED FROM THE SHAFT AND MIGRATED FROM THE LEFT EIV TO THE LEFT COMMON VEIN. THE STENT WAS NOTED TO BE DEPLOYED IN HEALTHY TISSUE. THE TIP OF THE DELIVERY CATHETER SEPARATED AND TREATMENT IF ANY IS UNKNOWN. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12131380 ↗
• InjuryJun 16, 2021Material Separation; Stretched; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A GREATER THAN 60% STENOSED, MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6.5X80MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE STENT DEPLOYED. UPON WITHDRAW OF THE DELIVERY SYSTEM, THE STENT ELONGATED EVEN THOUGH IT SHOWED AS RELEASED FROM THE DELIVERY SYSTEM ON FLUOROSCOPY. THEY CONTINUED TO REMOVE THE DELIVERY SYSTEM AND THE NOSE CONE COMPLETELY SEPARATED AND REMAINED IN THE ANATOMY. A BALLOON AND WIRE WERE USED TO TRAP THE NOSE CONE AND PULL IT INTO THE SHEATH, TO COMPLETELY REMOVE IT 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 12011313 ↗
• InjuryJun 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) TO EXTERNAL ILIAC ARTERY, VIA THE RIGHT COMMON FEMORAL ARTERY. A 6.0 X 45 NON-ABBOTT SHEATH WAS ADVANCED UP AND OVER TO THE TARGET LESION. PRE-DILATATION WAS PERFORMED USING A 5.0 X 80 MM DILATATION CATHETER OVER A 0.018 GUIDE WIRE. ADDITIONAL DILATATION WAS PERFORMED USING A DRUG COATED BALLOON. THE 6.5 X 80 MM SUPERA STENT DELIVERY SYSTEM WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION AND DEPLOYED WITHOUT ISSUE. AFTER STENT DEPLOYMENT, IT WAS NOTED THAT THE NOSE CONE HAD DETACHED. A 6.0 X 20 MM NON-ABBOTT DILATATION CATHETER WAS ADVANCED, IN AN ATTEMPT TO EMBED THE NOSE CONE INTO THE VESSEL WALL; HOWEVER, THE NOSE CONE EMBOLIZED TO A SMALL BRANCH OF THE PROFUNDA ARTERY. THE SEPARATED NOSE CONE REMAINS IN THE PATIENT ANATOMY AND THERE ARE NO PLANS TO REMOVE IT. THE PROCEDURE ENDED WITH THE PATIENT IN STABLE CONDITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 11924871 ↗
• MalfunctionApr 7, 2021Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 50% STENOSED LEFT SUPERFICIAL FEMORAL ARTERY. A COMMAND 18 GUIDE WIRE AND 7X40MM NON-ABBOTT BALLOON WERE USED FOR PRE-DILATATION. A 6.5X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITH A NON-ABBOTT 6F SHEATH, BUT THE STENT ONLY PARTIALLY DEPLOYED. DURING REMOVAL OF THE SESS, THE STENT RELEASED FROM THE SYSTEM AND WAS IMPLANTED BUT WAS NOTED TO BE STRETCHED AND ONLY PARTIALLY IN THE TARGET LESION. A 7X40MM NON-ABBOTT STENT WAS USED TO TREAT THE REMAINING PORTION OF THE LESION AND 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 11631074 ↗
• InjuryAug 7, 2020Material Separation; Material Separation

  INFORMATION RECEIVED VIA USER FACILITY MEDWATCH MW5095203 STATES: THE NOSE CONE OF THE SUPERA STENT BROKE OFF INTO THE LEFT EXTERNAL ILIAC ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10382321 ↗
• MalfunctionOct 17, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS PERFORMED AND THE LESION WAS PREPPED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. THE 6.5X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE, WHEN THE WHITE TIP BROKE JUST BEFORE DEPLOYMENT. THE SESS AND STENT WERE REMOVED WITHOUT ISSUES, AND A NEW 6.5X100 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 INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202850 ↗
• MalfunctionOct 10, 2019Stretched; Improper or Incorrect Procedure or Method; Activation Failure; Stretched; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 100% STENOSED AND MODERATELY CALCIFIED DE NOVO LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. FOLLOWING PRE-DILATATION, A 6.5X80MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED; HOWEVER, THE DELIVERY SYSTEM WAS REMOVED WITHOUT RELEASING THE DEPLOYMENT LOCK AND THE STENT PARTIALLY PULLED OUT TO THE COMMON FEMORAL ARTERY SIDE AND ELONGATED. THE STENT WAS REMOVED WITH THE SHEATH UNDER FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT STENT. THERE WERE 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 9177048 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 THE 6.5X80 MM SUPERA STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2019 PERCUTANEOUS REVASCULARIZATION WAS ATTEMPTED ON THE PATIENT TO TREAT SYMPTOMATIC RESTENOSIS IN THE SUPERA STENT, BUT THE STENT WAS UNABLE TO BE RE-CANNULATED DURING THE PROCEDURE. A FEMORAL POPLITEAL BYPASS SURGERY IS SCHEDULED TO TREAT THE CLAUDICATION AND RESTENOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Stenosis

  MAUDE report 8345829 ↗