SUPERA S-55-060-120-P6 (UDI 08717648226083)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648226083), received between Oct 5, 2018 and Mar 18, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 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.

• MalfunctionMar 18, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. THE 5X5X60MM SUPERA SELF-EXPANDING STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE PROXIMAL PORTION OF THE STENT INADVERTENTLY DEPLOYED INSIDE THE GUIDING CATHETER. THE GUIDE CATHETER WAS WITHDRAWN WITH THE STENT INSIDE, AND THE PROCEDURE WAS ABORTED. 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 24632085 ↗
• MalfunctionSep 25, 2024Improper 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 RIGHT SFA AND POPLITEAL ARTERY. THE 5.5X60MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS USED WITH A 6FR SHEATH. THE STENT WAS DEPLOYED AND THE SESS WAS RETRACTED. ONCE THE SESS WAS REMOVED, IT WAS NOTED THAT THE STENT CAME BACK WITH THE SHEATH (REMAINED IN THE SHEATH); THEREFORE, A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 20305201 ↗
• MalfunctionJun 11, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER IS 7MM AND WAS PREPARED WITH AN UNSPECIFIED BALLOON. THE 5.5X60MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED WITHOUT ANY PROBLEM IN THE DEPLOYMENT MECHANISM; HOWEVER, THE NOSE CONE WAS NOT OBSERVED UNDER FLUOROSCOPY. THEREFORE, WHEN THE SUPERA STENT SYSTEM WAS RETRACTED IT WAS NOTED THAT THE STENT WAS RETRACTED BACK INTO THE 6F SHEATH. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETED 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 19512695 ↗
• MalfunctionMay 1, 2023Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS, MILD CALCIFICATION AND NO TORTUOSITY. THE VESSEL SIZE WAS BETWEEN 5-6MM IN DIAMETER AND A 5.0X60MM ARMADA 18 BALLOON WAS INFLATED FROM 8-14 ATMOSPHERES (ATMS) WITHOUT ISSUES. ATHERECTOMY WAS USED. THE 5.5X60MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION. THE ACCESS SITE WAS THE RIGHT GROIN. THE INTRODUCER SHEATH WAS ABOUT 10-11CM TO THE PROXIMAL END OF THE STENT DURING DEPLOYMENT. THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE. HOWEVER, THE STENT ONLY PARTIALLY DEPLOYED WHEN THERE WAS A THUMBSLIDE ISSUE AND WOULD NOT DEPLOY FURTHER. THERE WAS NO PORTION OF THE STENT THAT DEPLOYED INSIDE THE INTRODUCER. THE SYSTEM WAS REMOVED AND THE STENT WAS FLOWERED UPON REMOVAL BUT THERE WERE NO COMPLICATIONS. AN ABSOLUTE PRO STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED BIOLOGICAL MATERIALS NOTED ON THE STENT. THERE WERE ADDITIONAL BIOLOGICAL MATERIALS NOTED ON TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843657 ↗
• InjuryMar 2, 2023Break; Difficult to Remove; Stretched; Migration; Break; Difficult to Remove; Stretched; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL ARTERY. A 5.5X60MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED; HOWEVER, DURING REMOVAL OF THE SELF-EXPANDING STENT SYSTEM (SESS) RESISTANCE BETWEEN THE STENT AND TIP WAS FELT. AFTER SEVERAL ATTEMPTS THE SESS WAS ABLE TO BE REMOVED, BUT THE STENT ELONGATED AND MOVED APPROXIMATELY 5CM OUT OF THE TARGET LESION INTO THE FEMORAL ARTERY. IT WAS FURTHER REPORTED THAT THE HANDLE OF THE SYSTEM WAS OBSERVED TO BE DAMAGED WITH THE MIDDLE PART BEING OPEN. THE PROCEDURE WAS FINISHED AND NOTHING FURTHER WAS DONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16473997 ↗
• MalfunctionSep 2, 2022Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL ARTERY. THE LESION WAS PRE-TREATED WITH ANGIOPLASTY. THE 5.5 X 60 MM SUPERA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY AND THE STENT WAS DEPLOYED; HOWEVER, THE DEPLOYMENT LOCK WAS NOT UNLOCKED TO RELEASE THE STENT; THEREFORE, DURING REMOVAL OF THE STENT DELIVERY SYSTEM, THE STENT WAS REMOVED AS WELL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND SUPERA STENT WAS USED TO COMPLETE THE STENTING PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352736 ↗
• MalfunctionAug 17, 2022Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). A 5X100 MM SUPERA SELF EXPANDING STENT (SES) WAS IMPLANTED IN THE DISTAL SFA WITH NO ISSUES AND THEN A NON-ABBOTT SES WAS IMPLANTED AS WELL. WHEN ATTEMPTING TO DEPLOY THE 5.5X60 MM SUPERA SES, THE STENT COULD NOT BE RELEASED AS IT WAS STUCK IN THE DELIVERY SYSTEM. THE STENT WAS REMOVED WITH THE DELIVERY SYSTEM STILL ATTACHED. THERE WERE NO REPORTED 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 15242837 ↗
• InjuryJul 19, 2022Material Separation; Improper or Incorrect Procedure or Method; Material Deformation; Migration; Material Separation; Improper or Incorrect Procedure or Method; Material Deformation; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). A FIRST 5.5X80MM SUPERA STENT WAS IMPLANTED WITHOUT ISSUE. THEN A 5.5X60MM SUPERA STENT WAS IMPLANTED AT THE DISTAL SFA. DURING REMOVAL OF THE DELIVERY SYSTEM (UNDER NO FLUOROSCOPY) WHEN THE CATHETER WAS PULLED BACK, THE NOSECONE SNAGGED THE 5.5X60MM SUPERA STENT AND PULLED THE STENT INTO THE SHEATH AT WHICH POINT THE NOSECONE BROKE OFF AND WAS LODGED IN THE SHEATH WITH A PARTIAL AMOUNT OF THE STENT; ABOUT 1/4 OF THE STENT IMPLANT. NO RESISTANCE WAS FELT WHEN IT WAS PULLED BACK FAST (ALTHOUGH ADVISED TO PULL BACK SLOWLY). THE NOSECONE WAS PUSHED OUT OF SHEATH AND LANDED IN THE PROXIMAL SFA. THE DELIVERY SYSTEM WAS ULTIMATELY ABLE TO BE REMOVED AND THE 5.5X60MM SUPERA STENT NOW INADVERTENTLY MOVED TO THE PROXIMAL SFA. SEVERAL SNARE ATTEMPTS WERE MADE TO REMOVE THE NOSECONE (ABOUT 90 MINUTES) BUT WERE UNSUCCESSFUL. HOWEVER, THE SNARE DEVICE WAS ABLE TO STRAIGHTEN OUT (UN-INVAGINATE) THE 5.5X60MM SUPERA STENT AS IT HAD BEEN INVAGINATED ON ITSELF. ALTHOUGH THE STENT IMPLANT WAS SUPPOSED TO BE IN THE DISTAL SFA, IT HAD BEEN PULLED TO THE PROXIMAL SFA WHERE THE PHYSICIAN DEEMED IT FINE AS IT DID NOT LIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053540 ↗
• MalfunctionNov 15, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 100% STENOSED, CALCIFIED, MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL DIAMETER WAS 5 MM AND LASER ATHERECTOMY WAS USED. THE VESSEL WAS PREPARED WITH A 5 MM DRUG COATED BALLOON (DCB). THE 5.5X60 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) APPEARED TO FULLY DEPLOY THE STENT BUT IT COULD NOT BE RELEASED FROM THE DELIVERY SYSTEM. NO PORTION OF THE STENT WAS DEPLOYED IN THE INTRODUCER AND THE INTRODUCER SHEATH WAS ABOUT 40 CM FROM THE PROXIMAL END OF THE STENT DURING DEPLOYMENT. THE STENT WAS EASILY REMOVED BY REMOVING THE DEPLOYMENT CATHETER AND THEN PLACING ANOTHER STENT. 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 12813209 ↗
• MalfunctionNov 12, 2021Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY THAT WAS 90% STENOSED. TO PREPARE THE LESION A 5 MM BALLOON WAS USED TO EXPAND AT 6 ATMOSPHERES FOR 1 MINUTE. THEN A 5.5X60MM SUPERA STENT WAS ADVANCED TO THE LESION BUT COULD NOT BE RELEASED AS THE VESSEL WAS TOO TORTUOUS. THE THUMBSLIDE WAS ATTEMPTED TO BE ADVANCED BUT RESISTANCE WAS MET DURING ATTEMPTED DEPLOYMENT. THE DEVICE WAS REMOVED. IT WAS NOTED THAT A PORTION OF THE STENT DEPLOYED INSIDE THE INTRODUCER SHEATH. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, THE ACCOUNT CONFIRMED THAT THERE WAS NO PORTION OF THE STENT DEPLOYED INSIDE THE INTRODUCER SHEATH AS PREVIOUSLY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804137 ↗
• MalfunctionJun 22, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. AFTER LESION PRE-DILATATION WAS PERFORMED, THE DEVICE WAS ADVANCED TO THE LESION AND DEPLOYMENT OF THE 5.5 X 60 MM SUPERA STENT WAS INITIATED. AFTER PARTIAL DEPLOYMENT, THE SUPERA STENT APPEARED TO BECOME STUCK TO THE STENT DELIVERY SYSTEM; HOWEVER, THE STENT WAS ABLE TO BE DEPLOYED. THE STENT MOVED FROM THE DEPLOYED LOCATION, BUT REMAINED IN THE TARGET LESION. NO ADDITIONAL INTERVENTION WAS PERFORMED AND NO ADVERSE PATIENT EFFECT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046080 ↗
• InjuryMay 11, 2021Difficult to Remove; Material Separation; Activation Failure; Difficult to Remove; Material Separation; Activation Failure

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A SUPERA STENT WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, DURING DEPLOYMENT, THE STENT WAS UNABLE TO BE RELEASE. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, BUT WHEN THE STENT REACHED THE ANTERIOR TIBIAL BRANCH, IT DETACHED FROM THE DELIVERY SYSTEM. IT WAS NOTED THAT RESISTANCE WAS FELT WHEN THE STENT WAS PULLED INTO THE TIBIAL. NO TREATMENT WAS PERFORMED IN AN ATTEMPT TO REMOVE THE STENT. AN ADDITIONAL SUPERA STENT WAS THEN INSERTED AND ADVANCED TO THE ORIGINAL TARGET LESION AND WAS SUCCESSFULLY DEPLOYED WITHOUT ISSUES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11806710 ↗
• InjuryMar 9, 2021Difficult to Remove; Material Separation; Device Dislodged or Dislocated; Difficult to Remove; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A SUPERA PERIPHERAL STENT 5.5X60 WAS INSERTED WITHOUT ISSUES AND DEPLOYED AT THE TARGET LESION. HOWEVER, WHILE REMOVING THE DELIVERY CATHETER, THE TIP BECAME CAUGHT ON THE STENT AND DISLODGED FROM THE DEVICE. IT WAS ALSO NOTED THAT THE STENT HAD BECOME DISLODGED AS WELL. THEREFORE, THE PHYSICIAN DECIDED TO INSERT A SNARE AND REMOVE THE STENT. IT WAS THEN OBSERVED THAT THE TIP OF THE DELIVERY CATHETER HAD MIGRATED AND BECOME EMBEDDED IN THE CALCIUM OF THE AORTA. THE TIP OF THE DELIVERY CATHETER WAS NO LONGER MOBILE; THEREFORE, THE PHYSICIAN DECIDED TO LEAVE IT IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 11445694 ↗
• MalfunctionFeb 26, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. FOLLOWING PRE-DILATATION OF THE 5.5MM VESSEL, A 5.5X60MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED. THE SESS WAS BEING DEPLOYED PER THE INSTRUCTIONS FOR USE AND NO ISSUES WERE NOTED; HOWEVER, THE STENT FULLY RELEASED FROM THE DELIVERY SYSTEM BEFORE THE DEPLOYMENT LOCK WAS ROTATED TO THE UNLOCKED POSITION. THE STENT WAS SUCCESSFULLY DEPLOYED AT THE INTENDED SITE. 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 11385895 ↗
• InjurySep 10, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT SUPERIOR FEMORAL ARTERY (SFA) THAT IS 100% STENOSED. PRE-DILATATION WAS PERFORMED WITH FOUR NON-ABBOTT BALLOON CATHETERS. A 5.0X60MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO A 6.0MM VESSEL WITH RESIDUAL CALCIFICATION, IT WAS NOTED THAT THE PHYSICIAN USED THE PULL-THROUGH GUIDE WIRE TECHNIQUE DUE TO THE HEAVILY CALCIFIED LESION. RESISTANCE WAS FELT DURING REMOVAL OF THE SESS WITH A NON-ABBOTT GUIDE WIRE AND THE TIP SEPARATED. AN ATTEMPT TO REMOVE THE SEPARATED TIP WITH A SNARE AND FORCEPS WAS MADE; HOWEVER, FAILED. A MICROCATHETER WAS INSERTED AND THE SEPARATED TIP REMAINING ON THE GUIDE WIRE WAS PUSHED RETROGRADELY INTO THE SHEATH AND REMOVED SUCCESSFULLY. THE SESS WAS REMOVED UNDER FLUOROSCOPY. IT WAS NOTED THAT THE PHYSICIAN INTENTIONALLY CREATED COMPRESSION AT THE IMPLANT SITE OF THE SUPERA STENT, THEREFORE CAUSING THE STENT TO BE PARTIALLY COMPRESSED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO SIGNIFICANT CLINICALLY DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515399 ↗
• InjuryOct 3, 2019Material Separation; Stretched; Malposition of Device; Material Separation; Stretched; Malposition of Device

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: RETURNED DEVICE ANALYSIS IDENTIFIED A MISSING SEPARATED RATCHET EAR, BUT THE ACCOUNT DID NOT NOTE THIS SEPARATION AT ANY POINT. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR RESISTANCE. IT IS UNKNOWN IF THE SEPARATED RATCHET EAR REMAINS INSIDE THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9152519 ↗
• InjuryOct 5, 2018Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL SUPERFICIAL FEMORAL ARTERY. A 5.5X60MM SUPERA SELF-EXPANDING STENT WAS FULLY DEPLOYED AT THE LESION, WHEN THE DEPLOYMENT LOCK WAS FLIPPED TO LOCK THE DELIVERY SYSTEM, AND DURING REMOVAL THE STENT DRIVER BECAME HOOKED ON PART OF THE PROXIMAL END OF THE STENT. THE STENT THEN GOT ATTACHED TO THE DELIVERY CATHETER AND STRETCHED. ADDITIONALLY THE CATHETER TIP HAD SEPARATED INTO TWO PIECES DURING THE INTERACTION. THE PHYSICIAN PERFORMED A CUT-DOWN SURGERY TO REMOVE THE SEPARATED TIP AND THE SUPERA STENT. ANOTHER SUPERA STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7939937 ↗