SUPERA S-45-100-120-P6 (UDI 08717648225987)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648225987), received between Aug 28, 2019 and Nov 19, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 4.5X100MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED WITH DIFFICULTY AS A DECENT AMOUNT FORCE WAS USE TO KEEP THE SUPERA COMPRESSED DURING DEPLOYMENT. WHEN ATTEMPTING TO REMOVE THE DELIVERY SYSTEM UNDER FLUOROSCOPY THE TIP OF THE DELIVERY SYSTEM SEPARATED. A NON-ABBOTT STENT WAS USED TO EMBED THE TIP IN THE SFA. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23599474 ↗
• MalfunctionJul 26, 2023Difficult or Delayed Activation; Mechanical Jam; Activation Failure; Difficult or Delayed Activation; Mechanical Jam; Activation Failure

  SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE ISSUE WAS RESISTANCE WITH THE THUMBSLIDE. THE STENT WAS IMPLANTED IN THE PATIENT. NO REPLACEMENT DEVICE WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17400485 ↗
• MalfunctionJul 10, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). POST-STENT IMPLANTATION OF 2 STENTS IN THE SFA, THE 4.5X100MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED PROXIMALLY TO THE IMPLANTED STENTS AND THE STENT WAS DEPLOYED; HOWEVER, THE STENT DEPLOYED PARTIALLY IN THE VESSEL AND PARTIALLY IN THE SHEATH. WHEN THE SESS WAS REMOVED, THE STENT CAME OUT WITH IT. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17292430 ↗
• MalfunctionJan 2, 2023Break; Difficult to Remove; Material Separation; Activation Failure; Break; Difficult to Remove; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL SUPERFICIAL FEMORAL TO POPLITEAL ARTERIES. THE LESION WAS BEING PRE-DILATATED WITH A 3.0 UNSPECIFIED BALLOON WHICH CAUSED A DISSECTION. THEN IT WAS DECIDED TO USE A SUPERA STENT TO TREAT THE DISSECTION. THE SUPERA STENT WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND WAS THOUGHT TO HAVE BEEN FULLY DEPLOYED. THERE WAS NO ISSUE WITH THE DEPLOYMENT MECHANISM. DURING PULLBACK BACK INTO THE INTRODUCER SHEATH, RESISTANCE WAS MET AND IT WAS NOTED THAT THE NOSE CONE HAD FRACTURED (REMAINING IN ONE PIECE) INSIDE THE SHEATH. THEN IT WAS ALSO NOTED THAT THE SUPERA STENT HAD NOT DEPLOYED AT THE LESION LOCATION BUT RATHER ONLY PARTIALLY DEPLOYED STILL REMAINING ON THE DELIVERY SYSTEM. IT WAS DECIDED TO PULL OUT ALL DEVICES ALTOGETHER. NOTHING WAS LEFT IN THE PATIENT ANATOMY. DISSECTION WAS TREATED VIA BALLOONING WITH NO ISSUES AND CONTINUES TO BE MONITORED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16081961 ↗
• MalfunctionFeb 10, 2021Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, NON-TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS DONE WITH A 5.0 BALLOON. ATHERECTOMY WAS NOT USED. DURING DEPLOYMENT OF THE 4.5X100MM SUPERA STENT, THE STENT WAS DEPLOYED TOO CLOSE TO THE 6F SHEATH (55CM) AND THE TIP SEPARATED. THE TIP REMAINED ON THE WIRE AND WAS REMOVED WITH THE WIRE AND SHEATH AS A SINGLE UNIT. OUTSIDE OF THE PATIENT, THE 6F SHEATH WAS CUT TO CONFIRM THE TIP WAS REMOVED. THE STENT REMAINS IMPLANTED IN THE TARGET LESION. PER THE PHYSICIAN, THERE MAY HAVE BEEN A LITTLE RESISTANCE WHEN THE SYSTEM LOCK WAS ROTATED AND THE DEPLOYMENT LOCK WAS LOCKED IN POSITION (IN LINE WITH THE THUMB SLIDE). 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 11308147 ↗
• InjuryDec 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTIONAL PROCEDURE TO TREAT THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE 4.5X100 MM SUPERA STENT WAS IMPLANTED AND THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. WHEN A POST-DILATATION BALLOON WAS UNABLE TO ADVANCE DOWN A GUIDE WIRE, A FLUOROSCOPY IMAGE SHOWED THAT THE TIP OF THE SUPERA DELIVERY SYSTEM HAD DETACHED AND WAS IN THE DISTAL SFA. THE SEPARATED TIP WAS REMOVED WITH A SNARE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10960640 ↗
• MalfunctionAug 28, 2019Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL - POPLITEAL ARTERY. A 4.5 X 100 MM SUPERA PERIPHERAL STENT SYSTEM WAS USED. IT WAS THOUGHT THAT THE STENT FULLY DEPLOYED; HOWEVER, THE STENT WAS UNINTENTIONALLY REMOVED DURING REMOVAL OF THE DEVICE. THE STENT WAS PARTIALLY DEPLOYED AND THERE WERE ISSUES WITH THE RATCHET MECHANISM. 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 8940174 ↗