SUPERA S-45-120-120-P6 (UDI 08975370026276)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08975370026276), received between Aug 16, 2016 and Apr 30, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2018Difficult to Remove; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A NON-ABBOTT EMBOLIC PROTECTION FILTER AND GUIDE WIRE WERE ADVANCED TO THE LESION AND THE 4.5X120MM SUPERA SELF EXPANDING STENT SYSTEM WAS ADVANCED OVER THE WIRE. RESISTANCE WAS MET ADVANCING THE SUPERA DEVICE DUE TO THE ANATOMY AND THE GUIDE WIRE KEPT BACKING OUT AND MOVING. THERE WAS NO RESISTANCE ADVANCING THE SUPERA OVER THE GUIDE WIRE. THE SUPERA WAS ADVANCED TO THE LESION AND DURING DEPLOYMENT, THE GUIDE WIRE MOVED BACK AND THE FILTER WAS PULLED INTO THE NOSECONE OF THE SUPERA AND BECAME STUCK. THE STENT WAS ABLE TO BE SUCCESSFULLY DEPLOYED. THE SUPERA WAS REMOVED WITH THE FILTER STILL IN THE NOSECONE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473998 ↗
• InjuryNov 2, 2016Detachment Of Device Component; Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method; Material Deformation

  SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, A USER FACILITY MEDWATCH REPORT WAS RECEIVED ON (B)(6) 2016 AND STATES: RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WAS HEAVILY CALCIFIED. CARDIOLOGIST STENTED THE RIGHT SFA WITH A SUPERA STENT SYSTEM. AFTER THE STENT WAS DEPLOYED, THE DELIVERY DEVICE TIP CAME LOOSE AND WAS WEDGED BETWEEN THE LESION INSIDE THE STENT WHILE REMOVING THE DEVICE. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE TIP WITH VARIOUS GUIDE WIRES, AND SNARE AND BALLOONS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ABDOMINAL AORTOGRAPHY AND SELECTIVE RIGHT ILIAC ANGIOGRAPHY AND RUNOFF. SUCCESSFUL ORBITAL ATHERECTOMY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. RIGHT SUPERFICIAL FEMORAL ARTERY SELF-EXPANDING SUPERA STENT, 4.5X120. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6074350 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, 5 SUPERA STENTS WERE IMPLANTED IN THE PROXIMAL POPLITEAL TO THE SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT REPORTED ISSUE. THE PATIENT WAS PROVIDED ASPIRIN AND PLAVIX. ON (B)(6) 2016, THE PATIENT PRESENTED TO THE HOSPITAL. THE SAME LEG CONTAINING THE IMPLANTED SUPERA STENTS WAS COLD AND PAINFUL. PER ANGIOGRAM, A BLOOD CLOT WAS NOTED IN ALL 5 STENTS, A TOTAL OCCLUSION. THE PATIENT WAS HOSPITALIZED AND BALLOON ANGIOPLASTY WAS PERFORMED USING A DRUG ELUTING BALLOON. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS PROVIDED OVERNIGHT. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Claudication; Thrombosis

  MAUDE report 5975399 ↗
• InjuryAug 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 THREE SUPERA STENTS (4.5 X 120 MM (X2), 4.5 X 60 MM) WERE IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT HAD CALF PAIN AND IN-STENT RESTENOSIS IN ALL THREE STENTS ON (B)(6) 2016. LASER ATHERECTOMY AND BALLOON ANGIOPLASTY WERE PERFORMED. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Stenosis

  MAUDE report 5880642 ↗