SUPERA S-45-060-120-P6 (UDI 08975370026245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08975370026245), received between Aug 16, 2016 and Dec 17, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Advance” (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.

• InjuryDec 17, 2018Failure to Advance

  A SUPERA 4.5X60MM SELF EXPANDING STENT WAS ADVANCED AND DEPLOYED IN THE P1/P2 POPLITEAL SEGMENT. WHEN TRYING TO RESHEATH THE DELIVERY CATHETER, THE DELIVERY COMPONENT BECAME ENTRAPPED IN THE P2 SEGMENT OF THE STENT AND FRACTURED. A 5.0MM CORONARY BALLOON WAS ATTEMPTED TO ADVANCE OVER THE 0.014 MIRACLE BROS WIRE TO EXPAND THE STENT AROUND THE RETAINED FRAGMENT. THIS WAS UNSUCCESSFUL. NEXT A 0.014 FIELDER XT WAS ATTEMPTED TO WIRE AROUND THE RETAINED FRAGMENT TO GET A BALLOON NEXT TO THE DELIVERY COMPONENT, WHICH WAS UNSUCCESSFUL. FINALLY, AND AMPLATZ 9.0MM GOOSENECK SNARE WAS ADVANCED AND ATTEMPTED TO ENTRAP THE DEVICE - WHICH WAS UNSUCCESSFUL. AT THIS POINT, THE DECISION WAS MADE TO ABORT THE PROCEDURE AND CALL VASCULAR SURGERY FOR CONSULTATION FOR FRAGMENT REMOVAL. THE WIRES WERE REMOVED. THE SHEATH WAS EXCHANGED FOR STANDARD 6FX12CM SHEATH WHICH WAS SUTURED INTO PLACE. THE STENT SYSTEM WAS REMOVED TWO DAYS LATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8168775 ↗
• 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 5975416 ↗
• InjuryAug 24, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE WAS (B)(6) 2016 WHERE TWO SUPERA STENTS (4.5 X 60 MM AND 4.5 X 100 MM) WERE IMPLANTED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2016 THE PATIENT WAS RETURNED WITH IN-STENT RESTENOSIS AND THE PATIENT WAS TAKEN FOR BYPASS SURGERY. THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 5902329 ↗
• 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 5880641 ↗