SUPERA S-45-080-120-P6 (UDI 08975370026252)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08975370026252), received between Sep 23, 2016 and Mar 13, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 13, 2018Detachment Of Device Component; Positioning Failure; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. FOLLOWING PRE-DILATATION, AN ATTEMPT TO IMPLANT A 4.5X80MM SUPERA PERIPHERAL STENT IN A 2.5MM SIZE VESSEL WAS MADE; HOWEVER, THE STENT ELONGATED OVER 10% FROM OUTSIDE THE PROCEDURE SHEATH. THE THUMB SLIDE WAS RETRACTED AND THE TIP SEPARATED WHEN THE STENT SYSTEM WAS BEING REMOVED, BUT IT REMAINED IN THE PROCEDURE SHEATH. THE SYSTEM WAS REMOVED AS A UNIT UNDER FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH MANUAL PRESSURE. 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 7334415 ↗
• MalfunctionFeb 23, 2017Detachment Of Device Component; Positioning Failure; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A MILDLY TO MODERATELY CALCIFIED LESION IN THE MILDLY TORTUOUS, DIFFUSELY DISEASED 4.5MM PROXIMAL POPLITEAL TO SUPERFICIAL FEMORAL ARTERY REGION, AFTER PERFORMING PRE-DILATATION VIA INFLATION TO NOMINAL PRESSURE FOR ONE MINUTE WITH AN UNSPECIFIED 45.0X120MM BALLOON, A 4.5MM X 80MM X 120CM 6FR SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS PREPARED PER THE INSTRUCTIONS FOR USE AND WAS ADVANCED VIA RIGHT FEMORAL ARTERY ACCESS PAST THE GUIDING CATHETER AND TO THE TARGET LESION WITHOUT DIFFICULTY. THE THUMBSLIDE WAS RETRACTED INTO THE PROXIMAL-MOST POSITION WITHOUT DIFFICULTY, THE DEPLOYMENT LOCK WAS ROTATED TO THE LEFT WITHOUT ISSUE, THEN THE THUMBSLIDE WAS ADVANCED DISTALLY, BUT, REPORTEDLY, THE FINAL DISTAL THUMB PUSH WAS INADVERTENTLY NOT PERFORMED ON THE THUMBSLIDE, RESULTING IN INCOMPLETE DEPLOYMENT OF THE SUPERA STENT; THE PROXIMAL END OF THE STENT WAS NOT COMPLETELY RELEASED FROM THE SHEATH. THE PARTIALLY EXPANDED STENT AND ITS DELIVERY SYSTEM WERE REPORTEDLY ABLE TO BE RETRACTED FROM THE ANATOMY AND THROUGH THE SHEATH WITHOUT DIFFICULTY AND WITHOUT DAMAGE TO THE VESSEL. ANOTHER UNSPECIFIED DEVICE WAS SUCCESSFULLY USE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6354400 ↗
• InjuryFeb 9, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 THE 4.5 X 80 SUPERA STENT WAS IMPLANTED IN THE PERIPHERAL ARTERY. ON (B)(6) 2017 BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT IN-STENT RESTENOSIS OF THE SUPERA. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6315487 ↗
• 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 5975417 ↗