SUPERA S-45-100-120-P6 (UDI 08975370026269)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08975370026269), received between Aug 24, 2016 and May 31, 2017 — 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.

• InjuryMay 31, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, FOLLOWING PREDILATATION, A SUPERA STENT WAS IMPLANTED IN THE PROXIMAL POPLITEAL, HEAVILY CALCIFIED LESION WITHOUT ISSUE. ON (B)(6) 2017, DURING A FOLLOW-UP VISIT, THE PATIENT PRESENTED WITH POOR CIRCULATION. IMAGING WAS PERFORMED AND STENOSIS WAS NOTED IN THE SUPERA STENT. NO TREATMENT HAS YET BEEN REPORTED AND THERE WAS NO HOSPITALIZATION. PERCUTANEOUS TRANSLUMINAL INTERVENTION IS A POSSIBLE TREATMENT IN THE FUTURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: Diminished Pulse Pressure; Stenosis

  MAUDE report 6603141 ↗
• MalfunctionNov 14, 2016Detachment Of Device Component; Positioning Failure; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LONG SEGMENT CHRONIC TOTAL OCCLUSION LOCATED IN THE SEVERELY CALCIFIED/FIBROSED SUPERFICIAL FEMORAL ARTERY. THE VESSEL DIAMETER WAS 5 MM AND WAS PRE-DILATED USING A 5 MM BALLOON AT HIGH PRESSURE. THE 4.5 X 100 MM SUPERA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, AFTER DEPLOYMENT OF THE STENT FOR ABOUT 5 MM IT STOPPED DEPLOYING DUE TO THE DEPLOYMENT MECHANISM JAMMING. RETRACTION OF THE STENT DELIVERY SYSTEM WAS PERFORMED USING ANGIOGRAPHY. DURING RETRACTION OF THE STENT DELIVERY SYSTEM THE TIP OF THE CATHETER SEPARATED; HOWEVER, THE SHEATH WITH THE STENT INSIDE AND TIP WERE ABLE TO BE REMOVED LEAVING NOTHING IN THE PATIENT. ANOTHER STENT WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6100989 ↗
• 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 5975418 ↗
• InjuryAug 24, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE WAS ON (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 5902332 ↗