SUPERA S-55-060-120-P6 (UDI 08975370026290)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08975370026290), received between Jan 16, 2017 and Mar 19, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 5.5X60 MM SUPERA STENT WAS IMPLANTED IN THE RIGHT POPLITEAL TO SUPERFICIAL FEMORAL ARTERY. THE FOLLOWING YEAR, ON (B)(6) 2018 THE PATIENT HAD LEG PAIN AND WAS FOUND WITH IN-STENT RESTENOSIS OF THE SUPERA STENT. THE LESION WAS TREATED WITH LASER ATHERECTOMY AND BALLOON DILATATION. THE CONDITION RESOLVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Pain; Stenosis

  MAUDE report 7349483 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2018 DURING WHICH A 5.5 X 60 MM SUPERA STENT WAS IMPLANTED TO OPEN THE RIGHT POPLITEAL ARTERY. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR AN OCCLUSION OF THE LEFT POPLITEAL ARTERY, AND IN-STENT RESTENOSIS OF THE RIGHT POPLITEAL ARTERY, WHERE THE 5.5 X 60 MM SUPERA STENT WAS IMPLANTED. REVASCULARIZATION WAS DONE TO TREAT THE OCCLUSION IN THE LEFT POPLITEAL ARTERY WHICH INCLUDED PERFORMING LASER THERAPY, DILATING THE LESION WITH AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC) AND IMPLANTING THREE UNSPECIFIED SUPERA STENTS. REVASCULARIZATION WAS ALSO DONE TO TREAT THE IN-STENT RESTENOSIS OF THE RIGHT POPLITEAL ARTERY WHICH INCLUDED PERFORMING LASER THERAPY AND DILATING THE LESION WITH AN UNSPECIFIED BDC. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 7339762 ↗
• MalfunctionMar 5, 2018Positioning Failure

  IT WAS REPORTED THE SUPERA STENT WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING DEPLOYMENT OF THE STENT, THE PHYSICIAN DID NOT REALIZE THE STENT WAS BEING DEPLOYED INSIDE THE SHEATH AND THE DEPLOYMENT LOCK WAS NOT UNLOCKED; THEREFORE, WHEN THE DEVICE WAS WITHDRAWN, THE STENT WAS PULLED INTO THE SHEATH. THE STENT WAS ENCAPSULATED INTO THE SHEATH AND REMOVED WITH THE DEVICE WITHOUT ANY CONSEQUENCES. THE PROCEDURE WAS ABORTED, THE LESION WAS TREATED WITH ANGIOPLASTY ONLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7313849 ↗
• InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 WEEKS POST IMPLANTATION OF 2 SUPERA STENTS IN THE SUPERFICIAL FEMORAL (SFA) ARTERY, DURING A FOLLOW-UP ULTRASOUND VISIT, IN-STENT RESTENOSIS WAS NOTED AND TREATED WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6254852 ↗
• InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 WEEKS POST IMPLANTATION OF 2 SUPERA STENTS IN THE SUPERFICIAL FEMORAL (SFA) ARTERY, DURING A FOLLOW-UP ULTRASOUND VISIT, IN-STENT RESTENOSIS WAS NOTED AND TREATED WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6254851 ↗