SUPERA S-55-080-120-P6 (UDI 08975370026306)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08975370026306), received between Feb 16, 2017 and Mar 2, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2018Detachment Of Device Component

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH NO CALCIFICATION IN THE PROXIMAL COMMON FEMORAL ARTERY. THE SUPERA STENT WAS DEPLOYED AT THE TARGET LESION SUCCESSFULLY. PRIOR TO REMOVAL OF THE DELIVERY SYSTEM, WHEN THE THUMBSLIDE WAS RETRACTED, THE NOSECONE SEPARATED. TWO GUIDE WIRES AND A BALLOON CATHETER WERE ADVANCED TO CAPTURE THE SEPARATED NOSECONE AND RETRIEVE IT SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7310864 ↗
• InjuryJun 20, 2017Detachment Of Device Component

  SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, A MEDSUN REPORT WAS RECEIVED STATING: A SUPERA 5.5X80MM STENT WAS DEPLOYED INTO THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). THREE (3) MORE ZILVER STENTS WERE DEPLOYED AND THEN SMALL SEGMENT OF WIRE VISUALIZED ON ANGIOGRAM. IT WAS THOUGHT THAT THE NOSE CONE OF THE SUPERA THAT HAD BECOME DETACHED FROM THE TIP OF THE STENT. THE STENT APPEARED TO BE DEPLOYED CORRECTLY. A SNARE WIRE WAS DEPLOYED, THE WIRE AND NOSE CONE WAS CAPTURED IN THE SNARE AND PULLED THROUGH THE SHEATH. THE SHEATH WAS CUT AND THE WIRE DRAGGED OUT. THE SHEATH WAS EXCHANGED OVER WIRE FOR NEW 6 ANSEL SHEATH. NO HARM TO PATIENT ASIDE FROM INCREASED RADIATION TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6653423 ↗
• MalfunctionFeb 16, 2017Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A SUPERA STENT WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY TO POPLITEAL ARTERY, MILD-MODERATELY CALCIFIED LESION WITHOUT ISSUE. IT WAS INITIALLY THOUGHT THAT THE THUMBSLIDE WAS FULLY RETRACTED AND LOCKED, SO THE DELIVERY SYSTEM WAS READY FOR REMOVAL. THE GUIDEWIRE WAS REMOVED FROM THE PATIENTS ANATOMY. AFTER REMOVAL, IT WAS THEN NOTED THAT THE SUPERA DELIVERY SYSTEMS TIP HAD SEPARATED. THE TIP WAS HANGING OUT OF THE SHEATH AND WAS LOCATED INSIDE THE GUIDE CATHETER. ALL WAS REMOVED FROM THE PATIENTS ANATOMY AS A SINGLE UNIT. THE SUPERA STENT REMAINED IMPLANTED AT THE INTENDED SITE WITHOUT ANY ISSUE. ONCE THE SUPERA DELIVERY SYSTEM WAS REMOVED, IT WAS THEN OBSERVED THAT THE THUMBSLIDE HAD NOT BEEN FULLY RETRACTED AND LOCKED PRIOR TO SUPERA DELIVERY SYSTEM REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6337901 ↗