Supera™ S-70-100-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648350627), received between Apr 3, 2024 and Jul 1, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE SUPERFICIAL FEMORAL ARTERY. THE VESSEL DIAMETER WAS 7.0MM AND WAS PREDILATED WITH A 7.0MM BALLOON DILATATION CATHETER. A 6FR X 45CM SHEATH WAS USED DURING THE PROCEDURE. THE 7.0X100MM SUPERA STENT WAS DEPLOYED AT THE TARGET VESSEL, BUT THE SUPERA TIP GOT CAUGHT ON THE STENT AND SHEARED OFF. THE THUMB SLIDE WAS NOT FULLY RETRACTED TO THE START POSITION AND BOTH THE SYSTEM WITH DEPLOYMENT LEVERS LOCKED PRIOR TO REMOVAL. THE SEPARATED TIP WAS SNARED. THERE WAS NO DAMAGE TO THE IMPLANTED SUPERA STENT IN THE TARGET VESSEL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643597 ↗
• MalfunctionApr 3, 2024Material Separation; Stretched; Difficult or Delayed Activation; Deformation Due to Compressive Stress; Material Separation; Stretched; Difficult or Delayed Activation; Deformation Due to Compressive Stress

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION OF THE POPLITEAL AND DISTAL SUPERFICIAL FEMORAL ARTERY. THE 7.0X100MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION. IT WAS THOUGHT THE STENT HAD FULLY DEPLOYED HOWEVER DURING REMOVAL IT WAS NOTED THE STENT WAS STILL PARTIALLY IN THE SHEATH AND HAD ELONGATED. DURING RETRACTION THE STENT WAS ABLE TO BE FULLY DEPLOYED; HOWEVER SINCE IT ELONGATED IT WAS DEPLOYED IN THE TARGET LESION AND PARTIALLY IN HEALTHY TISSUE. AFTER THE SES WAS REMOVED FROM THE PATIENT IT WAS NOTED THE NOSE CONE WAS MISSING AND THE SHEATH WAS KINKED. ANGIOGRAM WAS PERFORMED HOWEVER THE MISSING NOSE CONE WAS NOT FOUND IN THE PATIENT. AS A PRECAUTION, DOPPLER WAS PERFORMED TO ENSURE THE LEG HAD PROPER FLOW, AND THE FLOW SOUNDED GREAT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031397 ↗