SUPERA S-65-100-120-P6 (UDI 08717648226281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648226281), received between May 25, 2018 and Jun 3, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2022Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) THAT WAS MILDLY CALCIFIED. THE SUPERA STENT SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE AND THE STENT WAS DEPLOYED; HOWEVER, WHILE REMOVING THE DELIVERY SYSTEM, THE STENT WAS REMOVED AS WELL. IT WAS SUSPECTED THAT FLUOROSCOPY WAS NOT USED WHEN REMOVING THE DELIVERY SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS ABORTED AS THE ACCESS SITE HAD BEEN LOST. THE PATIENT WILL BE MONITORED UNTIL ANOTHER PROCEDURE IS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597380 ↗
• InjuryNov 13, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). AFTER INTRODUCING A 6.5X100MM SUPERA SELF-EXPANDING STENT DELIVERY SYSTEM INTO THE ANATOMY, THE TIP OF THE STENT BROKE OFF WHILE ATTEMPTING TO DEPLOY. THE NOSE CONE GOT CAUGHT AT THE END OF THE STENT, HOWEVER THE STENT WAS ABLE TO BE DEPLOYED SUCCESSFULLY. THE PHYSICIAN DID NOT HAVE A SNARE DEVICE TO REMOVE THE TIP, SO A SECOND STENT WAS DEPLOYED OVER THE TIP WITH A GOOD RESULT. THE TIP STILL REMAINS IN THE ANATOMY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9315282 ↗
• MalfunctionMar 14, 2019Difficult to Remove; Stretched; Activation Failure; Difficult to Remove; Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. AN UNSPECIFIED SUPERA STENT WAS DEPLOYED WITHOUT ISSUE AT THE LESION. THEN A SECOND 6.5X100MM SUPERA STENT WAS PLANNED FOR IMPLANT. THE PHYSICIAN PUSHED THE THUMBWHEEL FULLY FORWARD AND HAD ASSUMED THAT THE SUPERA STENT HAD DEPLOYED FULLY AT THE LESION. HOWEVER, THE STENT ONLY PARTIALLY DEPLOYED, STILL PART OF IT INSIDE THE CATHETER. THE PHYSICIAN THEN PULLED THE CATHETER FOR REMOVAL WHEN RESISTANCE WAS NOTED WITH THE INTRODUCER SHEATH. THE PHYSICIAN THEN REALIZED THE SUPERA STENT HAD ONLY BEEN PARTIALLY DEPLOYED. THE SHEATH WITH THE STENT WAS REMOVED ALTOGETHER AS A SINGLE UNIT. ONCE OUTSIDE OF THE ANATOMY, IT WAS NOTED THAT THE SUPERA STENT HAD STRETCHED. A NEW SHEATH AND NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422583 ↗
• MalfunctionMay 25, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 THE SUPERA STENT WAS SUCCESSFULLY IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS NOTED ON (B)(6) 2018 THAT THE IMPLANTED STENT HAD EXPIRED ON (B)(6) 2018. THERE WERE NO ADVERSE PATIENT EFFECTS FROM USE OF THE EXPIRED DEVICE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546536 ↗