SUPERA S-65-060-120-P6 (UDI 08717648226243)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648226243), received between Sep 27, 2019 and Oct 15, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 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.

• InjuryOct 15, 2024Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT HAD A 6.5X60MM SUPERA SELF-EXPANDING STENT IMPLANTED IN THE POPLITEAL ARTERY. THE PATIENT HAD AN ANGIOGRAM PERFORMED ON (B)(6) 2024, AS THE PATIENT WAS EXPERIENCE BACK PAIN. IT WAS NOTED THAT THE SUPERA STENT APPEARED TO BE FRACTURED AND TWISTED. OVER THE COUNTER PAIN MEDICATION WAS GIVEN. THE PATIENT WAS SEEN BY VASCULAR SURGERY AND WILL BE PROCEEDING WITH A BYPASS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20453278 ↗
• InjuryMay 23, 2022Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT SUPERFICIAL FEMORAL ARTERY. THE 6.5 X 60MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND DEPLOYED WITHOUT ISSUE. HOWEVER, AFTER DEPLOYMENT THE PHYSICIAN DID NOT LOCK THE DEVICE PER INSTRUCTIONS FOR USE AND DURING REMOVAL OF THE DELIVERY SYSTEM UNDER FLUOROSCOPY THE TIP SEPARATED. THE SEPARATED TIP WAS REMOVED VIA SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14477596 ↗
• MalfunctionFeb 27, 2020Material Separation; Material Separation

  N/A.

  Patient problems: No Patient Involvement

  MAUDE report 9764312 ↗
• InjurySep 27, 2019Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-TORTUOUS, HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). UNSPECIFIED BALLOON INFLATION WAS PERFORMED, AND A COMMAND .014 GUIDE WIRE WAS USED ALONG WITH A NON-ABBOTT SHEATH WITHOUT ANY ISSUES. BALLOON INFLATION WAS PERFORMED AGAIN AND A 6.5X60MM SUPERA SELF-EXPANDING STENT WAS ADVANCED WITH RESISTANCE DUE TO THE ANATOMY. THE STENT WAS DEPLOYED, BUT WHEN THE DEVICE WAS PULLED BACK, RESISTANCE WITH THE ANATOMY WAS FELT AND THE NOSE CONE SEPARATED FROM THE DELIVERY SYSTEM. BALLOON INFLATION WAS PERFORMED ONCE MORE, AND ANOTHER UNSPECIFIED SUPERA STENT WAS IMPLANTED IN THE LESION WITHOUT ISSUES. A SNARE DEVICE WAS USED TO REMOVE THE NOSE CONE, AND THE FIRST SUPERA STENT REMAINED IMPLANTED IN THE LESION. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9129806 ↗