SUPERA S-45-040-120-P6 (UDI 08717648225925)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648225925), received between Nov 2, 2020 and Jul 12, 2023 — classified as 1 injury, 4 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 16, 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.

• MalfunctionJul 12, 2023Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE POPLITEAL ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 60% STENOSIS. THE VESSEL DIAMETER WAS 4 MM, ATHERECTOMY WAS NOT PERFORMED AND PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT 5X100 MM BALLOON AT 8 ATMOSPHERES FOR 2 MINUTES. THE 4.5X40 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) FAILED TO DEPLOY THE STENT AND THE SHAFT TIP OF THE DEVICE DETACHED BUT REMAINED WITH THE DELIVERY SYSTEM. THE DELIVERY SYSTEM AND SEPARATED PORTION WERE REMOVED FROM THE PATIENT WITHOUT ANY COMPLICATIONS AND THERE WERE NO ADVERSE PATIENT EFFECTS. A 4.5X80 MM SUPERA STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309490 ↗
• MalfunctionMay 18, 2023Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. ONE FIRST SUPERA STENT WAS SUCCESSFULLY IMPLANTED . ANOTHER 4.50X40MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS DEPLOYED. DURING REMOVAL OF THE SESS, THE SUPERA STENT MIGRATED. A PORTION OF THE STENT REMAINED IN THE TARGET LESION, WHILE A PORTION OF THE STENT WAS IN HEALTHY TISSUE. ANOTHER NON-ABBOTT STENT WAS IMPLANTED TO TREAT THE REST OF THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955427 ↗
• MalfunctionFeb 27, 2023Product Quality Problem; Material Separation; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL AND DISTAL FEMORAL ARTERY (SFA) VIA A DIRECT STICK TO THE POPLITEAL THROUGH A BYPASS GRAFT. THE VESSEL DIAMETER WAS 4-4.5MM, AND THE ATHERECTOMY WAS NOT USED. DURING PREPARATION OF A 4.5X40MM SUPERA SELF EXPANDING STENT (SSES) THE NOSECONE APPEARANCE DID NOT LIKE HOW IT LOOKED THEREFORE WAS NOT USED IN THE PATIENT. ANOTHER 4.5X60MM SUPERA SSES WAS PREPARED, AND THE VESSEL WAS PREPARED WITH A BALLOON DILATATION. THE STENT WAS DEPLOYED; AND DURING REMOVAL UNDER FLUOROSCOPY, THE RED LEVERS WERE NOT LOCKED BEFORE THE CATHETER WAS BEING PULLED OUT, THE NOSECONE GOT STUCK ON THE STENT STRUT AND THEN DETACHED. THE NOSECONE WAS UNABLE TO BE REMOVED FROM THE LOCATION. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. THE NOSECONE REMAINS IN THE PERONEAL ARTERY; HOWEVER, THE ARTERY WAS CONFIRMED TO BE PATENT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. RETURNED DEVICE ANALYSIS OF THE 4.5X40 SUPERA SESS IDENTIFIED A SEPARATED TIP WHICH WAS NOT RETURNED. THE ACCOUNT STATED IT WAS LIKELY DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444222 ↗
• MalfunctionAug 5, 2022Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. THE 4.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). FOLLOWING PRE-DILATATION WITH AN UNSPECIFIED 5MM BALLOON AT NOMINAL PRESSURE, THE SESS WAS ADVANCED. THE SESS WAS BEING DEPLOYED PER THE IFU; HOWEVER, IT ONLY DEPLOYED ABOUT 10MM AND THEN THE THUMBSLIDE STOPPED WORKING AND IT COULD NOT BE FURTHER DEPLOYED. THE SESS WAS LOCKED AND THE SESS AND STENT WERE REMOVED TOGETHER WITHOUT RESISTANCE. THE SESS AND STENT WERE REMOVED WITHOUT FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 4.5X16MM SUPERA STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176167 ↗
• InjuryNov 2, 2020Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATATION WAS PERFORMED WITH A 5MM BALLOON. A 4.5X40MM SUPERA STENT WAS ADVANCED TO THE LESION AND ONCE DEPLOYED A CONTROL INJECTION WAS MADE, WHEN IT WAS NOTED THAT THE STENT BEGAN MOVING DOWN AND STOPPED MOVING IN THE MID/PROXIMAL PORTION OF THE POPLITEAL ARTERY (NON-TARGET LESION). A SECOND SUPERA STENT WAS IMPLANTED IN THE SFA WHERE IT WAS LONG ENOUGH THAT IT OVERLAPPED WITH THE MIGRATED STENT IN THE POPLITEAL, HOWEVER, IT WAS CONFIRMED THAT THERE WAS NOTHING EXTERNALLY DONE TO TREAT THE MIGRATED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10775098 ↗