SUPERA S-45-080-120-P6 (UDI 08717648225963)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648225963), received between Jun 4, 2018 and Feb 3, 2026 — classified as 4 injuries, 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE 4.5X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT ISSUES AND SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED; HOWEVER, THE IMPLANTED STENT WAS THEN NOTED TO BE EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250707 ↗
• MalfunctionJan 12, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE POPLITEAL ARTERY WAS PREPARED WITH A NON-ABBOTT 5X4 MM BALLOON DILATATION CATHETER INFLATED TO 14 ATMOSPHERES FOR 120 SECONDS. ATHERECTOMY WAS PERFORMED IN THE STENOTIC AND CALCIFIED VESSEL. AFTER DEPLOYMENT OF THE SUPERA STENT, IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE STENT EMERGED FROM THE SHEATH AND WAS FULLY RELEASED. THERE WAS NO WAIST NOTED ON THE DEPLOYED STENT OR PROXIMAL END OF THE LESION. THE THUMB SLIDE WAS FULLY RETRACTED TO THE START POSITION AND BOTH THE SYSTEM AND DEPLOYMENT LEVERS WERE LOCKED PRIOR TO REMOVAL OF THE SELF-EXPANDING STENT SYSTEM (SESS) UNDER FLUOROSCOPY. THE PHYSICIAN ROTATED THE SYSTEM LOCK AND THE DEPLOYMENT LOCK INTO THE LOCKED POSITION. RESISTANCE WAS MET WHILE REMOVING THE SESS FROM THE ANATOMY. ONCE THE SUPERA WAS PULLED OUT OF THE BODY, THE PHYSICIAN NOTICED A PIECE OF THE SUPERA NOSE CONE WAS LODGED IN THE INTRODUCER SHEATH WHILE FLUOROSCOPY WAS ACTIVE. BECAUSE OF THIS, THEY PULLED THE REST OF THE INTRODUCER SHEATH AND SESS OUT OF THE BODY. ALL OF THE SUPERA STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT ANATOMY, INCLUDING ALL SEGMENTS OF THE SEPARATED SECTION. A NEW INTRODUCER SHEATH WAS INSERTED TO CONTINUE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037097 ↗
• InjuryOct 10, 2025Material Separation; Stretched; Material Separation; Stretched

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, A MEDSUN REPORT WAS RECEIVED STATING THE FOLLOWING: [DESCRIBE THE EVENT OR PROBLEM: DURING THE DEPLOYMENT OF THE STENT TO THE PATIENT'S LEFT POPLITEAL ARTERY, THE NOSE CONE OF THE STENT SHEARED OFF IN THE ARTERY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? LEFT LEG PERIPHERAL ANGIOGRAPHY. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE;] NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23268204 ↗
• InjuryAug 28, 2019Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED PROXIMAL POPLITEAL ARTERY. IT WAS A PERCUTANEOUS INTERVENTION PROCEDURE WITHOUT ATHERECTOMY. THE 4.5X80MM SUPERA PERIPHERAL STENT DELIVERY SYSTEM WAS ADVANCED WITHOUT ANY RESISTANCE NOTED. DURING DEPLOYMENT, IT WAS BELIEVED THAT THE STENT WAS FULLY RELEASED BUT WHEN THE CATHETER WAS PULLED BACK, THE STENT CAME BACK WITH IT. IT WAS CONFIRMED VIA FLUOROSCOPY THAT THE STENT WAS NO LONGER IN PLACE AND IT WAS MOVED TO THE COMMON FEMORAL ARTERY. OUTSIDE OF THE PATIENT IT WAS NOTED THAT THE TIP WAS SEPARATED. A GROIN CUT DOWN WAS DONE TO RETRIEVE THE STENT AND SEPARATED TIP. POST THE GROIN CUT DOWN, THE PATIENT HAD A LIMITED FLOW IN THE ANTERIOR TIBIAL ARTERY. THE PHYSICIAN WAS NOT SURE IF THE LIMITED FLOW WAS DUE TO THE TIME OF GETTING THE STENT AND TIP OUT OR IF PLAQUE HAD CAUSED IT. THE PHYSICIAN THEN OPTED FOR A FULL FEMORAL POPLITEAL BYPASS TO TREAT THE UNSTENTED PROXIMAL POPLITEAL. THE FLOW FROM THE BYPASS RESTORED THE FLOW IN THE ANTERIOR TIBIAL ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO FILING THE INITIAL MEDWATCH REPORT, A USER FACILITY ME

  Patient problems: Ischemia

  MAUDE report 8941383 ↗
• MalfunctionDec 12, 2018Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL POPLITEAL ARTERY. A 4.5 X 80 MM SUPERA PERIPHERAL STENT SYSTEM WAS USED. THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMBSLIDE ADVANCED; HOWEVER, THE STENT WAS ONLY PARTIALLY DEPLOYED. THEREFORE, THE STENT SYSTEM WAS REMOVED THROUGH THE GUIDING CATHETER WITHOUT ISSUES. ANOTHER SUPERA STENT WAS THEN DEPLOYED WITHOUT ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8158410 ↗
• InjuryJun 5, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). DURING DEPLOYMENT OF THE 4.5 X80 MM SUPERA STENT IN THE TARGET LESION, THE STENT GOT CAUGHT ON THE NOSECONE. WHEN THE THUMBSLIDE WAS UNLOCKED, THE STENT DISENGAGED FROM THE NOSECONE. HOWEVER, AS THE SHEATH WAS BEING RETRACTED, THE STENT WAS PULLED FURTHER INTO THE PROXIMAL SFA, INSIDE A PREVIOUSLY IMPLANTED STENT. A BALLOON WAS USED TO POST DILATE THE SUPERA STENT UP AGAINST THE PREVIOUSLY IMPLANTED STENT. ANOTHER SELF-EXPANDING STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7569515 ↗
• InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING PRE-DILATATION WITH A 5.0 BALLOON CATHETER FOR 2-3 MINUTES, A 4.5 SUPERA STENT WAS IMPLANTED IN THE DISTAL POPLITEAL LESION AND FOLLOWING A 5.0 SUPERA STENT WAS IMPLANTED MORE PROXIMAL WITH SOME OVERLAP. BOTH STENTS WERE IMPLANTED WITHOUT ISSUE WITH REPORTED PERFECT RESULTS AND BOTH WERE WELL APPOSED TO THE VESSEL WALL. FOLLOWING, A THROMBUS WAS OBSERVED WITHIN THE STENTS WITH TOTAL OCCLUSION. THE THROMBUS THEN EMBOLIZED DISTALLY AND A 6F CATHETER WAS USED IN ATTEMPT TO RETRIEVE THE THROMBUS. DURING REMOVAL OF THE CATHETER THROUGH THE STENTS, REPORTEDLY THE OPERATOR DID NOT VISUALIZE THE SHEATH DURING REMOVAL AND THE SHEATH CAUGHT THE 5.0 SUPERA STENT AND ELONGATED THE 5.0 STENT. THE STENTS REMAINED WELL APPOSED TO THE VESSEL WALL. ON (B)(6) 2018, A BYPASS WAS PERFORMED, LEAVING THE SUPERA STENTS WITHIN THE PATIENTS ANATOMY. THE PATIENT IS IN STABLE CONDITION WITHOUT FURTHER ISSUES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Thrombosis

  MAUDE report 7565696 ↗