SUPERA S-55-120-120-P6 (UDI 08975370026320)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08975370026320), received between Oct 21, 2016 and Apr 17, 2019 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2019Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. THE LESION WAS PREPARED WITH A 6 X 150 MM BALLOON. A 5.5 X 120 MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. THE STENT WAS RELEASED UNDER FLUOROSCOPY. THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE TIP BECAME CAUGHT WITH THE STENT. THE STENT REMAINED IN THE TARGET LESION BUT ELONGATED DISTAL FROM THE INITIAL LESION INTO UNPREPPED AREA; ALTHOUGH THERE WAS DISEASE IN THE UNPREPPED AREA. THE STENT BECAME ELONGATED BY 40%. NO POST DILATATION WAS PERFORMED. THE DELIVERY SYSTEM WAS ULTIMATELY REMOVED WITHOUT ISSUE. TWO UNSPECIFIED STENTS WERE DEPLOYED IN THE OSTIAL SFA TO COMPLETE THE PROCEDURE AS PLANNED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524241 ↗
• InjuryMar 8, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED POPLITEAL AND SUPERFICIAL FEMORAL ARTERIES. ATHERECTOMY WAS PERFORMED ON THE CALCIFIED ARTERIES, FOLLOWED BY DILATATION OF THE LESION. AFTER BALLOON DILATATION IT WAS OBSERVED ON ANGIOGRAPHY THAT FURTHER ATHERECTOMY WAS NEEDED AND WAS PERFORMED, WHICH WAS FOLLOWED BY A SHORT DILATATION OF THE AREA. A DISSECTION WAS OBSERVED AT THE DISTAL END OF THE LESION DUE TO THE USE OF THE ATHERECTOMY DEVICE. THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED WITHOUT RESISTANCE FELT AND WAS DEPLOYED SUCCESSFULLY FOR TREATMENT. AT THAT TIME, IT WAS OBSERVED ON ANGIOGRAPHY THAT THE WHITE TIP OF THE CATHETER HAD SEPARATED. THE SUPERA STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, BUT THERE WERE NO ATTEMPTS MADE TO RETRIEVE THE SEPARATED TIP. THE PATIENT UNDERWENT FEMORAL DISTAL BYPASS DURING WHICH THE TIP WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7325330 ↗
• MalfunctionJul 3, 2017Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AFTER LESION PRE-DILATATION WITH A 6.0 MM BALLOON, THE SUPERA STENT WAS ATTEMPTED TO BE DEPLOYED. AFTER ABOUT 40 MM OF THE STENT HAD BEEN DEPLOYED THE HANDLE RATCHET LOST TRACTION AND THE STENT COULD NOT BE DEPLOYED FURTHER. THE DELIVERY SYSTEM AND THE STENT WERE REMOVED FROM THE ANATOMY WITHOUT REPORTED ISSUE. A DIFFERENT SUPERA STENT WAS SUCCESSFULLY USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6685121 ↗
• InjuryMay 30, 2017Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2017, THREE SUPERA STENTS WERE IMPLANTED IN THE PATIENT'S RIGHT UPPER LEG. ON (B)(6) 2017, THE PATIENT EXPERIENCED SEVERE RIGHT LEG PAIN AND A COLD AND BLUE RIGHT LEG. IMAGING WAS PERFORMED AND PER PHYSICIAN, ALL THREE STENTS HAD COLLAPSED. THERE WAS NO REPORTED STENOSIS AND NO REPORTED THROMBOSIS. MEDICATIONS WERE PROVIDED AND, ON (B)(6) 2017, ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED AS TREATMENT, IMPLANTING NEW UNSPECIFIED STENTS WITHIN THAT AREA. THE PATIENT IS FEELING BETTER BUT THERE IS STILL PAIN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: Claudication; Diminished Pulse Pressure; Pain

  MAUDE report 6598917 ↗
• InjuryMay 30, 2017Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2017, THREE SUPERA STENTS WERE IMPLANTED IN THE PATIENT'S RIGHT UPPER LEG. ON (B)(6) 2017, THE PATIENT EXPERIENCED SEVERE RIGHT LEG PAIN AND A COLD AND BLUE RIGHT LEG. IMAGING WAS PERFORMED AND PER PHYSICIAN, ALL THREE STENTS HAD COLLAPSED. THERE WAS NO REPORTED STENOSIS AND NO REPORTED THROMBOSIS. MEDICATIONS WERE PROVIDED AND, ON (B)(6) 2017, ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED AS TREATMENT, IMPLANTING NEW UNSPECIFIED STENTS WITHIN THAT AREA. THE PATIENT IS FEELING BETTER BUT THERE IS STILL PAIN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: Claudication; Diminished Pulse Pressure; Pain

  MAUDE report 6598897 ↗
• InjuryDec 30, 2016Difficult or Delayed Positioning; Difficult To Position; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION. A 5.5X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE TOWARD THE TARGET LESION. AN ATTEMPT WAS MADE TO DEPLOY THE STENT. THE STENT FLOWERED BUT AFTER THAT WAS DIFFICULT TO DEPLOY. ADDITIONALLY, THE STENT COULD NOT BE SEEN. REPORTEDLY A PREVIOUSLY IMPLANTED STENT WAS IN THE WAY. THE PHYSICIAN ATTEMPT TO REMOVE THE DEVICE FROM THE PATIENT ANATOMY AND THE SUPERA STENT BECAME ELONGATED AROUND THE HORN. THE PHYSICIAN PUSHED THE STENT UP INTO THE AORTA AND THE STENT OPENED UP. A SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE STENT FROM THE PATIENT ANATOMY. THE LESION WAS ULTIMATELY TREATED USING AN UNSPECIFIED BALLOON AND A NON-ABBOTT STENT. THERE WAS A DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6215861 ↗
• MalfunctionOct 21, 2016Positioning Failure; Difficult To Position

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ENTIRE LENGTH OF THE LOWER SUPERFICIAL FEMORAL ARTERY THAT WAS HEAVILY CALCIFIED AND TOTALLY OCCLUDED. A SUPERA PERIPHERAL STENT WAS SUCCESSFULLY DEPLOYED. A SECOND SUPERA PERIPHERAL STENT SYSTEM 5.5 X 120 6F 120 CM WAS HALF WAY THROUGH THE LESION WHEN IT WAS NOTICED TO BE GETTING CLOSE TO THE INTRODUCER SHEATH. THE PROXIMAL MARKER WAS OUTSIDE THE SHEATH BY APPROXIMATELY 20MM. THE PHYSICIAN BACKED UP THE SHEATH, THEN CONTINUED TO BE ADVANCE; HOWEVER THE STENT COULD NOT BE DEPLOYED BECAUSE THE SHEATH WAS NOT BACKED UP ENOUGH AND TIP AND RATCHET BECAME TRAPPED IN THE INTRODUCER SHEATH DUE TO A SIGNIFICANT KINK WHICH WAS OBSERVED AFTER HALF OF THE STENT HAD BEEN DEPLOYED. THE STENT WAS VISUALIZED UNDER FLUOROSCOPY WITH AN ESTIMATED 2-3CM UN-DEPLOYED STILL IN THE SHEATH. THE STENT DELIVERY SYSTEM, INCLUDING THE STENT AND SHEATH, WAS REMOVED TOGETHER LEAVING ONLY THE INTERVENTIONAL WIRE IN PLACE. A SECOND ANGIOGRAPHY TO THE VESSEL WAS PERFORMED AND USING A NEW 6F SHEATH, ANOTHER SUPERA STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6047900 ↗