SUPERA S-55-150-120-P6 (UDI 08717648226168)Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 08717648226168), received between May 4, 2018 and Jun 26, 2026 — classified as 41 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (37 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 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Migration

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY. THE 5.50X150MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT, THE STENT SLIDE BACK TO THE COMMON FEMORAL ARTERY AND DID NOT MAINTAIN ITS STARTING POSITION IN THE PROXIMAL POPLITEAL ARTERY. A SECOND SUPERA STENT WAS IMPLANTED TO COVER THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25635075 ↗
• MalfunctionJun 16, 2026Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY LESION. THE 5.5X150 MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE TARGET LESION AND FULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE SES, ELONGATION OCCURRED AND THE STENT WAS REMOVED. THIS ALSO OCCURRED WITH THE SECOND 5.5X150 MM SUPERA SES AND THE THIRD 5.5X120 MM SUPERA SES. A FOURTH 5.5X150 MM SUPERA SES AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524239 ↗
• MalfunctionJun 16, 2026Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY LESION. THE 5.5X150 MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE TARGET LESION AND FULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE SES, ELONGATION OCCURRED AND THE STENT WAS REMOVED. THIS ALSO OCCURRED WITH THE SECOND 5.5X150 MM SUPERA SES AND THE THIRD 5.5X120 MM SUPERA SES. A FOURTH 5.5X150 MM SUPERA SES AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524237 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, ONE 6.0X100 MM ABSOLUTE PRO STENT AND ONE 5.5X150 MM SUPERA STENT WERE IMPLANTED IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2025, COMPUTED TOMOGRAPHY ANGIOGRAPHY SUGGESTED MULTI VESSEL STENOSIS AND OCCLUSION IN THE LOWER LIMB ARTERY. THE DEGREE OF IN-STENT RESTENOSIS WAS 60% IN BOTH THE SUPERA AND ABSOLUTE PRO STENTS. ON (B)(6) 2025, BALLOON ANGIOPLASTY OF THE RIGHT POSTERIOR TIBIAL ARTERY AND POPLITEAL ARTERY WAS PERFORMED. AFTERWARDS, THE PATIENT UNDERWENT HEMODIALYSIS. ON (B)(6) 2025, THE PATIENT UNDERWENT A RIGHT SECOND TOE AMPUTATION SECONDARY TO DIABETIC FOOT GANGRENE. AFTER THE INTERVENTION, SYMPTOMATIC TREATMENT SUCH AS ANTI-INFECTION, PAIN RELIEF AND REHYDRATION WAS GIVEN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Impaired Healing; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 25364486 ↗
• InjuryMay 7, 2026Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% RESTENOSIS. A 5.5X150 MM SUPERA SELF-EXPANDING STENT WAS IMPLANTED WITH THE STENT ENDING IN THE DISTAL END OF A PREVIOUSLY PLACED STENT IN THE PROXIMAL SFA. HOWEVER, AFTER REMOVAL, THE PHYSICIAN NOTICED THE TIP OF THE SUPERA STENT SYSTEM WAS DETACHED FROM THE CATHETER. FLUOROSCOPY CONFIRMED THE SEPARATED TIP WAS ATTACHED TO THE PROXIMAL STENT. THE PHYSICIAN DECIDED TO ADVANCE THE 0.014 VIPERWIRE DOWN THE RIGHT SIDED ARTERY DISTALLY. ONCE PLACED HE ADVANCED A NON-ABBOTT 3.0X20 MM BALLOON CATHETER PAST THE SUPERA STENT TIP. THE BALLOON WAS INFLATED AND RETRACTED THE TIP; HOWEVER, THE BALLOON WOULD SLIP BACK FROM THE TIP. THE BALLOON WAS DEFLATED AND THEN ADVANCED PAST THE SUPERA STENT TIP AND RETRACTED THE STENT TIP A LITTLE MORE BEFORE THE BALLOON SLIPPED BACK. THE BALLOON WAS DEFLATED AND REMOVED. ANOTHER NON-ABBOTT BALLOON CATHETER WAS ADVANCED PAST THE SUPERA STENT TIP, THE BALLOON INFLATED AND RETRACTED BACK AND PROCEEDED TO RETRACT THE TIP WITH THE BALLOON INTO THE 6FR. X 45CM SHEATH. ONCE THE TIP OF THE SUPERA STENT WAS IN THE SHEATH THE BALLOON WAS DEFLATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116385 ↗
• MalfunctionApr 29, 2026Stretched; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.50X150MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. WHEN DEPLOYING THE STENT, IT ELONGATED PARTIALLY INTO HEALTHY TISSUE. THE SES WAS REMOVED AND THE PROCEDURE COMPLETED USING A NEW DEVICE. 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 25033031 ↗
• MalfunctionMar 2, 2026Stretched; Difficult to Advance; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 50% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 5.5X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT WAS NOTED TO BECOME ELONGATED. THEREFORE, THE SESS WAS REMOVED FROM THE PATIENT. ADDITIONAL PRE-DILATION WAS PERFORMED, AND AN UNSPECIFIED STENT WAS DEPLOYED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484364 ↗
• MalfunctionJan 8, 2026Stretched; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A TOTALLY OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). A .014 HT COMMAND GUIDEWIRE WAS USED WITHOUT ISSUES. THE 5.5X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS UNLOCKED PER THE PHYSICIAN AND DEPLOYED BUT THE STENT GOT PULLED WITH THE DELIVERY SYSTEM UPON REMOVAL UNDER FLUOROSCOPY. THE DELIVERY SYSTEM WAS UNLOCKED AGAIN AND THEN WAS DEPLOYED WITH THE MAJORITY OF THE STENT IN THE TARGET LESION BUT OCCUPIED SOME HEALTHY TISSUE PROXIMALLY. THE IMPLANTED STENT STRETCHED BUT ELONGATED LESS THAN 10% OF THE EXPECTED LENGTH. A BALLOON WAS USED FOR POST DILATATION PER STANDARD PROCEDURE. 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 24014125 ↗
• MalfunctionJan 5, 2026Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA) WITH HEAVY CALCIFICATION. FOR PRE-DILATION, 5MM JADE BALLOON WAS USED. THEN, 5.5X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, AFTER DEPLOYING ONE-THIRD OF THE STENT, THE STENT APPEARED TO HAVE SIGNIFICANTLY ELONGATED (MORE THAN 10%). THEREFORE, THE SESS WAS REMOVED WITHOUT ISSUE. A 5X120MM SUPERA STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967594 ↗
• MalfunctionJan 2, 2026Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RE-STENOSED, HEAVILY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS 100% STENOSED. ENDOVASCULAR THROMBECTOMY WAS PERFORMED FOR THE CHRONIC TOTAL OCCLUSION SFA. A NON-ABBOTT CATHETER FAILED TO CROSS DUE TO ANATOMY. A NEW NON-ABBOTT DEVICE SUCCESSFULLY CROSSED THE LESION AND PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED. ONCE AT THE LESION DURING DEPLOYMENT OF THE 5.5X150MM SUPERA SELF-EXPANDING STENT (SES), THE STENT WAS INADVERTENTLY PULLED BACK CAUSING ELONGATION OF THE STENT. AS SUCH, A PARTIAL DEPLOYMENT OCCURRED, AND THE STENT WAS WITHDRAWN. A NEW 6.0X150MM SUPERA SES WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23946553 ↗
• MalfunctionOct 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.5X150 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), THE WHITE TIP DETACHED FROM THE DELIVERY SYSTEM. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415475 ↗
• InjuryApr 14, 2025Difficult to Remove; Material Separation; Material Deformation; Difficult to Remove; Material Separation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 5.5X150 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED; HOWEVER THERE WAS SLIGHT WAIST NOTED IN THE STENT. THE TIP WAS NOTED TO BE IN CONTACT WITH THE RELEASED STENT AND AFTER THE STENT WAS DEPLOYED THE DELIVERY SYSTEM WAS REMOVED AND IT WAS NOTED THE TIP REMAINED IN THE ANATOMY. A CAPTURE DEVICE WAS USED TO RETRIEVE THE TIP. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21833837 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 5.50 X 150 MM SUPERA STENT WAS IMPLANTED WITHOUT ISSUE HOWEVER THE PATIENT LATER COMPLAINED OF LEG PAIN. ANGIOGRAPHY REVEALED THROMBUS WITHIN THE STENT. THROMBUS ASPIRATION WAS PERFORMED AS TREATMENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 21741162 ↗
• InjuryJun 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE 5.5X150 MM SUPERA SELF EXPANDING STENT (SES) WAS IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POST DILATED. IT WAS THEN NOTED THAT THERE WAS A PINCH IN THE MIDDLE OF THE STENT. THE STENT WAS POST DILATED AGAIN. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480348 ↗
• MalfunctionApr 18, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION, NO TORTUOSITY AND 90% STENOSIS. A 6.0X150MM 120CM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED OVER A NON-ABBOTT 0.014 GUIDE WIRE (GW) TO THE TARGET SITE. THE SUPERA STENT WAS DEPLOYED AT THE INTENDED SITE WITHOUT ISSUE. DURING WITHDRAWAL OF THE DELIVERY CATHETER, RESISTANCE WAS FELT WITH THE GW, THUS BOTH WERE REMOVED FROM THE ANATOMY INTACT AS ONE UNIT WHICH CAUSED LOSS OF ACCESS. A NEW ACCESS SITE WAS ESTABLISHED, AND A SECOND 5.5X150 120CM SUPERA SESS WAS ADVANCED OVER A NEW NON-ABBOTT 0.014 GW TO THE INTENDED TARGET SITE. THE STENT WAS DEPLOYED WITHOUT ISSUE. AGAIN DURING WITHDRAWAL, THE DELIVERY SYSTEM FELT RESISTANCE WITH THE GW AND BOTH WERE REMOVED FROM THE ANATOMY AS ONE UNIT, INTACT. 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 19136721 ↗
• MalfunctionMar 1, 2024Stretched; Activation Failure; Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT SUPERIOR FEMORAL ARTERY (SFA) THAT IS 100% STENOSED. THE VESSEL WAS PRE-DILATED WITH A 5.0X100MM NON-ABBOTT BALLOON AND A 5.5X150MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED USING THE CROSS OVER TECHNIQUE; HOWEVER, ELONGATION OCCURRED AND IT WAS NOTED THE STENT DEPLOYED IN THE GUIDING CATHETER / INTRODUCER SHEATH. IT WAS NOTED THE INCORRECT SIZE FOR THE BALLOON WAS USED. THEREFORE, THE DEVICE WAS REMOVED UNDER FLUOROSCOPY. NO TREATMENT WAS ADDED IN THIS PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18820238 ↗
• InjuryMar 1, 2024Stretched; Difficult or Delayed Activation; Material Twisted/Bent; Stretched; Difficult or Delayed Activation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND NO TORTUOSITY. A 6FRENCH (F) SHEATH WAS USED AND THE VESSEL DIAMETER SIZE WAS 5.5MM. THE VESSEL WAS PREPARED USING A BALLOON AND AN INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. NO ATHERECTOMY WAS USED. A 5.5X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED WITHOUT ISSUES. ANOTHER 5.5X150MM SUPERA SESS WAS ADVANCED AND WAS BEING DEPLOYED; HOWEVER, WHEN ABOUT 30MM LEFT COULD NOT COMPLETELY DEPLOY THE STENT. THERE WAS NO RESISTANCE WITH THE THUMBSLIDE BUT IT FELT LIKE THE RATCHET WAS NOT GRABBING OR PUSHING AT ALL. THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE. THE INTRODUCER SHEATH WAS NOT CLOSE AT ALL TO THE PROXIMAL END OF THE STENT DURING DEPLOYMENT. NO PORTION OF THE STENT WAS DEPLOYED INSIDE THE INTRODUCER. TO COMPLETE THE DEPLOYMENT OF THE STENT, THE SHAFT WAS PULLED AS THE THUMBSLIDE WAS ADVANCING WHICH ELONGATED THE PROXIMAL PORTION OF THE STENT A BIT BUT WAS IMPLANTED, HOWEVER, THE STENT WAS NOT MEASURED. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. A NITINOL STENT WAS IMPLANTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817850 ↗
• MalfunctionFeb 6, 2024Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION. DURING PREPARATION OF THE 5.5X150 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), THE DEVICE WAS LOADED ONTO A GUIDE WIRE WHICH WAS INSIDE THE ANATOMY. THE GUIDE WIRE WIRE HAD LOTS OF CONTRAST AND WAS STICKY, CAUSING RESISTANCE DURING ADVANCEMENT AND REMOVAL. WHEN THE STENT WAS PULLED OFF THE WIRE, THE WHITE TIP SEPARATED. THEREFORE, THE STENT WAS NOT USED IN THE PATIENT AND ANOTHER SAME SIZE SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 18655622 ↗
• MalfunctionAug 23, 2023Material Separation; Device Dislodged or Dislocated; Activation Failure; Material Separation; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT SUPERIOR FEMORAL ARTERY (SFA). ATHERECTOMY WAS PERFORMED TO PREP THE LESION. THE 5.5X150MM SUPERA WAS ADVANCED WITHOUT ISSUE AND THOUGHT TO BE FULLY DEPLOYED AT THE INTENDED SITE. HOWEVER, UPON REMOVAL RIGHT WHEN THE DELIVERY SYSTEM WAS OUT IT WAS NOTED THAT THE STENT CAME ALONG WITH IT AND THE STENT CAME OFF LANDED ON THE PATIENT ALONG WITH THE SEPARATED NOSECONE. NOTHING WAS LEFT IN THE PATIENT AS THIS OCCURRED OUTSIDE THE ANATOMY. THE DEVICE WAS REMOVED UNDER FLUOROSCOPY. A NEW SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 17606086 ↗
• InjuryAug 11, 2023Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 5.5X150MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED AND AN UNSPECIFIED BALLOON WAS USED FOR POST DILATATION; HOWEVER, THE STENT MAY HAVE BEEN FRACTURED AND ELONGATED BUT THERE WAS NO SEPARATION NOTED ON ANGIOGRAPHY. THE IMAGE WAS UNCLEAR DUE THE HEAVY CALCIFICATION. A PORTION OF THE STENT REMAINED IN THE TARGET LESION, WHILE A PORTION OF THE STENT WAS IN HEALTHY TISSUE; THEREFORE, AN UNSPECIFIED DELIVERY CATHETER WAS INTRODUCED AND ANOTHER UNSPECIFIED STENT WAS IMPLANTED THROUGH THE SUPERA TO TREAT THE BROKEN PORTION OF THE STENT AND THE REST OF THE TARGET LESION; HOWEVER, THE SEVERE THROMBOSIS WAS NOTED AND WAS TREATED WITH INTRA-ARTERIAL LYSIS AND THE PATIENT WAS HOSPITALIZED. THE PATIENT HAD A FOLLOW UP ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17512028 ↗
• InjuryJul 25, 2023Material Separation; Device Dislodged or Dislocated; Activation Failure; Material Separation; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, 99% STENOSED LESION IN THE LEFT SUPERIOR FEMORAL ARTERY (SFA). THE LESION WAS PRE-DILATED WITH A 5.0X100 BALLOON DISTAL TO THE SFA NEAR A PREVIOUSLY IMPLANTED STENT. THE 5.5 X 150 SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT ISSUE. THE SLIDE WAS SWITCHED TO RELEASE THE STENT AND THE NOSE CONE WAS RECAPTURED, BUT THE USER DID NOT REALIZE THAT THE SUPERA STENT NEVER RELEASED FROM THE SESS. THE SESS WAS PULLED BACK AND THIS INADVERTENTLY PULLED THE STENT INTO THE LEFT COMMON FEMORAL ARTERY AND THEN INTO THE EXTERNAL ILIAC ARTERY. IT WAS REALIZED THAT THE STENT WAS STUCK ON THE CATHETER AND WOULD NOT RELEASE. HE PULLED THE DEVICE BACK TO THE ORIGINAL ACCESS SITE AND AT THAT POINT THE STENT DISLODGED INTO THE LEFT TO RIGHT ILIAC ARTERIES AND WAS FREE FLOATING. THEY ATTEMPTED TO EMBED THE STENT WHEN THE NOSE CONE BROKE OFF AND WAS LODGED INSIDE THE SHEATH. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR BILATERAL CUT DOWNS WHERE THE SHEATH AND NOSE CONE WERE SUCCESSFULLY REMOVED. THE STENT WAS UNABLE TO BE REMOVED FROM THE ANATOMY THEREFORE TWO NON-ABBOTT STENTS WERE USED TO EMBED THE SUPERA ACROSS THE B

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17392823 ↗
• InjuryJul 24, 2023Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERIOR FEMORAL ARTERY (SFA). A 6 FR 45MM SHEATH WAS USED IN A 5.6 MM VESSEL AND AN UNSPECIFIED BALLOON WAS USED TO PRE-DILATE THE LESION. THE 5.5X150MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS THOUGHT TO BE FULLY DEPLOYED; HOWEVER, WHEN THE DELIVERY SYSTEM WAS BEING REMOVED UNDER FLUOROSCOPY THE STENT RE-ENTERED THE SHEATH; THEREFORE, THE NOSE CONE WAS SEPARATED BUT REMAINED IN THE STENT AND SHEATH. A CUT DOWN WAS PERFORMED TO RETRIEVE THE STENT. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE; HOWEVER, THERE WERE NO ADVERSE PATIENT SEQUELA. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379150 ↗
• MalfunctionJun 5, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE SUPERA STENT DEPLOYED, BUT WAS REMOVED SINCE IT WOULD NOT RELEASE FROM THE CATHETER. ANOTHER SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 17065013 ↗
• MalfunctionMar 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH NONE TORTUOSITY AND CALCIFICATION. THE 5.5X150 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED IN THE LESION WITHOUT ISSUED; HOWEVER, POST PROCEDURE WAS NOTED THAT THE SUPERA STENT WAS EXPIRED ON 9/30/2022. 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 16526495 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE 5.5X150 MM SUPERA SELF EXPANDING STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH CALCIFICATION AND 90% STENOSIS. LESS THAN 365 DAYS LATER, ON (B)(6) 2023, REVASCULARIZATION WAS PERFORMED IN THE SUPERA STENT AND THE PATIENT WAS EXPERIENCING ANGINA. ATHERECTOMY WAS PERFORMED AND THEN ANGIOPLASTY PERFORMED TO TREAT THE AREA. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 16294016 ↗