SUPERA S-60-150-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 08717648211843), received between Aug 30, 2016 and Sep 29, 2026 — classified as 50 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (38 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Activation Failure

  It was reported that the procedure was to treat a de novo lesion in the lower limb with 70% stenosis, mild calcification and mild tortuosity. The 6.0x150mm Supera self-expanding stent system (SESS) was advanced, but then during stent deployment, the stent was only able to be partially deployed. The stent could not be fully released. Therefore, the delivery system and stent were removed under fluoroscopy without issues. Another same size Supera was used to complete the procedure. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927395 ↗
• MalfunctionJul 15, 2026Stretched; Difficult or Delayed Activation; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25822270 ↗
• InjuryApr 29, 2026Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY LESION WITH RESTENOSIS. A 6X150 MM SUPERA SELF EXPANDING STENT (SES) SYSTEM WAS ADVANCED TO THE TARGET LESION AND THE STENT DEPLOYED. HOWEVER, THE THUMB SLIDE WAS NOT FULLY RETRACTED TO THE START POSITION AND LOCKED DURING REMOVAL. THEN THE NOSECONE [TIP] DISLODGED FROM THE DELIVERY SYSTEM AND THE STENT WAS ELONGATED. A SNARE WAS USED TO RETRIEVE THE SEPARATED TIP. 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 25034440 ↗
• MalfunctionNov 26, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED RIGHT SUPERIOR FEMORAL ARTERY (SFA) THAT IS 75% STENOSED. THE LESION WAS PRE-DILATATED WITH A 6X15MM UNSPECIFIED BALLOON AT 20 ATMOSPHERES. THE 6.0X150MM SUPERA SELF-EXPANDING STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, COULD ONLY PARTIALLY DEPLOY (APPROXIMATELY 4CM) AS THE THUMBWHEEL BEGAN TO FREE SPIN. THE ENTIRE SUPERA STENT SYSTEM WAS WITHDRAWN INTO THE GUIDING SHEATH AND WAS REMOVED. A 5.5 SUPERA STENT WAS USED TO SUCCESSFULLY COMPLETE TO 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 23662760 ↗
• InjuryNov 20, 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 LESION IN THE SUPERFICIAL FEMORAL ARTERY ON (B)(6) 2025. THE SUPERA STENT WAS IMPLANTED WITHOUT ISSUE. THE PATIENT RETURNED ON (B)(6) 2025 WITH LEG PAIN AND IT WAS NOTED THE SUPERA STENT WAS OCCLUDED. TREATMENT WAS PERFORMED TO OPEN UP THE STENT. PER THE PHYSICIAN, THE PATIENT STOP TAKING MEDICATION WHICH LEAD TO THE OCCLUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 23605778 ↗
• MalfunctionOct 8, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT WHEN THE 6.0X150 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS LOADED ONTO A GUIDE WIRE, THE WHITE TIP WAS FOUND TO HAVE FALLEN OFF OF THE DEVICE. THE SESS COULD NOT BE SMOOTHLY THREADED ONTO A GUIDE WIRE THAT WAS IN THE ANATOMY. ANOTHER SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23247073 ↗
• InjurySep 17, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING THE SUCCESSFUL DEPLOYMENT OF A 6X150MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) THROUGH A 6FR SHEATH, THE DISTAL END OF THE DELIVERY CATHETER WAS NOTED TO SEPARATE AFTER RESISTANCE WAS FELT DURING WITHDRAWAL. SLIGHT FORCE WAS NOTED TO BE APPLIED AND THE SEPARATED PORTION WAS SNARED FROM THE VESSEL. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077620 ↗
• MalfunctionJul 1, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 100% STENOSED. DURING ENDOVASCULAR THROMBECTOMY FOR A CHRONIC TOTAL OCCLUSION LESION EXTENDING FROM THE LEFT COMMON FEMORAL ARTERY, AN ATTEMPT WAS MADE TO DELIVER AND DEPLOY 6.0X150MM SUPERA SELF-EXPANDING STENT (SES) OVER A 0.014 HT COMMAND GUIDEWIRE, VIA A CONTRALATERAL CROSSOVER APPROACH. AFTER PRE-DILATION WITH MULTIPLE NON-ABBOTT BALLOONS, RESISTANCE WAS FELT AND THE THUMB SLIDE OF THE SUPERA SES COULD NOT BE FULLY ADVANCED. THE SUPERA SES WAS PRESUMED TO PARTIALLY DEPLOY AT THE LESION SITE DURING DEVICE INSERTION. AN UNSPECIFIED DRUG-ELUTING STENT 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 22375048 ↗
• InjuryMay 12, 2025Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X150MM SUPERA SELF EXPANDING STENT SYSTEM WAS ADVANCED TO THE TARGET LESION; HOWEVER DURING DEPLOYMENT, THE THUMBSLIDE BROKE AND WOULD NOT ROTATE AFTER HALF OF THE STENT WAS DEPLOYED. PEDAL ACCESS HAD TO BE OBTAINED AND A 7.0 VIATRAC BALLOON WAS USED TO ANCHOR THE PARTIALLY DEPLOYED STENT TO PREVENT IT FROM ELONGATING FROM THE SFA TO THE COMMON ARTERY. THE GROIN WAS ACCESSED AND THE PHYSICIAN BROKE THE HANDLE IN ORDER TO DEPLOY THE REST OF THE STENT. T HE SHEATH WAS PLACED OVER THE NOSE CONE AND THE SYSTEM WAS PULLED OUT AS A UNIT. THE SUPERA STENT WAS DEPLOYED AT THE INTENDED SITE. THERE WERE NO ADVERSE PATIENT EFFE CTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003710 ↗
• InjuryApr 9, 2025Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X150MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION; HOWEVER DURING THE PROCESS OF DEPLOYING THE STENT, IT ONLY RELEASED HALF WAY AND THE TIP OF THE DELIVERY SYSTEM DETACHED. THE SES WITH THE PARTIALLY DEPLOYED STENT WAS REMOVED. OUTSIDE THE ANATOMY THE STENT WAS COMPLETELY DEPLOYED. THE TIP OF THE SES WAS FOUND STUCK IN THE POSTERIOR TIBIAL ARTERY. A SUCTION CATHETER WAS USED TO REMOVE THE DETACHED TIP. ANOTHER STENT 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 21805252 ↗
• MalfunctionMar 18, 2025Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X150MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT DIFFICULTY WAS MET AS THE THUMBSLIDE STOPPED MOVING THEREFORE BOTH LOCKS WERE UNLOCKED AND THE SESS WAS PULLED BACK TO COMPLETELY DEPLOY THE 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 21630459 ↗
• InjuryFeb 20, 2025Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH NO CALCIFICATION OR TORTUOSITY. THE 6X150 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) DEPLOYED THE STENT AND THERE WAS POOR FLOW AFTER DEPLOYMENT. DURING REMOVAL OF THE DELIVERY SYSTEM THERE WAS SOME RESISTANCE AND THE STENT ELONGATED BUT REMAINS IN THE TARGET LESION. IT WAS FOUND THAT THE TIP OF THE DELIVERY SYSTEM DETACHED AFTER DEPLOYMENT. THE PATIENT WAS SENT TO SURGERY FOR A CUT DOWN TO REMOVE THE TIP AND THEN A FEMORAL/POPLITEAL BYPASS WAS PERFORMED TO TREAT THE TARGET LESION. THE PATIENT IS DOING FINE NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21425973 ↗
• MalfunctionFeb 18, 2025Break; Difficult to Advance; Activation Failure; Break; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6X150MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS ATTEMPTED TO BE ADVANCED INTO THE ANATOMY OVER A .018" NON-ABBOTT GUIDEWIRE; HOWEVER, THE SES COULD NOT BE ADVANCED PASSED THE 6F INTRODUCER SHEATH. THE SES WAS REMOVED AND REPLACED WITH ANOTHER STENT THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. SUBSEQUENT TO THE INITIALLY REPORTED INFORMATION, THE DEVICE WAS RECEIVED AND THE ANALYSIS REVEALED THAT THE STENT IMPLANT WAS EXPOSED 4 MILLIMETERS (MM) FROM THE DISTAL END OF THE SHEATH. THE STRUTS AT THE DISTAL END OF THE STENT IMPLANT WERE BROKEN. FOLLOW-UP WAS PERFORMED WITH THE SITE; HOWEVER, THE SITE WAS NOT AWARE OF THE REPORTED DAMAGES FOUND IN THE RETURNED DEVICE ANALYSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396400 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED IN A RESEARCH ARTICLE CASE SUMMARY THAT THE PATIENT PRESENTED WITH LEFT SIDED CLAUDICATION. IMAGING REVEALED OCCLUSION OF THE DISTAL SUPERFICIAL FEMORAL ARTERY TO THE MID POPLITEAL ARTERY WITH CALCIFICATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO GUIDE PARALLEL GUIDE WIRES TO THE CALCIFIED LESION. A 6X150 MM SUPERA SELF EXPANDING STENT WAS DEPLOYED. THREE WEEKS LATER, THE PATIENT DEVELOPED SEVERE PAIN AND EDEMA IN THE LEFT LOWER EXTREMITY. IMAGING REVEALED A LARGE PSEUDOANEURYSM AND TEARING OF THE STENT IMPLANTATION SITE AT THE EDGE OF THE VESSEL. THE STENT WAS FLOATING WITHIN THE ANEURYSM. A NON-ABBOTT STENT GRAFT WAS DEPLOYED TO FULLY COVER AND BLOCK BLOOD FLOW TO THE ANEURYSM. THERE WAS NO STENT FRACTURE. ADDITIONAL INFORMATION CAN BE FOUND IN THE ARTICLE "HUGE PSEUDOANEURYSM IN SEVERE CALCIFIED POPLITEAL ARTERY OCCLUSION EARLY AFTER SUPERA STENT IMPLANTATION".

  Patient problems: Pain; Pseudoaneurysm; Swelling/ Edema

  MAUDE report 21350468 ↗
• InjuryFeb 3, 2025Activation Failure; Activation Failure

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED THAT THE BALLOON WAS REMOVED FROM THE ANATOMY AFTER PRE-DILATATION AND THEN RE-ADVANCED IN ORDER TO CRIMP THE STENT TO THE GUIDING CATHETER TO BE REMOVED FROM THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296637 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION, WHEN THE 6X150MM SUPERA PERIPHERAL STENT WAS REMOVED FROM THE PACKAGING IT WAS NOTED THE TIP WAS BROKEN. THE DEVICE WAS REPLACED WITH ANOTHER SUPERA STENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600315 ↗
• MalfunctionAug 20, 2024Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  MEDWATCH REPORT UF/IMPORTER REPORT #(B)(4) DESCRIBE THE EVENT OR PROBLEM: STENT DID NOT FULLY DEPLOY AND WAS STUCK IN SHEATH; PHYSICIAN WAS ABLE TO REMOVE. NO PATIENT HARM. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? RIGHT LOWER EXTREMITY ANGIOPLASTY WITH STENTING ATHERECTOMY AND ASSOCIATED PROCEDURES WHAT PROBLEM DID THE USER HAVE: 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 KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005567 ↗
• MalfunctionAug 8, 2024Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THE SUPERFICIAL FEMORAL ARTERY WAS HEAVILY CALCIFIED, HEAVILY TORTUOUS AND 91% STENOSED. THE VESSEL DIAMETER WAS 6MM. A 6FX100CM SHEATH WAS USED. THE VESSEL WAS PRE-DILATED WITH A 6MM BALLOON TO 6 ATMOSPHERES. ATHERECTOMY WAS NOT USED. DURING DEPLOYMENT OF THE 6.0X150MM SUPERA STENT, THE THUMB SLIDE WAS NOT ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE. THE DOCTOR FORGOT TO OPEN THE RELEASE LOCK AFTER RELEASING THE STENT, THEREFORE WHEN THE DELIVERY SYSTEM WAS REMOVED THE PARTIALLY DEPLOYED STENT WAS ALSO REMOVED FROM THE ANATOMY WITH THE SYSTEM. A NEW SAME SIZE SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945471 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2023 A 6.0X150MM SUPERA STENT WAS IMPLANTED IN THE DISTAL LEFT SUPERIOR FEMORAL ARTERY. ON (B)(6) 2024, IT WAS CONFIRMED VIA ANGIOGRAM THAT THE STENT THROMBOSED. THROMBECTOMY WAS PERFORMED USING LASER. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19143145 ↗
• 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 19137640 ↗
• InjuryMar 7, 2024Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS HEAVILY CALCIFIED. DURING DEPLOYMENT, THE 6.0X150 SUPERA STENT WOULD NOT FULLY RELEASE FROM THE STENT SYSTEM. THE LEVER WAS MOVED BACK AND FORTH IN ORDER TO DEPLOY THE STENT. DURING DEPLOYMENT AND WITHDRAWAL, THE TIP CAME OFF. THE TIP WAS SNARED FROM INSIDE THE SHEATH. THE PATIENT HAD A GOOD OUTCOME AND IS DOING FINE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859753 ↗
• InjuryDec 11, 2023Difficult to Remove; Material Separation; Mechanical Jam; Difficult to Remove; Material Separation; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY. (SFA). A SUPERA STENT WAS IMPLANTED AT THE TARGET LESION WITHOUT ISSUE. THEN A 6.0X150MM SUPERA STENT WAS ADVANCED DISTAL OF THE PREVIOUSLY IMPLANTED STENT AND THE STENT WAS IMPLANTED. WHEN RETRACTING THE DELIVERY SYSTEM TO BE REMOVED, RESISTANCE WAS NOTED WITH THE THUMBSLIDE, AND WHILE PULLING BACK THE DELIVERY SYSTEM A BREAK OCCURRED. UNDER FLUOROSCOPY, THE DISTAL END OF THE DELIVERY SYSTEM (NEAR THE NOSE CONE) WAS OBSERVED TO BE SEPARATED; HOWEVER, REMAINED ON THE GUIDE WIRE. A GUIDE CATHETER WAS USED TO ENTRAP THE SEPARATED PORTION AND REMOVE IT FROM THE PATIENT. BOTH SUPERA REMAINED IMPLANTED WITH NO ISSUES. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307622 ↗
• InjuryDec 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED DE NOVO LESION IN THE RIGHT COMMON FEMORAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 6.0X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED; HOWEVER, WHEN THE DEPLOYMENT MECHANISM WAS UNLOCKED TO RELEASE THE STENT FROM THE DELIVERY SHEATH THE STENT FAILED COMPLETELY TO RELEASE. THEREFORE, A LARGE CATHETER WAS USED TO REMOVE THE SUPERA STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. ANOTHER SUPERA WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275087 ↗
• MalfunctionDec 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE AND DURING PREPARATION THE TECH IN THE CATH LAB TECH MISTAKENLY PULLED OFF THE TIP OF THE 6.0X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) AS THE TECH THOUGHT THE TIP OF THE SESS WAS THE STYLET OF THE DEVICE. THE SESS WAS NO USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SUPERA STENT WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271253 ↗
• InjuryOct 16, 2023Difficult to Remove; Material Separation; Activation Failure; Difficult to Remove; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. THE LESION WAS PREPPED WITH TWO 5X200MM AND 6X200MM ARMADA 35 BALLOON AT 8 TO 12 ATMOSPHERES FOR 2-3 MINUTES. THE 6.0X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS 2/3 INTO DEPLOYING THE STENT WHEN IT WAS NOTED THE TIP OF THE DELIVERY CATHETER SEPARATED. THE STENT WAS REMOVED WITH THE DELIVERY SYSTEM UNDER FLUOROSCOPY. AN ATTEMPT WAS MADE TO REMOVE THE SEPARATED TIP; HOWEVER, IT WAS UNSUCCESSFUL AS THE UNSPECIFIED GUIDE WIRE WAS NOT ABLE TO PUSH THE SEPARATED TIP AS IT WAS FIRMLY ENTRENCHED. THEREFORE, THE TIP OF THE DELIVERY SYSTEM REMAINED EMBEDDED, AND SURGERY WAS PERFORMED TO REMOVE THE SEPARATED TIP. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946477 ↗