SUPERA S-60-080-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648211812), received between Aug 23, 2016 and Apr 22, 2026 — classified as 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POPLITEAL ARTERY. THE 6.0X80MM SUPERA SELF-EXPANDING STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND ONLY PARTIALLY DEPLOYED. THE SDS WAS REMOVED AND AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958547 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6.0X80X120 SUPERA STENT WAS IMPLANTED IN THE LEFT POPLITEAL ARTERY DUE TO 75% STENOSIS. POST PROCEDURE, PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY CONSISTING OF PLAVIX 75MG AND ASPIRIN 81MG. A FOLLOW UP PERCUTANEOUS INTERVENTION WAS SCHEDULED AND PERFORMED ON (B)(6) 2024. DURING THIS PROCEDURE, IN-STENT RESTENOSIS OF THE SUPERA STENT WAS DISCOVERED, ALTHOUGH THE PATIENT REMAINED ASYMPTOMATIC. THEREFORE, LASER ATHERECTOMY AND AN UNSPECIFIED DRUG-COATED BALLOON WERE USED AS TREATMENT AND THE STENT WAS CONFIRMED TO BE PATENT. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20465823 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS DIALYZED AND HAD CHRONIC LIMB THREATENING ISCHEMIA AND THERE WAS OCCLUSION AND THROMBOSIS BELOW THE KNEE NOTED BY THE PHYSICIAN. THE 6X80 MM SUPERA SELF EXPANDING STENT (SES) WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO POPLITEAL ARTERY AND A NON-ABBOTT STENT WAS IMPLANTED IN THE MID SFA. THE PATIENT COMPLAINED OF PAIN THE NEXT DAY BUT WAS DISCHARGED HOME. THE LESION APPEARED GOOD ONE WEEK AFTER THE PROCEDURE AND TENDERNESS IS NOTED. ABOUT TWO WEEKS AFTER IMPLANT, THERE WAS AN INFLAMMATORY RESPONSE NOTED IN THE LESION CONFIRMED BY COMPUTED TOMOGRAPHY (CT). A HEMATOMA IS PRESENT, DUE TO EITHER ALLERGIC REACTION, INFECTION AROUND THE LESION OR UNCONFIRMED WIRE PERFORATION. NO ADDITIONAL TREATMENT WAS PROVIDED. WHEN TREATMENT OF THE OPPOSITE FOOT IS PERFORMED IN THE FUTURE, THE PHYSICIAN PLANS TO CHECK FOR SUPERA ALLERGIC REACTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; Hypersensitivity/Allergic reaction; Pain; Unspecified Infection

  MAUDE report 19967067 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0X80MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WHILE FLUSHING THE SYSTEM, THE NOSE CONE SEPARATED FROM THE SES. 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 19805132 ↗
• InjuryMay 16, 2023Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT AT THE TIME OF DEPLOYMENT, THE SUPERA STENT WAS THOUGHT TO BE WELL APPOSED TO THE VESSEL WALL, BUT SINCE THE STENT MIGRATED, THE CAUSE OF THE MIGRATION MAY POSSIBLY BE DUE TO STENT UNDER-SIZING THAT WAS NOT NOTED AT THE TIME OF IMPLANTATION. ADDITIONALLY, IT IS UNLIKELY THAT THE SUPERA STENT, WHICH MIGRATED FROM THE SITE OF IMPLANTATION (DISTAL POPLITEAL TO TIBIOPERONEAL TRUNK) TO THE ANTERIOR TIBIAL ARTERY (ATA) CAUSED OR CONTRIBUTED TO THE LOWER LIMB ARTERIAL OCCLUSION AS THERE WAS BRISK ARTERIAL FLOW NOTED THROUGH THE ATA. THE OCCLUSION WAS NOTED IN THE POSTERIOR TIBIAL ARTERY (PTA) DUE TO PROGRESSION OF DISEASE AND RESTENOSIS IN THE AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 16942521 ↗
• InjuryAug 29, 2022Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. ATHERECTOMY WAS NOT USED AND A 6FR SHORT SHEATH WAS USED FOR THE PROCEDURE. PRE-DILATATION WAS PERFORMED WITH A 6.0X80 MM NON-ABBOTT BALLOON AND THE 6.0X80 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS THOUGHT TO HAVE DEPLOYED THE STENT. THE DELIVERY SYSTEM WAS BEING REMOVED WHEN THE TIP WAS NOTED TO HAVE SEPARATED. TO RETRIEVE THE SEPARATED TIP, THE DELIVERY SYSTEM WAS REMOVED BUT THE STENT WAS FOUND TO HAVE DEPLOYED IN THE SHEATH. THE STENT ENDED UP DEPLOYING NEAR THE FEMORAL ACCESS SITE WHILE THE DELIVERY SYSTEM WAS PULLED OUT OF THE ANATOMY. THE SEPARATED TIP WAS THEN RETRIEVED VIA SNARE AND THE DEPLOYED STENT WAS REMOVED SURGICALLY. A NON-ABBOTT STENT TREATED THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312620 ↗
• InjuryApr 7, 2022Difficult to Remove; Material Separation; Stretched; Patient-Device Incompatibility; Difficult to Advance; Mechanical Jam; Activation Failure; Difficult to Remove; Material Separation; Stretched; Patient-Device Incompatibility; Difficult to Advance; Mechanical Jam; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047219 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 80% STENOSED LESION IN THE LEFT POPLITEAL ARTERY. A 6X80 SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS IMPLANTED ON (B)(6) 2021, WITHOUT ISSUE. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH RESTENOSIS. A 6X40MM ARMADA 18 BALLOON DILATATION CATHETER WAS USED TO TREAT THE RESTENOSIS WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 13256410 ↗
• InjuryDec 3, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 60% STENOSED LESION IN THE POPLITEAL ARTERY. A 6X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DEPLOYMENT WAS INITIATED BUT THE STENT DID NOT FULLY DEPLOY AND REMAINED PARTIALLY IN THE SHEATH. DURING REMOVAL OF THE DELIVERY SYSTEM WITH THE STENT ATTACHED, THE STENT RELEASED FROM THE SYSTEM AND BECAME FREE-FLOATING IN THE POPLITEAL ARTERY. A SNARE WAS USED TO CAPTURE THE STENT AND WAS REMOVED WITHOUT FURTHER ISSUE. THE PATIENT REMAINED IN GOOD CONDITION AND THE PROCEDURE WAS ABORTED WITHOUT USING ANOTHER STENT OR DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 12927211 ↗
• InjuryNov 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 A 6X80MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS IMPLANTED WITHOUT ISSUE TO COVER THE FRACTURED NON-ABBOTT STENT IN THE RIGHT SUPERIOR FEMORAL ARTERY (SFA). GOOD RESULTS WERE ACHIEVED. ON (B)(6) 2020, THE PATIENT PRESENTED WITH LEG PAIN AND ANGIOGRAPHY SHOWED THAT THE SUPERA STENT WAS FRACTURED. IN THE PHYSICIAN¿S OPINION, IT IS POSSIBLE THAT THE CAUSE OF THE SUPERA STENT FRACTURE WAS DUE TO THE NON-ABBOTT FRACTURED STENT BLOCKING THE MIMETIC MOVEMENT OF THE SUPERA STENT. IF THE LESION WAS TREATED BY ONLY THE SUPERA STENT, IT IS POSSIBLE THAT THE FRACTURE WOULDN¿T HAVE OCCURRED. A NON-ABBOTT STENT WAS IMPLANTED IN THE SUPERA STENT WITH GOOD RESULTS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 12763591 ↗
• MalfunctionApr 1, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION.. AN HT STEELCORE 18 GUIDE WIRE WAS ADVANCED TO THE TARGET LESION, AND PRE-DILATATION WAS SUCCESSFULLY PERFORMED. THEN TWO UNSPECIFIED SUPERA STENTS WERE DEPLOYED. A THIRD SUPERA SELF-EXPANDING STENT DELIVERY SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION, AND THE STENT WAS DEPLOYED. HOWEVER, DURING REMOVAL OF THE SESS, THE DELIVERY SYSTEM WAS STUCK TO THE GUIDE WIRE AND WIRE ACCESS WAS LOST. BOTH, THE SESS AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. THE PROCEDURE ENDED AT THIS POINT. 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 11604581 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. A SUPERA STENT WAS IMPLANTED ON (B)(6) 2019. FIVE MONTHS LATER ON (B)(6) 2020, THE PATIENT FELT SYMPTOMATIC AND WAS REHOSPITALIZED. VIA ANGIOGRAPHY IN-STENT RESTENOSIS WAS NOTED. THE RESTENOSIS WAS TREATED WITH BALLOON DILATATION AND WAS RE-STENTED. THE PATIENT IS FINE AND NO ADVERSE PATIENT SEQUELA WAS REPORTED. THE ACCOUNT COULD NOT PROVIDE FURTHER DETAILS ABOUT THE PATIENTS SYMPTOMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9702055 ↗
• MalfunctionOct 15, 2019Product Quality Problem; Contamination /Decontamination Problem; Product Quality Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE DISTRIBUTION CENTER WAS PERFORMING INSPECTIONS ON SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEMS (SESS). THE POSITION OF THE FLUSH PORT OF A 6.0 X 80 SUPERA SESS WAS ABNORMAL, AND THE TYVEK POUCHES OF A 6.5 X 40 CM AND A 6.5 X 80 CM SUPERA SESS WERE DEFECTED. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THAT THERE WAS AN UNKNOWN MATERIAL AT THE PROXIMAL END OF THE SHEATH FLUSH PORT OF THE 6.0X80 SUPERA.

  Patient problems: No Patient Involvement

  MAUDE report 9192539 ↗
• InjurySep 27, 2019Stretched; Improper or Incorrect Procedure or Method; Activation Failure; Stretched; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). AN UNSPECIFIED GUIDE WIRE AND NON-ABBOTT INTRODUCER SHEATH WERE ADVANCED TOWARDS THE LESION, AND RE-STENOSIS WAS NOTED IN AN UNSPECIFIED PREVIOUSLY IMPLANTED STENT. LASER ATHERECTOMY WAS PERFORMED, AND AN UNSPECIFIED 6X120MM BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 14 ATMOSPHERES. A 6X80MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED, AND WAS ATTEMPTED TO BE REMOVED WITHOUT FLUOROSCOPY. IT WAS NOTED UNDER FLUROSCOPY THAT THE STENT WAS STILL CONNECTED TO THE DELIVERY SYSTEM AND BECAME ELONGATED TO THE END OF THE INTRODUCER SHEATH. AN UNSPECIFIED 3X40MM BDC WAS INFLATED TO PUSH THE STENT AGAINST THE SHEATH'S WALL AND REMOVED THE STENT WITH THE BDC. AN UNSPECIFIED ABSOLUTE PRO STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9129475 ↗
• InjurySep 16, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED 4MM BALLOON. A 6.0X80MM SUPERA SELF-EXPANDING STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND ATTEMPTED TO BE DEPLOYED. AS THE STENT WAS BEING DEPLOYED, THE NOSE CONE (CATHETER TIP) FELL OFF. IT WAS DECIDED TO REMOVE THE PARTIALLY DEPLOYED STENT (STILL WITHIN THE SHEATH) AND ABORT THE PROCEDURE. THE NOSE CONE REMAINS IN AN UNKNOWN LOCATION IN THE ANATOMY. THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9071599 ↗
• MalfunctionAug 16, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6 X 80 MM SUPERA SELF-EXPANDING STENT SYSTEM WAS ADVANCED WITHOUT RESISTANCE AND THE STENT WAS FULLY DEPLOYED. THE NOSE CONE SEPARATED FROM THE DELIVERY CATHETER AND BECAME STUCK IN THE STENT. THE NOSE CONE WAS RETRACTED INTO THE SHEATH OF THE SUPERA AND THE SHEATH WAS REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8902775 ↗
• MalfunctionMay 20, 2019Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), WITH A VESSEL DIAMETER OF 5.5 MM. THE RIGHT SFA HAD BEEN PREVIOUSLY STENTED ON AN UNKNOWN DATE. THE VESSEL WAS PREPARED WITH A 6.0MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. THE 6.0X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT ONLY PARTIALLY DEPLOYED. THE STENT DELIVERY SYSTEM AND PARTIALLY DEPLOYED STENT WERE RETRACTED INTO THE 6F SHEATH AND THE ENTIRE SESS WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT ISSUE. NO FURTHER TREATMENT WAS PROVIDED, AND THE PROCEDURE WAS ABORTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626223 ↗
• InjuryApr 26, 2019Difficult to Remove; Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult to Remove; Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 99% STENOSED, HEAVILY CALCIFIED LESION IN THE NARROW, MILDLY TORTUOUS PROXIMAL FEMORAL ARTERY. THE LESION WAS PRE-DILATED WITH MULTIPLE BALLOON CATHETERS AND A 6.0MM SUPERA WAS DEPLOYED IN THE DISTAL LESION. ANOTHER 6.0X80MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO DEPLOY AT THE PROXIMAL END OF THE TARGET LESION HOWEVER THE STENT WAS NOT ABLE TO BE COMPLETELY DEPLOYED WITH THE THUMB SLIDE. THE PHYSICIAN TRIED TO SLIDE THE DEPLOYMENT LOCK, BUT THERE WAS NO DIFFERENCE. A NON-ABBOTT 6FR SHEATH WAS ADVANCED TO RETRIEVE THE SESS. RESISTANCE WAS MET RETRACTING THE SESS AND THE TIP OF THE DEVICE CAUGHT ON THE SHEATH, CAUSING IT TO SEPARATE. THE SUPERA STENT WAS ABLE TO BE COMPLETELY DEPLOYED DURING RETRACTION AND THE TIP WAS RETRIEVED WITH A SNARE DEVICE. THE STENT WAS ULTIMATELY IMPLANTED IN THE INTENDED AREA. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8558568 ↗
• InjuryJul 31, 2018Material Separation; Migration; Material Separation; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A VESSEL DIAMETER OF 6.5MM. A 6F NON-ABBOTT INTRODUCER SHEATH WAS PLACED AT THE LEFT COMMON FEMORAL ARTERY (CFA) AND AN UNSPECIFIED .018 GUIDE WIRE WAS ADVANCED TO THE LESION. PRE-DILATATION WAS PERFORMED AND A 6.0X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE STENT WAS DEPLOYED WITHOUT ANY NOTED DIFFICULTY WITH THE THUMBSLIDE. THE THUMBSLIDE WAS FULLY RETRACTED TO THE START POSITION; HOWEVER, THE PHYSICIAN COULD NOT RECALL IF BOTH THE SYSTEM AND DEPLOYMENT LEVERS WERE LOCKED PRIOR TO REMOVAL. THE SESS WAS REMOVED UNDER FLUOROSCOPY WITHOUT REPORTED RESISTANCE; HOWEVER, THE STENT WAS NOTED TO HAVE MOVED A COUPLE OF CENTIMETERS FROM THE DEPLOYED LOCATION. DURING SESS REMOVAL FROM THE PATIENT ANATOMY, THE TIP DETACHED FROM THE SESS INSIDE THE SFA AND THE SESS CAUSED A PERFORATION AT THE LEFT CFA. A COVERED STENT WAS IMPLANTED TO TREAT THE PERFORATION IN THE LEFT CFA. ADDITIONALLY, AN ATTEMPT TO RETRIEVE THE DETACHED TIP WAS MADE BY PLACING AN 8F SHEATH AT THE RIGHT CFA. A SNARE DEVICE WAS ADVANCED AND THE TI

  Patient problems: Perforation; Vessel Or Plaque, Device Embedded In

  MAUDE report 7737598 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017,A SUPERA STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL ARTERY (SFA) THAT WAS 100% STENOSED. ON (B)(6) 2017, A SUPERA STENT WAS IMPLANTED IN THE LEFT SUPERFICIAL ARTERY THAT WAS 95% STENOSED. ON (B)(6) 2017, THE PATIENT REPORTED HAVING SEVERE PAIN IN THE LEFT LEG WHICH MADE IT VERY DIFFICULT TO WALK. ON (B)(6) 2017, AN ADDITIONAL SUPERA STENT AND A NON-ABBOTT STENT WERE IMPLANTED IN THE LEFT SFA ARTERY AS IT WAS NOTED THROUGH ANGIOGRAPHY THAT THE PREVIOUSLY IMPLANTED SUPERA STENT HAD BECOME RESTENOSED. AFTER THE PROCEDURE, THE PHYSICIAN PRESCRIBED THE PATIENT WITH MEDICATION, WHICH THE PATIENT CONTINUES TO TAKE PRESENTLY. INITIALLY, LEFT LEG PAIN WAS ELIMINATED AFTER THE PROCEDURE ON (B)(6) 2017. MINOR PAIN EMERGED AGAIN IN THE LEFT CALF IN (B)(6) 2018. DURING AN ARTERIAL ULTRASOUND ON (B)(6) 2018, THE PHYSICIAN CONFIRMED THAT THE PULSE IN THE LEFT ANKLE HAD WEAKENED. PHYSICIAN DOES NOT BELIEVE AN ADDITIONAL INTERVENTION ON THE LEFT LEG IS NECESSARY. IN (B)(6) 2018, THE PATIENT REPORTED HAVING VERY SEVERE PAIN IN HER RIGHT CALF AND DIFFICULTY WALKING. THEN ON (B)(6) 2018, AN ARTERIAL ULTRASOUND WAS PERFORMED ON THE RIGHT LEG BECAUSE OF INCREASED PA

  Patient problems: Diminished Pulse Pressure; Pain

  MAUDE report 7504892 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2017 WAS PERFORMED TO TREAT LESIONS LOCATED IN THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES. THERE WAS MILD TORTUOSITY AND MILD CALCIFICATION PRESENT PRIOR TO STENTING. TWO SUPERA STENTS (6.0 X 80 MM AND 6.0 X 100 MM) STENTS WERE DEPLOYED FOR TREATMENT OF THE LESIONS. ON (B)(6) 2018, THE PATIENT BEGAN EXPERIENCING PAIN AT REST AND CLAUDICATION AND IT WAS CONFIRMED THAT BOTH SUPERA STENTS HAD OCCLUDED. THE PATIENT IS BEING REEVALUATED AT THIS TIME; HOWEVER, NO TREATMENT HAS BEEN PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Pain

  MAUDE report 7184626 ↗
• MalfunctionAug 23, 2016Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED SUPERFICIAL FEMORAL ARTERY. THE SUPERA WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED SUCCESSFULLY. HOWEVER, WHEN THE SUPERA WAS BEING WITHDRAWN FROM THE PATIENT ANATOMY, THE DEVICE BUMPED THE SHEATH AND THE TIP SEPARATED. UNDER FLUOROSCOPY, THE TIP WAS NOTED BE NEXT TO THE STENT IMPLANT AND STILL ON THE GUIDE WIRE; THEREFORE, THE TIP WAS RETRIEVED WHEN THE GUIDE WIRE WAS WITHDRAWN FROM THE PATIENTS ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5896918 ↗