SUPERA S-55-040-120-P6 (UDI 08717648226069)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648226069), received between Dec 17, 2019 and Jan 28, 2026 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Stretched; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SEVERELY CALCIFIED AND TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 5.50X40MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT THE STENT BECAME ELONGATED THEREFORE THE SES WITH THE PARTIALLY DEPLOYED STENT WAS REMOVED. A NEW DEVICE 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 24200117 ↗
• MalfunctionDec 18, 2025Premature Activation; Material Separation; Premature Activation; Material Separation

  IT WAS REPORTED THAT DURING PREP OF THE 5.5X40 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), WHEN THE DEVICE WAS BEING WIPED, THE NOSE CONE WAS INADVERTENTLY PULLED OFF AND THE STENT PREMATURELY DEPLOYED AND WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. A NEW SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842583 ↗
• InjuryMay 9, 2025Break; Break

  IT WAS REPORTED IN AN ARTICLE THAT AN 86-YEAR-OLD WOMAN PRESENTED WITH INTERMITTENT CLAUDICATION AFTER 6 MONTHS OF SUPERA STENT IMPLANTATION. ULTRASONOGRAPHY DEMONSTRATED POPLITEAL ARTERY OCCLUSION SECONDARY TO SUPERA STENT FRACTURE. FLUOROSCOPY REVEALED THAT THE STENT HAD FRACTURED AT THE SITE CLOSEST TO THE ARTIFICIAL KNEE JOINT AND MIGHT HAVE BEEN IN CONTACT WITH A VESSEL. IN ADDITION, THE POPLITEAL ARTERY WAS SLIGHTLY DEVIATED MEDIALLY IN THE P2 SEGMENT, SUGGESTING POPLITEAL ARTERY ENTRAPMENT SYNDROME. BECAUSE ADDITIONAL STENTING WAS CONSIDERED A RISK FOR FURTHER STENT FAILURE, IT WAS DECIDED TO COMPLETE ENDOVASCULAR TREATMENT WITH BALLOON ANGIOPLASTY ALONE AND THEN BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE LISTED IN THE ARTICLE TITLED, "EARLY SUPERA STENT FRACTURE AFTER TREATMENT OF POPLITEAL ARTERY OCCLUSION CAUSED BY ARTIFICIAL KNEE JOINT: A CASE REPORT".

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 21995773 ↗
• InjuryApr 29, 2025Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT TIBIOPERONEAL TRUNK THAT IS 90% STENOSED. THE VESSEL WAS PREPPED WITH AN UNSPECIFIED 5X40MM BALLOON INFLATED TO 6 ATMOSPHERES. A 5.5X40MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS DEPLOYED; HOWEVER, WHEN ATTEMPTING TO REMOVE THE SUPERA DELIVERY SYSTEM UNDER FLUOROSCOPY, RESISTANCE WAS FELT. THE STENT WAS OBSERVED TO BE CONTAINED IN THE SHEATH AND COULD NOT BE REMOVED FROM THE SHEATH. THE STENT WAS WITHDRAWN SLOWLY BY PULLING THE SHEATH BACK, AND THEN CUTTING THE SHEATH OUTSIDE THE BODY, PIECE BY PIECE TO REMOVE THE STENT. THE LESION WAS RE-WIRED AND EXCHANGED WITH A 6X11 SHEATH WHICH WAS EXCHANGED AGAIN WITH A 6X45 SHEATH. A NEW SUPERA AND WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928422 ↗
• InjuryMay 9, 2024Adverse 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 CALCIFIED, STENOSED AND SHORT SEGMENT OCCLUSION OF THE SFA TO THE PROXIMAL POPLITEAL ARTERY. A 6FR GUIDE CATHETER PLACED FOLLOWED BY A .014 COMMAND GUIDE WAS ADVANCED WITHOUT ISSUE THEN INTRAVASCULAR ULTRASOUND WAS PERFORMED. A 4.0X40MM BALLOON DILATED THE LESION AND THE GUIDE WIRE WAS CHANGED TO A .018 NON-ABBOTT GUIDE WIRE WITH THE ADVANCEMENT OF 5.5X40MM SUPERA STENT. THE STENT WAS DEPLOYED; HOWEVER, STENT WITHOUT SUFFICIENT EXPANSION AND INVAGINATION OCCURRED. THEREFORE, THE STENT WAS EXPLANTED USING A .014 WIRE AND A 7MM SNARE CATHETER. A NEW 5.5X40MM SUPERA STENT WAS PLACED AND POST DILATATED WITH A 5X40MM BALLOON. A NON-FLOW LIMITING DISSECTION WAS NOTED AT THE PROXIMAL PORTION OF THE STENT; HOWEVER, AFTER THE BALLOON DILATATION IT WAS CONFIRMED, WITHOUT RESIDUAL STENOSIS AND PROCEDURE COMPLETED.

  Patient problems: Vascular Dissection

  MAUDE report 19281518 ↗
• InjuryMay 9, 2024Patient-Device Incompatibility; Material Deformation; Patient-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED, STENOSED AND SHORT SEGMENT OCCLUSION OF THE SFA TO THE PROXIMAL POPLITEAL ARTERY. A 6FR GUIDE CATHETER PLACED FOLLOWED BY A .014 COMMAND GUIDE WAS ADVANCED WITHOUT ISSUE THEN INTRAVASCULAR ULTRASOUND WAS PERFORMED. A 4.0X40MM BALLOON DILATED THE LESION AND THE GUIDE WIRE WAS CHANGED TO A .018 NON-ABBOTT GUIDE WIRE WITH THE ADVANCEMENT OF 5.5X40MM SUPERA STENT. THE STENT WAS DEPLOYED; HOWEVER, STENT WITHOUT SUFFICIENT EXPANSION AND INVAGINATION OCCURRED. THEREFORE, THE STENT WAS EXPLANTED USING A .014 WIRE AND A 7MM SNARE CATHETER. A NEW 5.5X40MM SUPERA STENT WAS PLACED AND POST DILATATED WITH A 5X40MM BALLOON. A NON-FLOW LIMITING DISSECTION WAS NOTED AT THE PROXIMAL PORTION OF THE STENT; HOWEVER, AFTER THE BALLOON DILATATION IT WAS CONFIRMED, WITHOUT RESIDUAL STENOSIS AND PROCEDURE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280932 ↗
• InjuryJan 18, 2024Material Separation; Improper or Incorrect Procedure or Method; Defective Device; Migration; Material Separation; Improper or Incorrect Procedure or Method; Defective Device; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY THAT HAD BEEN DISSECTED DURING PRE-DILATATION BY A 5.0X40MM BALLOON. ONCE THE 5.5X40MM SUPER SELF-EXPANDING STENT WAS DEPLOYED THE THUMBSILDE WAS MOVE BACK TO STARTING POSITION, LOCKED, REMOVED DEVICE, IT WAS THEN NOTICED THE NOSECONE WAS NOT ON THE DEVICE. FLURORSCOPY WAS PERFORMED AND THE NOSECONE WAS OBSERVED TO BE ATTACHED TO THE STENT. THE DEVICE WAS REINSERTED AND PULLED GUIDE WIRE WITH DEVICE TOGETHER, WHICH WAS ABLE TO REMOVE THE NOSECONE. THE SUPERA; HOWEVER, WAS PULLED BACK INTO THE EXTERNAL ILIAC ARTERY. SHORTING OF THE STENT WAS NOTED AFTER THE NOSECONE WAS REMOVED. IT WAS NOTED THAT THE DEVICE INITIALLY WAS NOT REMOVED UNDER FLUOROSCOPY. THE DISTAL LESION WAS TREATED WITH A 5.0X40MM DRUG COATED BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18537301 ↗
• MalfunctionAug 1, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED FEMORAL-POPLITEAL ARTERY. THE LESION WAS PRE-DILATED WITH TWO NON-ABBOTT BALLOON 3X40MM AND 5X40MM. THE 5.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, IT WAS NOTED IT ONLY PARTIALLY DEPLOYED. THEREFORE, THE DEVICE WAS REMOVED. THE SUPERA 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 17436119 ↗
• MalfunctionApr 13, 2023Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation

  IT WAS REPORTED, THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT POPLITEAL ARTERY. THE LESION WAS PRE-DILATED WITH A 5.5 AND A 6.0MM NON-ABBOTT BALLOON. THE 5.5X40MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND DEPLOYMENT INITIATED. AFTER APPROXIMATELY 2/3 OF THE STENT WAS DEPLOYED, THE STENT COULD NOT BE FULLY DEPLOYED. THE THUMB SLIDE WAS ABLE TO TURN, BUT THE STENT WAS NOT DEPLOYING. TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING ROTATING THE HANDLE AND GENTLY PUSHING BACK AND FORTH. THE STENT WAS ABLE TO FULLY DEPLOY. HOWEVER, IT WAS NOTED IT ELONGATED APPROXIMATELY 1CM. THE STENT WAS DEPLOYED IN THE TARGET LESION WITH THE ELONGATED PART REACHING 1CM INTO THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE DELIVERY SYSTEM WAS NOT REMOVED UNDER FLUOROSCOPY. 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 16733842 ↗
• MalfunctionJan 7, 2022Difficult or Delayed Activation; Material Deformation; Difficult or Delayed Activation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A GREATER THAN 70% STENOSED VESSEL IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS ROUGHLY 5-6MM IN DIAMETER AND WAS PREPARED USING A BALLOON AT NOMINAL PRESSURES. ATHERECTOMY WAS NOT USED. THE COLLAGEN PLUG WAS DEPLOYED FOR A NON-ABBOTT CLOSURE DEVICE AND WAS CAUSING BLOCKAGE. THE 5.5X40MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE DEPLOYED TO TREAT THE BLOCKAGE; HOWEVER, AFTER A THIRD TO HALFWAY OF THE STENT WAS DEPLOYED THE PHYSICIAN DECIDED HE DIDN'T LIKE HOW THE NON-ABBOTT CLOSURE DEVICE WAS DEFORMING THE SUPERA STENT AND DECIDED IT WAS NOT SUITABLE AFTER TAKING ADDITIONAL PICTURES. THE PHYSICIAN REMOVED THE PARTIALLY DEPLOYED SUPERA STENT UNDER FLUOROSCOPY WITH NO ISSUES AND REPLACED WITH A COVERED STENT THAT COMPLETED THE 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 13196380 ↗
• MalfunctionJun 25, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED LESION IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 5.5X40 SUPERA STENT SYSTEM WAS ADVANCED TO THE LESION AND IMPLANTED WITHOUT ISSUE; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, RESISTANCE WAS FELT AND THE TIP SEPARATED BUT REMAINED AT THE HUB OF THE GUIDING SHEATH AND WAS EASILY REMOVED WITHOUT INTERVENTION. 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 12071151 ↗
• InjuryApr 2, 2021Stretched; Device Damaged by Another Device; Difficult to Advance; Material Deformation; Stretched; Device Damaged by Another Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS DE NOVO LEFT SUPERFICIAL FEMORAL ARTERY THAT WAS 50% STENOSED. VESSEL DIAMETER WAS 4.5MM, LESION LENGTH WAS 250MM. USING A CONTRALATERAL APPROACH FROM THE LEFT COMMON FEMORAL ARTERY, A NON-ABBOTT GUIDEWIRE WAS PLACED THEN A 5.0X20MM NON-ABBOTT BALLOON WAS USED TO DILATE A CALCIFIED NODULE AT 4ATM SEVERAL TIMES, THEN A 5.0X100MM NON-ABBOTT BALLOON WAS USED TO DILATE THE ENTIRE LESION AT 30ATM. THE 5.5X40 SUPERA STENT WAS IMPLANTED. THE STENT WAS TIGHT AT THE CALCIFIED NODULE. PART OF THE STENT WAS ELONGATED FOR A TOTAL LENGTH OF 50MM. A 4.0X40MM NON-ABBOTT BALLOON WAS ATTEMPTED TO BE DELIVERED TO A POPLITEAL LESION BUT RESISTANCE WAS FELT ADVANCING THROUGH THE IMPLANTED SUPERA STENT. THE DELIVERY WAS STOPPED, AND IT WAS THEN CONFIRMED BY FLUOROGRAPHY THAT THE SUPERA STENT HAD STRETCHED FOR AN APPROXIMATE TOTAL LENGTH OF 70MM. A NON-ABBOTT BALLOON WAS USED TO DILATE THE DISTAL AND PROXIMAL PART OF THE SUPERA STENT, THEN THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IN THE PHYSICIAN¿S OPINION, IT WAS POSSIBLE THAT THE BALLOON BECAME CAUGHT WITH THE TIGHT PART OF THE IMPLANTED SUPERA STENT. THERE

  Patient problems: Insufficient Information

  MAUDE report 11610678 ↗
• MalfunctionJan 26, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.5 X 40 MM SUPERA STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY WITHOUT DIFFICULTY AND STENT DEPLOYMENT WAS INITIATED; HOWEVER, BEFORE THE SYSTEM WAS LOCKED, THE STENT FULLY DEPLOYED IN THE TARGET LESION. NO ADDITIONAL INTERVENTION WAS REQUIRED DUE TO THE DEPLOYMENT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231003 ↗
• MalfunctionJan 14, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ARTERIOVENOUS FISTULA. A 5.5X40MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO A PREVIOUSLY DEPLOYED STENT. THE STENT WAS PARTIALLY DEPLOYED IN AN UNSPECIFIED INTRODUCER SHEATH, AND THE STENT WAS REMOVED WITH THE SHEATH AND DELIVERY SYSTEM. AN UNSPECIFIED SUPERA STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11171149 ↗
• MalfunctionOct 23, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED, AND A 5.5X150MM SUPERA SELF-EXPANDING STENT WAS IMPLANTED. THEN A 5.5X40MM SUPERA STENT WAS DEPLOYED, BUT THE STENT REMAINED IN THE INTRODUCER SHEATH AND WAS REMOVED. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 10727958 ↗
• MalfunctionOct 20, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 5.3MM VESSEL WAS PRE-DILATED WITH A 4.0X20MM NON-ABBOTT BALLOON CATHETER AT 18 ATMOSPHERES FOR THREE MINUTES. A 5.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE; HOWEVER, THE STENT DIDN¿T DEPLOY HALF-WAY. THE STENT AND SESS WERE REMOVED UNDER FLUOROSCOPY WITHOUT ISSUES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 10708523 ↗
• InjuryMay 19, 2020Difficult to Remove; Material Separation; Stretched; Difficult to Advance; Difficult to Remove; Material Separation; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2020, TO TREAT AN 80% STENOSED MODERATELY CALCIFIED LESION IN THE LEFT POPLITEAL ARTERY. LASER ATHERECTOMY AND BALLOON ANGIOPLASTY WERE PERFORMED TO PREPARE THE LESION. THE 5.5 X 40 MM SUPERA STENT DELIVERY SYSTEM WAS ADVANCED. SOME RESISTANCE WAS NOTED DURING ADVANCEMENT, DUE TO THE VESSEL ANATOMY; HOWEVER, THE DEVICE WAS ABLE TO BE PLACED AT THE TARGET LESION. DEPLOYMENT WAS INITIATED, AND IT WAS NOTED THAT THE DEVICE SEEMED TO BE "STACKING", ALTHOUGH THIS WAS NOT SEEN ON ANGIOGRAPHY. IT WAS FELT THAT THE STENT WAS DEPLOYED, SO REMOVAL OF THE STENT DELIVERY SYSTEM WAS INITIATED; HOWEVER, RESISTANCE WAS FELT AND THE STENT WAS NOTED TO BE PULLED BACK INTO THE POSTERIOR TIBIAL ARTERY AND ELONGATED. THE STENT DELIVERY SYSTEM WAS REMOVED, BUT IT WAS NOTED THAT THE NOSE CONE AND A PORTION OF THE DELIVERY SYSTEM REMAINED IN THE PATIENT ANATOMY, ON THE GUIDE WIRE. A GUIDE CATHETER WAS ADVANCED VIA CONTRALATERAL ACCESS AND THE SEPARATED SEGMENT WAS PUSHED INTO THE GUIDE CATHETER AND REMOVED. THE PATIENT WAS PLACED ON DUAL ANTI-PLATELET THERAPY OF ASPIRIN AND PLAVIX. ON (B)(6) 2020, ONE DAY POST PROCEDURE, THE PATIENT PRESENTED AT

  Patient problems: Claudication; Occlusion; Thrombosis

  MAUDE report 10072713 ↗
• MalfunctionApr 14, 2020Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY TORTUOUS, HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A NON-ABBOTT SHEATH WAS ADVANCED ALONG WITH A 5.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS). AFTER THE PHYSICIAN TOOK THEIR HAND OFF THE DEVICE, THE SESS MOVED 2-3CM BY ITSELF. THE SESS WAS ADVANCED TO THE TARGET LESION WHEN THE SESS MOVED IN THE SAME WAY AGAIN. THE SESS WAS ADVANCED, AND THE STENT WAS IMPLANTED SUCCESSFULLY. 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 9957204 ↗
• MalfunctionMar 12, 2020Stretched; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE RIGHT POPLITEAL ARTERY. THE 5.5X40MM SUPERA STENT ELONGATED DURING DEPLOYMENT. THE STENT REMAINS IN THE TARGET LESION. 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 9826498 ↗
• InjuryDec 17, 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 HEAVILY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. PEDAL ACCESS AND A SHOCK WAVE WERE USED PRIOR TO DEPLOYMENT. THE 6.0MM VESSEL WAS PRE-DILATED WITH AN UNSPECIFIED 5.5X60MM BALLOON CATHETER FOR 60 SECONDS AT NOMINAL PRESSURE. A 5.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITH NO PROBLEM. ALL STEPS WERE PERFORMED PER THE INSTRUCTIONS FOR USE DURING DEPLOYMENT; HOWEVER, IT WAS NOT VERIFIED UNDER FLUOROSCOPY THAT THE STENT HAD FULLY DEPLOYED AND THE SESS WAS REMOVED. THE CATHETER WAS PULLED BACK THROUGH THE SHEATH WITH THE STENT STILL IN THE SHEATH. AT SOME POINT, THE STENT DEPLOYED OFF THE DELIVERY CATHETER, BUT STILL IN THE SHEATH. THEN THE ANTERIOR TIBIAL ARTERY BECAME DISSECTED. A BALLOON CATHETER WAS ADVANCED TO SUCCESSFULLY REATTACH THE DISSECTION FLAP. THEN ALL THE DEVICES, INCLUDING THE SUPERA STENT, DELIVERY CATHETER AND SHEATH WERE REMOVED AS A SINGLE UNIT. A NEW UNSPECIFIED SUPERA STENT WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE PATIENT IS STABLE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITI

  Patient problems: Intimal Dissection

  MAUDE report 9477729 ↗