SUPERA S-60-040-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648211799), received between Oct 14, 2016 and Feb 10, 2026 — classified as 7 injuries, 11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Stretched; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS PRE-DILATED WITH A 6MM NON-COMPLIANT BALLOON. THE 6.0X40MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT SIGNIFICANT ELONGATION OCCURRED AFTER THE START OF DEPLOYMENT; THEREFORE, DEPLOYMENT WAS ABORTED. THE SES WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. REPEAT IVUS IMAGING SHOWED SIGNIFICANT RECOIL, WITH THE LUMEN MEASURING APPROXIMATELY 5.3 MM. PER THE PHYSICIAN, THE SUPERA STENT DID NOT CAUSE OR CONTRIBUTE TO THE VESSEL RECOIL. BALLOON ANGIOPLASTY WAS PERFORMED AGAIN FOLLOWED BY DEPLOYMENT OF ANOTHER SUPERA STENT. GOOD FLOW WAS OBTAINED, AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY. PER THE PHYSICIAN THE ELONGATION WAS CONSIDERED LIKELY DUE TO GREATER THAN EXPECTED VESSEL RECOIL, RESULTING IN INADEQUATE LUMINAL EXPANSION DURING INITIAL PREPARATION. 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 24303087 ↗
• MalfunctionNov 19, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH A VESSEL DIAMETER OF 6.5MM. AFTER THE LESION WAS PREPARED WITH A 7MM DILATATION BALLOON TO 10 ATMOSPHERES, A 6X40MM SUPERA SELF-EXPANDING STENT (SES) WAS ATTEMPTED TO BE DEPLOYED AT THE LESION; HOWEVER, IT WAS NOTED THAT THE STENT ONLY PARTIALLY DEPLOYED. THE SES WAS REMOVED AND ANOTHER SAME SIZED SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723882 ↗
• InjuryMay 5, 2023Material Separation; Improper or Incorrect Procedure or Method; Activation Failure; Material Separation; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN AN UNSPECIFIED ARTERY. THE 6.0X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION, HOWEVER, THE DELIVERY SYSTEM WAS REMOVED FROM THE ANATOMY BEFORE DEPLOYMENT OF THE STENT AND IT WAS NOTED THAT THE CATHETER TIP WAS SEPARATED. THE TIP WAS REMOVED FROM THE ANATOMY. A 5.0X40MM SUPERA STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED MDR, THE FOLLOWING INFORMATION WAS PROVIDED: THE PROCEDURE WAS TO TREAT THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) TO POPLITEAL ARTERY WITH 90-99% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE VESSEL DIAMETER WAS 6MM AND THE VESSEL WAS PREPARED USING A NON-ABBOTT BALLOON. ATHERECTOMY WAS NOT USED. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE DEVICE WAS PARTIALLY DEPLOYED. THERE WERE NO ISSUES WITH THE DEPLOYMENT MECHANISM. THE PHYSICIAN DID NOT ROTATE THE SYSTEM LOCK AND THE DEPLOYMENT LOCK INTO THE LOCKED POSITION (IN LINE WITH THE THUMB SLIDE). THE THUMB SLIDE WAS NOT FULLY RETRACTED TO THE START POSITION AND BOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877041 ↗
• InjuryApr 21, 2023Off-Label Use; Difficult to Advance; Off-Label Use; Difficult to Advance

  IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE PROCEDURE WAS PERFORMED TO TREAT AN OCCLUSION IN AN ARTERIOVENOUS GRAFT (AVG) OF A TORTUOUS PART OF THE ELBOW. A KINK WAS NOTED IN THE PREVIOUS UNSPECIFIED IMPLANTED STENT. THE SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED, AND THE STENT WAS DEPLOYED. THE ARTIFICIAL DIALYSIS WAS DRAINED WHICH CAUSED A DROP IN BLOOD PRESSURE. THIS RESULTED IN ACUTE OCCLUSION. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED AND THE PATIENT RECOVERED. IT WAS NOTED THAT PLACEMENT OF THE SUPERA STENT IS SOMEWHAT DIFFICULT TO POSITION DUE TO THE RESILIENCE OF THE STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 16786388 ↗
• MalfunctionSep 13, 2022Difficult to Remove; Patient-Device Incompatibility; Difficult to Remove; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE 6.0X40 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION IN THE POPLITEAL ARTERY WITH NO NOTE OF CALCIFICATION OR TORTUOSITY. UPON THE START OF DEPLOYMENT THE PHYSICIAN NOTED THE STENT WAS NOT APPOSED TO THE VESSEL WALL AS IT WAS UNDERSIZED FOR THE SIZE OF THE VESSEL. THEREFORE, THE SESS WAS REMOVED AND DURING REMOVAL IT CAUGHT ON THE 6FR 45CM NON-ABBOTT SHEATH. THE SHEATH AND THE SUPERA SESS WERE REMOVED TOGETHER AS A UNIT. THE LESION WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH A 9X40 ABSOLUTE PRO SESS. 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 15412874 ↗
• InjuryAug 2, 2022Device Damaged by Another Device; Migration; Device Damaged by Another Device; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SUPERA SELF EXPANDING STENT WAS IMPLANTED IN THE COMMON FEMORAL ARTERY. ON (B)(6) 2022 AN ANGIOGRAPHY WAS PERFORMED AND THE SHEATH THAT WAS INSERTED INTERACTED WITH THE SUPERA STENT, CAUSING IT TO MIGRATE UPWARD AND NOW, NO PORTION OF THE SUPERA REMAINS IN THE TARGET LESION. A NON- ABBOTT STENT WAS USED TO EMBED THE SUPERA IN PLACE SO IT WILL NOT MIGRATE AGAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15146867 ↗
• MalfunctionDec 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE SUPERA SELF-EXPANDING STENT (SES), THE NOSECONE CAME OFF THE DEVICE. THERE WAS NO FORCED MANIPULATION, IT JUST EASILY CAME OFF. THEREFORE, THE DEVICE WAS EXCHANGED FOR A NEW SUPERA. 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 13098136 ↗
• MalfunctionJun 28, 2021Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED, 80% STENOSED COMMON FEMORAL ARTERY. AN UNSPECIFIED ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS USED FOR PRE-DILATATION WITHOUT ISSUE. A 6X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE, AND THE STENT WAS DEPLOYED. HOWEVER, THE NOSE CONE TIP FACED RESISTANCE WITH THE NOW IMPLANTED STENT DURING REMOVAL, WHICH STRETCHED THE STENT LESS THAN 10%. THE SESS WAS REMOVED WITHOUT FURTHER ISSUE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12076628 ↗
• MalfunctionMar 31, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE LEFT SUPERFICIAL FEMORAL ARTERY, HEAVILY CALCIFIED LESION.A SUPERA STENT WAS SUCCESSFULLY IMPLANTED. A SECOND SUPERA STENT (S-60-040-120-P6, 0050461) WAS ALSO DEPLOYED SUCCESSFULLY. WHILE REMOVING THE SECOND SUPERA DELIVERY SYSTEM HOWEVER, RESISTANCE WAS MET BETWEEN THE SECOND SUPERA DELIVERY SYSTEM AND THE STEELCORE GUIDE WIRE (1007710-J, 0080761). THE GUIDE WIRE AND SUPERA DELIVERY SYSTEM WERE REMOVED WITHOUT FURTHER ISSUES AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT, NO INTERVENTION OR TREATMENT REQUIRED, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11599753 ↗
• InjuryFeb 23, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS 6MM, A 6MM X 40MM SHEATH WAS USED. AN UNSPECIFIED STENT WAS IMPLANTED, AND THE 6.0X40MMX120CM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED, TO BE IMPLANTED NEXT TO THE PREVIOUSLY IMPLANTED STENT. THE SUPERA STENT WAS DIFFICULT TO DEPLOY. THE STENT EVENTUALLY RELEASED USING MANIPULATIONS ON THE THUMBSLIDE. DURING DEPLOYMENT, THE STENT MOVED FROM ITS INTENDED LOCATION AND DID NOT COVER THE TARGET LESION. THE SUPERA ENDED UP INSIDE OF THE PREVIOUSLY PLACED STENT, INSTEAD OF CONNECTING AND EXTENDING THE PREVIOUSLY PLACED STENT. THEREFORE, ANOTHER STENT HAD TO BE IMPLANTED TO COVER THE LESION. 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 11366428 ↗
• InjuryDec 17, 2020Stretched; Activation Failure; Migration; Stretched; Activation Failure; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT EXTERNAL ILIAC THAT WAS HEAVILY CALCIFIED. A SUPERA 5.5 WAS DEPLOYED WITHOUT ISSUE. A SECOND SUPERA WAS ADVANCED TO THE LESION AND DEPLOYED, BUT DURING REMOVAL OF THE STENT DELIVERY SYSTEM, THE STENT WAS DRAGGED AND STRETCHED OVER THE BIFURCATION, RESULTING IN NO BLOOD FLOW OR PULSES TO THE LOWER EXTREMITY. TWO STENTS WERE IMPLANTED AS TREATMENT TO OPEN THE VESSELS. ON (B)(6) 2020, SURGICAL BYPASS WAS SUCCESSFULLY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 11032520 ↗
• MalfunctionSep 18, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100%, HEAVILY CALCIFIED AND CHRONIC TOTALLY OCCLUDED (CTO), LESION. THE VESSEL DIAMETER WAS 6.0MM AND THE LESION LENGTH WAS 100MM. A 6F 45CM SHEATH WAS ADVANCED AND THE LESION WAS PRE-DILATATION WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. A 6.0X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS TO BE IMPLANTED AT THE DISTAL PART OF THE LESION AND A NON-ABBOTT STENT AT THE PROXIMAL PART OF THE LESION. THE SESS WAS ADVANCED AND ON ATTEMPTING TO DEPLOY THE STENT, THE USER INADVERTENTLY PULLED THE SESS BACK AFTER 1CM HAD DEPLOYED AND THE STENT JUMPED. THE SUPERA SESS WAS REMOVED UNDER FLUOROSCOPY WITH THE STENT PARTIALLY DEPLOYED. THE NON-ABBOTT STENT WAS IMPLANTED AT THE PROXIMAL TO DISTAL PART OF LESION WERE THE SUPERA WAS PLANNED TO BE IMPLANTED, SUCCESSFULLY COMPLETING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10554644 ↗
• MalfunctionMar 12, 2020Difficult to Remove; Material Separation; Activation Failure; Difficult to Remove; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, NONE TORTUOUS DE NOVO COMMON FEMORAL ARTERY THAT WAS 90% STENOSED. THE 6.0X40MM SUPERA STENT DELIVERY SYSTEM WAS ADVANCED WITH A 6F NON-ABBOTT GUIDING CATHETER. DURING DEPLOYMENT, THE PHYSICIAN BELIEVED THE ENTIRE LENGTH OF THE STENT HAD BEEN DEPLOYED. HEAVY RESISTANCE WAS NOTED DURING RETRIEVAL OF THE DELIVERY CATHETER AS THE STENT AND TIP WERE TRAPPED IN THE DELIVERY CATHETER AND SUBSEQUENTLY, THE TIP SEPARATED. THE REMAINING PROXIMAL END OF THE STENT WAS DEPLOYED IN THE GUIDING CATHETER. THE PHYSICIAN ATTEMPTED TO EXTRUDE THE STENT FROM THE GUIDING CATHETER BUT WAS UNSUCCESSFUL. THE GUIDING CATHETER WAS THEN DRAGGED IN AN ATTEMPT TO RELEASE THE STENT BUT WAS UNSUCCESSFUL. THE SHEATH, STENT AND SEPARATED TIP WERE REMOVED TOGETHER AS A SINGLE UNIT LEAVING THE GUIDEWIRE IN PLACE. A NEW 6.5X40MM SUPERA STENT WAS THEN IMPLANTED USING THE SAME GUIDING CATHETER. 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 9826549 ↗
• InjuryJan 29, 2020Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT DURING A MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY INTERVENTION, VISIBILITY WAS POOR, BUT IT WAS FELT THAT THE SUPERA STENT WAS DEPLOYED WITHOUT ISSUE; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, RESISTANCE WAS FELT. THE STENT ELONGATED BY ABOUT 40% AND THE NOSE CONE DETACHED. THE NOSE CONE WAS PULLED INTO THE SHEATH WITH THE USE OF BALLOONS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9645232 ↗
• MalfunctionDec 5, 2019Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking; Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, NON-TORTUOUS, 50% STENOSED MID RIGHT SUPERFICIAL FEMORAL ARTERY. A NON-ABBOTT ATHERECTOMY DEVICE WAS USED, AND THE LESION WAS DILATED WITH A 6X40MM NON-ABBOTT BALLOON AT 20 ATMOSPHERES FOR 120 SECONDS. A 6X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED USING A 6F 10CM SHEATH. THE DEPLOYMENT LOCK WAS UNLOCKED, AND RESISTANCE WAS FELT PUSHING THE THUMB SLIDE. THE STENT DID NOT FULLY DEPLOY, SO THE THUMB SLIDE WAS SLID UP AND DOWN TO NO AVAIL. DURING REMOVAL OF THE SESS, THE STENT WAS RELEASED AND THE DEPLOYED SUCCESSFULLY. THE STENT ELONGATED FOR 10MM. 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 9415456 ↗
• MalfunctionNov 8, 2019Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATATION WAS PERFORMED AND THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND DEPLOYMENT WAS INITIATED; HOWEVER, IT WAS NOTED THAT THE THUMBSLIDE LOCKED UP AND COULD NOT BE PUSHED FORWARD OR PULLED BACK. THE DEVICE, INCLUDING THE STENT, WAS REMOVED WITHOUT ADVERSE PATIENT EFFECT. ADDITIONAL DILATATION WAS PERFORMED, AND A SECOND SUPERA STENT WAS DEPLOYED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9301578 ↗
• MalfunctionAug 20, 2019Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED DISTAL FEMORAL ARTERY THAT HAD 100% RESTENOSED. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED ST. JUDE BALLOON DILATATION CATHETER (BDC) AND A 6.0X40MM NON-ABBOTT BDC. A 6.0X40MM SUPERA STENT WAS PLACED IN THE RESTENOSED SITE OF THE LESION. DURING POST-DILATATION, THE TIP OF THE NON-ABBOTT BDC PUSHED THE STRUT OF THE SUPERA AND THE SUPERA IMPLANT SLIPPED/MIGRATED DISTALLY INTO HEALTHY TISSUE PARTIALLY STILL REMAINING WITHIN THE TARGET LESION. AN ADDITIONAL 6.5X40MM SUPERA STENT WAS IMPLANTED TO COVER THE PROXIMAL PORTION. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8913250 ↗
• InjuryOct 14, 2016Detachment Of Device Component; Positioning Failure; Material Deformation

  SUBSEQUENT TO THE INITIAL 30-DAY MEDICAL DEVICE REPORT, A VOLUNTARY REPORT WAS RECEIVED WHICH STATES: PATIENT HAD PERIPHERAL VASCULAR DISEASE WITH CLAUDICATION OF THE LOWER EXTREMITY. DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE NOSE CONE [TIP] OF THE STENT BROKE OFF. CONSULT DONE WITH VASCULAR SURGEON, WHO RECOMMENDED AN ENDOVASCULAR PROCEDURE TO REMOVE THE RETAINED BROKEN PIECE OF STENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PTA OF RIGHT SUPERFICIAL FEMORAL ARTERY DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSE TO DO.

  Patient problems: Foreign Body In Patient

  MAUDE report 6031146 ↗