SUPERA S-60-060-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648211805), received between Jun 1, 2018 and Aug 29, 2025 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Material Separation; Mechanical Jam; Activation Failure; Material Separation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A POPLITEAL AND SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. AN UNSPECIFIED 5MM BALLOON WAS USED TO PREPARE THE VESSEL AT NOMINAL PRESSURE FOR 2 MINUTES. HALFWAY DURING THE DEPLOYMENT, THE 6.0X60MM SUPERA SELF-EXPANDING STENT WOULD NOT ADVANCE WHEN MOVING THE THUMBSLIDE. THE DEPLOYMENT LOCK AND STENT LOCK WERE BOTH IN THE OPEN POSITION WITH THE STENT PARTIALLY DEPLOYED, WHEN BOTH THE NOSE CONE AND SHAFT BROKE OFF IN THE PATIENT. THE NOSE CONE, PARTIALLY DEPLOYED STENT, AND SEPARATED PORTIONS WERE RETRIEVED FROM THE PATIENT ANATOMY VIA CUT DOWN WITH NOTHING REMAINING IN THE PATIENT. AN UNSPECIFIED STENT WAS USED 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 22925718 ↗
• InjuryJul 25, 2025Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE COMMON TEMPORAL ARTERY. THE 6.0X60MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER THE STENT WAS NOT COMPLETELY DEPLOYED FROM THE SES. DURING WITHDRAWAL OF THE SES, THE STENT DEPLOYED HOWEVER THE TIP OF THE SES SEPARATED. A SNARE DEVICE WAS USED TO REMOVE IT. 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 22611833 ↗
• MalfunctionJul 14, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THE 6.0X60MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT ONLY PARTIALLY DEPLOYED. THE SES WITH THE STENT WAS REMOVED FROM THE PATIENT. 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 22494619 ↗
• MalfunctionAug 3, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE ADVANCED ONTO THE STEELCORE 18 GUIDE WIRE WHEN THE STENT SYSTEM GOT STUCK AND SHEARED THE GUIDE WIRE CAUSING THE GUIDE WIRE TO PEEL. THE DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WAS NOTHING LEFT IN THE PATIENT. ANOTHER STEELCORE GUIDE WIRE AND SUPERA STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453953 ↗
• InjuryMar 21, 2023Material Separation; Activation Failure; Material Separation; Activation Failure

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: PRE-DILATATION WAS PERFORMED WITH A 6X40MM BALLOON PRIOR TO USE OF THE SUPERA. A 6F, 10CM NON-ABBOTT SHEATH WAS USED. FLUOROSCOPY WAS USED DURING DEPLOYMENT AND REMOVAL OF THE SUPERA DEVICE. A 7.0X40MM NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588015 ↗
• MalfunctionFeb 28, 2023Material Separation; Stretched; Activation Failure; Material Separation; Stretched; Activation Failure

  IT WAS REPORTED THAT THE 6.0X60MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS PREPARED PER THE INSTRUCTION FOR USE (IFU). THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 60% STENOSED LESION IN THE RIGHT COMMON ILIAC ARTERY. THE DEVICE WAS ADVANCED TO THE LESION THROUGH A NON-ABBOTT SHEATH. DURING DEPLOYMENT, THE SUPERA STENT WAS BECOMING STRETCHED, SO TROUBLE SHOOTING WAS PERFORMED TO MAKE SURE THE DEVICE WAS FULLY UNLOCKED, AND IT WAS, HOWEVER THE STENT CONTINUED TO STRETCH AND THEN SNAPPED BACK INTO THE NON-ABBOTT SHEATH WITH PART OF THE STENT HANGING OUT OF THE SHEATH, IN THE ILIAC ARTERY. THE PHYSICIAN PULLED BACK ON THE DELIVERY CATHETER TO REMOVE THE DEVICE AND THE NOSE CONE SEPARATED IN THE NON-ABBOTT SHEATH WHERE IT REMAINED. THE DEVICES WERE ALL REMOVED AS A SINGLE UNIT SO THAT NOTHING REMAINED IN THE ANATOMY, AND IMAGING CONFIRMED THAT NOTHING REMAINED IN THE ANATOMY. IT WAS DECIDED TO ABORT THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457028 ↗
• MalfunctionNov 28, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT POPLITEAL ARTERY. THE VESSEL DIAMETER WAS 6.00MM AND THE VESSEL WAS PREPPED WITH A 6.00X120MM BALLOON FOR 2 MINUTES AT 10 ATMOSPHERES (ATM). A 6.00X55CM SHEATH AND A 18 COMMAND ST GUIDEWIRE WERE USED. THE 6.00X60MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT APPEARED TO HAVE DIFFICULTY DEPLOYING. THE THUMB SLIDE MOVED WITHOUT RESISTANCE. THE PHYSICIAN CONTINUED TO ADVANCED THE THUMBSLIDE AND THE STENT EVENTUALLY DEPLOYED WITHOUT FURTHER ISSUE. THE STENT WAS CONFIRMED TO BE FULLY OPPOSED TO THE VESSEL WALL AND THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. 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 15874376 ↗
• InjuryJun 7, 2022Break; Stretched; Material Deformation; Break; Stretched; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, DURING DEPLOYMENT, THE STENT WAS NOTED TO BE BUNCHED, MANGLED, AND POSSIBLY FRACTURED. DUE TO VESSEL RECOIL, THE STENT ELONGATED. A NON-ABBOTT COVERED STENT WAS IMPLANTED OVER THE SUPERA STENT, TO TREAT THE STENT IRREGULARITY. THE PATIENT HAD A GOOD OUTCOME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vasoconstriction

  MAUDE report 14627403 ↗
• MalfunctionJan 26, 2022Difficult to Remove; Difficult to Advance; Activation Failure; Difficult to Remove; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT COMMON FEMORAL ARTERY. DURING ADVANCEMENT THE 6.0X60MM SUPERA SELF-EXPANDING STENT (SESS) MET RESISTANCE WITH THE SHEATH. THE SESS WAS UNABLE TO BE DEPLOYED AND WAS REMOVED. IT WAS ALSO NOTED DURING REMOVAL THE SESS MET RESISTANCE WITH THE SHEATH. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358702 ↗
• InjuryJan 10, 2022Material Separation; Difficult or Delayed Activation; Material Deformation; Material Separation; Difficult or Delayed Activation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE RIGHT COMMON FEMORAL ARTERY. THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION, AND AN ATTEMPT WAS MADE TO DEPLOY STENT IN THE RIGHT COMMON FEMORAL ARTERY; HOWEVER, THE STENT WOULD NOT RELEASE. THE PHYSICIAN FINALLY WAS ABLE TO GET THE STENT TO RELEASE; HOWEVER, THE PROXIMAL END TWISTED ABOUT 180 DEGREES. TWO NON-ABBOTT STENTS WERE THEN DEPLOYED, WITH ONE OF THE STENTS IMPLANTED OVERLAPPING THE SUPERA, TO FULLY EXPAND THE STENT AT THE LOCATION IT WAS TWISTED. DURING REMOVAL OF THE DELIVERY SYSTEM, THE PHYSICIAN WAS AGGRESSIVE AND THE DELIVERY CATHETER SEPARATED. ALL PORTIONS OF THE DEVICE WERE ABLE TO BE REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. 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 13211805 ↗
• InjuryOct 20, 2021Adverse 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 LESION IN THE LEFT POPLITEAL ARTERY. THE PATIENT PRESENTED WITH A THROMBOSED AND FRACTURED PREVIOUSLY IMPLANTED NON-ABBOTT STENT. A 6X60MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS ADVANCED AND DEPLOYED WITHOUT ISSUE. ONE-HOUR POST-PROCEDURE, WHILE THE PATIENT WAS IN RECOVERY, THE PATIENT EXPERIENCED PAIN IN THE LEFT LEG AND A THROMBUS WAS NOTED AT THE IMPLANTED SUPERA STENT. THE PATIENT WAS THEN TAKEN FOR BYPASS SURGERY. THE BYPASS SURGERY WAS SUCCESSFUL, AND THE PATIENT REMAINED AN EXTRA NIGHT IN THE HOSPITAL FOR OBSERVATION. 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; Thrombosis/Thrombus

  MAUDE report 12669481 ↗
• MalfunctionMar 10, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT THE DISTAL LEFT SUPERIOR FEMORAL ARTERY. A 6.0X60 SUPERA STENT WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, DURING ADVANCEMENT, THE STENT INTERACTED WITH A PREVIOUSLY IMPLANTED STENT, CAUSING THE STENT TO ELONGATE ROUGHLY 20MM. THE STENT WAS STILL ABLE TO BE DEPLOYED AT THE TARGET LESION WITHOUT ISSUES. NO ADVERSE PATIENT EFFECTS OCCURRED 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 11455635 ↗
• MalfunctionFeb 26, 2021Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERIOR FEMORAL ARTERY (SFA). A 6X60MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. DEPLOYMENT WAS PERFORMED BUT WAS NOT VIEWED UNDER FLUOROSCOPY. THE DEVICE WAS LOCKED AND DURING REMOVAL, RESISTANCE WAS NOTED. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE STENT WAS STRETCHED AND DID NOT RELEASE FROM THE DELIVERY SYSTEM. AT THAT POINT, THE DEVICE WAS UNLOCKED, THE STENT RELEASED AND IMPLANTED, AND THE DELIVERY SYSTEM REMOVED. AN ABSOLUTE PRO STENT WAS THEN DEPLOYED INSIDE THE STRETCHED SUPERA STENT TO ENSURE A PROPER FIT AND TO HELP SUPPORT THE STRETCHED STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11388024 ↗
• MalfunctionDec 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED THROUGH THE INTRODUCER SHEATH WHEN THE DECISION WAS MADE NOT TO DEPLOY THE STENT. DURING RETRACTION IT WAS NOTED THE NOSECONE SEPARATED FROM THE SESS. THE SESS AND SHEATH WERE RETRACTED AS A UNIT AND THE PROCEDURE COMPLETED AT THIS TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11013602 ↗
• InjuryNov 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL ARTERY. A 6X60MM SUPERA SELF-EXPANDING STENT WAS IMPLANTED ON (B)(6) 2017 WITHOUT ISSUES. ON (B)(6) 2018, RESTENOSIS WAS NOTED IN THE STENT, SO AN UNSPECIFIED BALLOON WAS USED AS TREATMENT. ON (B)(6) 2020, RESTENOSIS WAS NOTED, AND THE STENT HAD FRACTURED INTO TWO PIECES. AN UNSPECIFIED BALLOON AND A 7X60MM NON-ABBOTT STENT WERE USED AS TREATMENT, AND THE PATIENT IS FINE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 10771427 ↗
• MalfunctionSep 9, 2020Stretched; Defective Device; Stretched; Defective Device

  IT WAS REPORTED THAT THE 6.0X60 MM SUPERA STENT WAS BEING DEPLOYED IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WHEN THE DOCTOR THOUGHT IT WAS TAKING A LONG TIME TO DEPLOY THE STENT. AT ONE POINT, THE DOCTOR THOUGHT THE STENT WAS FULLY DEPLOYED SO HE RETRACTED THE DELIVERY SYSTEM AND NOTICED THAT THERE WAS STILL STENT REMAINING TO BE DEPLOYED. THIS STRETCHED THE STENT OUT A LITTLE BIT, WITHIN 10% OF ITS LABELED LENGTH. AFTER THE STENT WAS FULLY DEPLOYED, THE DOCTOR THOUGHT THE DEPLOYED LENGTH WAS 150 MM INSTEAD OF THE LABELED 60 MM. THE EXTRA STENT LENGTH WAS DEPLOYED IN THE SFA THAT THE DOCTOR DID NOT INTEND TO TREAT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511257 ↗
• MalfunctionDec 17, 2019Product Quality Problem; Tear, Rip or Hole in Device Packaging; Product Quality Problem; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TYVEK POUCH ON A 6.0X60MM SUPERA SELF-EXPANDING STENT SYSTEM SEPARATED TOO QUICKLY DURING OPENING AND CAUSED THE PRODUCT TO FALL. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 6.0X60MM SUPERA STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS IDENTIFIED THAT THE TYVEK POUCH WAS TORN FROM THE UPPER LEFT-HAND SIDE DOWN TO THE BOTTOM RIGHT HAND SIDE.

  Patient problems: No Patient Involvement

  MAUDE report 9481447 ↗
• MalfunctionDec 11, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT COMMON FEMORAL ARTERY. DURING DEPLOYMENT OF THE 6.0X60 MM SUPERA SELF EXPANDING STENT (SES), THE STENT JUMPED AND DEPLOYED INTO THE SHEATH. THE STENT WAS REMOVED FROM THE PATIENT INSIDE THE SHEATH AS IT WAS NOT OPPOSED TO THE VESSEL WALL ON THE DISTAL END. ANOTHER SHEATH AND SUPERA SELF EXPANDING STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451543 ↗
• MalfunctionAug 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER SUPERA STENT DEPLOYMENT IN THE LESION, THE NOSE CONE WAS NOTED TO BE DETACHED, BUT REMAINED ON THE GUIDE WIRE. THE WIRE WITH THE NOSE CONE WAS SIMPLY REMOVED WITHOUT ISSUE AND THE CASE WAS SUCCESSFULLY COMPLETED AFTER RE-WIRING. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857965 ↗
• MalfunctionFeb 14, 2019Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, NON-CALCIFIED EXTERNAL ILIAC ARTERY. A 60X120MM SUPERA SELF-EXPANDING STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED AT THE LESION SUCCESSFULLY, WITH NO RESISTANCE NOTED. HOWEVER, THE PHYSICIAN DID NOT LOCK BOTH LEVERS BEFORE REMOVAL. THE DELIVERY SYSTEM WAS REMOVED WITH NO RESISTANCE. IT WAS THEN ATTEMPTED TO ADVANCE AN UNSPECIFIED BALLOON DILATATION CATHETER THROUGH THE SHEATH, BUT COULD NOT. FLUOROSCOPY WAS DONE AND SHOWED THAT THE WHITE TIP OF THE SUPERA BROKE OFF AND REMAINED IN THE SHEATH. THE SHEATH UNIT WAS SIMPLY REMOVED TO RETRIEVE THE BROKEN TIP PORTION. 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 8339886 ↗
• InjuryJun 1, 2018Detachment Of Device Component; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE LEFT SUPERFICIAL FEMORAL ARTERY, THE 4.5 X 100 MM SUPERA STENT WAS IMPLANTED, WITHOUT ISSUE. DURING DELIVERY SYSTEM REMOVAL, THE THUMBWHEEL WAS NOT LOCKED AND RESISTANCE WAS NOTED. THE TIP DETACHED AND TRAVELED DISTALLY INTO THE POPLITEAL ARTERY, BUT WAS RETRIEVED USING A NON-ABBOTT SNARE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7563337 ↗