SUPERA S-55-120-120-P6 (UDI 08717648226144)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648226144), received between Aug 1, 2018 and Aug 18, 2026 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (11 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.

• MalfunctionAug 18, 2026Stretched; Difficult to Advance; Activation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307531 ↗
• MalfunctionJun 16, 2026Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY LESION. THE 5.5X150 MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE TARGET LESION AND FULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE SES, ELONGATION OCCURRED AND THE STENT WAS REMOVED. THIS ALSO OCCURRED WITH THE SECOND 5.5X150 MM SUPERA SES AND THE THIRD 5.5X120 MM SUPERA SES. A FOURTH 5.5X150 MM SUPERA SES AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524240 ↗
• MalfunctionMar 24, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED POPLITEAL ARTERY LESION. A 5.5 X 120 MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. HOWEVER, THE STENT CAME OUT OF THE PATIENT ANATOMY WITH THE DELIVERY SYSTEM DURING REMOVAL. AN ADDITIONAL SUPERA SES WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA 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 24681315 ↗
• MalfunctionFeb 25, 2026Stretched; Migration

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MILDLY TORTUOUS AND 70% STENOSED RIGHT SUPERIOR FEMORAL ARTERY. A SUPERA 5.5X120 WAS INSERTED AND DEPLOYED. HOWEVER, AFTER DEPLOYMENT, IT WAS OBSERVED THE STENT ELONGATED AND MIGRATED FROM ITS ORIGINAL LOCATION. NO ADDITIONAL TREATMENT WAS PERFORMED. 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 24448629 ↗
• MalfunctionJan 21, 2026Difficult to Remove; Material Separation; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE SFA WAS PREPPED AND BALLOONED WITH 1.25 MICRO DIAMONDBACK OAS AND A BARD DRUG COATED BALLOON. AFTER POST ANGIOGRAMS OF THE TREATMENT WERE TAKEN OF THE VESSEL THE PHYSICIAN DECIDED THE STENT THE PROXIMAL TAKE OFF THE SFA. A 5.50X120MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED OVER THE 0.014 VIPERWIRE TO THE PROXIMAL SFA AND DEPLOYMENT INITIATED. CAREFULLY DEPLOYING THE STENT THE PHYSICIAN NOTICED THAT THE STENT WAS GOING TO LAND PAST THE DESIRED LANDING POINT IN THE SFA. THE STENT WAS DEPLOYED PAST THE PROXIMAL SFA AND EXTENDED INTO THE COMMON FEMORAL ARTERY, JAILING OFF THE PROFUNDA ARTERY. AT THIS POINT THERE WAS STILL STENT LEFT TO BE DEPLOYED. THE PHYSICIAN DECIDED TO PULL OUT THE STENT THEREFORE THE SYSTEM WAS WALKED OUT OVER THE WIRE INTO THE SHEATH. UNDER FLUOROSCOPY THE STENT SYSTEM WITH THE PARTIALLY DEPLOYED STENT WAS COMING OUT; HOWEVER IT WAS NOTED THE DISTAL TAPERED TIP OF THE STENT WAS SEPARATED AND STUCK IN THE DISTAL SEGMENT OF THE 6FR. X 45CM SHEATH. THE PHYSICIAN THEN PROCEEDED TO WALK THE SHEATH WITH THE DISTAL TIP AND PARTIALLY DEPLOYED STENT IN IT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129489 ↗
• MalfunctionJan 12, 2026Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY, APPROXIMATELY 50% STENOSED. THE 5.5X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. DURING DEPLOYMENT, RESISTANCE WAS NOTED WITH THE ANATOMY. THE STENT PARTIALLY DEPLOYED AND WHEN THE SESS WAS PULLED BACK, THE STENT ELONGATED. THE SESS WAS REMOVED WITH THE STENT AND AN UNSPECIFIED 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 24045555 ↗
• MalfunctionMar 5, 2024Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION, MILD TORTUOSITY AND 95% STENOSIS. THE 5.5X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION ON A 0.018 ABBOTT GUIDE WIRE. THE SYSTEM LOCK WAS OPENED AND THE THUMB SLIDE WAS ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE WITH NO RESISTANCE NOTED; HOWEVER, THE STENT WAS ONLY PARTIALLY DEPLOYED WITH REPEATED PUSHING OF THE THUMB SLIDE. THE SESS WAS RETRACTED BACK TO THE SHEATH UNDER FLUOROSCOPY TO THE INTRODUCER TO CONFIRM THE STENT DID NOT FULLY DEPLOY. ANOTHER SAME SIZE SUPERA SESS COMPLETED 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 18841415 ↗
• MalfunctionApr 17, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION. THE 5.5X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS DEPLOYED; HOWEVER, WHEN THE CATHETER WAS BEING REMOVED, THE STENT REMAINED IN THE CATHETER AND BOTH WERE REMOVED TOGETHER. ANOTHER STENT 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 16754963 ↗
• MalfunctionMay 25, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED DE NOVO SUPERFICIAL FEMORAL ARTERY. THE LESION WAS PRE-DILATED WITH AN 6X80MM NON-ABBOTT BALLOON ONCE AT 12 ATMOSPHERES FOR 60 SECONDS. VIA CONTRALATERAL APPROACH, A 5.5X120MM SUPERA STENT WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND WAS ATTEMPTED TO DEPLOY. HOWEVER, THE STENT DEPLOYED ONLY PARTIALLY (APPROXIMATELY 5CM), THUS IT FAILED TO BE FULLY RELEASED. THE SUPERA WAS SIMPLY WITHDRAWN UNDER FLUOROSCOPY AND A NEW SAME SIZE SUPERA STENT WAS DEPLOYED WITHOUT 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 14493243 ↗
• MalfunctionDec 16, 2021Material Separation; Stretched; Activation Failure; Material Separation; Stretched; Activation Failure

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED POSTERIOR SUPERFICIAL FEMORAL ARTERY. IT WAS NOTED THAT IMAGING WAS VERY CHALLENGING, AND THE VESSEL WAS NOT PREPPED PRIOR TO INSERTING THE SUPERA 5.5X120. THE SUPERA WAS ABLE TO REACH THE TARGET LESION AND WAS ATTEMPTED TO BE DEPLOYED. HOWEVER, DURING DEPLOYMENT, IT WAS OBSERVED THE STENT STARTED TO ELONGATE INTO THE BIFURCATION OF THE FEMORAL ARTERY. THE NOSE CODE THEN BECAME CAUGHT ON THE SHEATH, BUT DUE TO CHALLENGING IMAGING, THE PHYSICIAN WAS UNABLE TO SEE THIS ISSUE. THE DEPLOYMENT SEQUENCE WAS CONTINUED, BUT IT WAS OBSERVED THE NOSE CODE DETACHED AND MIGRATED TO THE BIFURCATION. ALTHOUGH THE NOSE CODE DETACHED, IT BECAME STUCK ON THE SHEATH AND WAS NO LONGER MOBILE. SINCE THE STENT WAS NOT DEPLOYED, THE PHYSICIAN WAS ABLE TO REMOVE THE STENT DELIVERY SYSTEM AND THE SHEATH. ALL DEVICES WERE REMOVED FROM THE ANATOMY AND THE PHYSICIAN REPLACED THE SUPERA WITH A NON-ABBOTT DEVICE. ONCE REMOVED, IT WAS OBSERVED THE STENT WAS PARTIALLY DEPLOYED IN THE SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018392 ↗
• InjuryJun 14, 2021Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED RIGHT POPLITEAL ARTERY. THE VESSEL WAS PREPPED WITH TWO UNSPECIFIED BALLOONS (6.0X40MM AND 6X200MM). THE 5.5X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS DEPLOYED WITHOUT ISSUE; HOWEVER, THE USER INADVERTENTLY DID NOT RETRACT THE NOSECONE AND LOCKED IT. THEREFORE, WHEN THE DELIVERY SYSTEM WAS RETRACTED UNDER FLUOROSCOPY, THE STENT WAS PULLED BACK INTO THE SHEATH AND THE NOSE CONE BECAME DETACHED CAUSING A SIGNIFICANT DELAY IN THE PROCEDURE. THE SHEATH AND THE DELIVERY SYSTEM WERE REMOVED, BUT THE STENT AND THE DETACHED NOSE CONE REMAINED ON THE WIRE AND STUCK IN THE BIFURCATION OF THE AORTA. BOTH THE STENT AND NOSE CONE WERE SNARED. ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996119 ↗
• MalfunctionMar 16, 2021Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 5.5X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS DEPLOYED. POST-DEPLOYMENT THE REMOVAL STEPS WERE INADVERTENTLY NOT FOLLOWED AND THE SYSTEM WAS PULLED BACK WITHOUT PULLING THE THUMB LEVER. THE NOSE CONE DETACHED; HOWEVER, THE DETACHED NOSE CONE REMAINED ON THE WIRE. THE SESS AND WIRE WITH THE NOSE CONE WERE REMOVED TOGETHER. THE PATIENT IS STABLE. THE DEPLOYED STENT WAS STILL IN PLACE AND SUCCESSFULLY TREATED THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: THE SUPERA STENT WAS PLACED ACROSS THE OCCLUSION AND POST-DILATED WITH A 6MM BALLOON. THE 6X100 BALLOON WAS THEN USED TO TREAT THE NATIVE DISTAL SFA (SUPERFICIAL FEMORAL ARTERY). NOTABLY, AFTER THE STENT DEPLOYMENT A PIECE OF THE STENT DELIVERY SYSTEM CAME OFF ON THE WIRE BUT WAS EASILY REMOVED IN ITS ENTIRETY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11499521 ↗
• MalfunctionMar 3, 2021Stretched; 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 MILDLY CALCIFIED, 90% STENOSED, MID-LEFT SUPERIOR FEMORAL ARTERY (M-L SFA). A 5.5X120MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED BY A NON-TRAINED PHYSICIAN. WHILE DEPLOYING THE STENT, THE DEPLOYER WAS PULLING BACK ON THE CATHETER, AND ELONGATED THE STENT. THE STENT WAS EVENTUALLY REMOVED FROM THE VESSEL VIA SHEATH AND A NON-ABBOTT DEVICE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11407586 ↗
• MalfunctionDec 23, 2020Difficult to Remove; Difficult or Delayed Activation; Difficult to Advance; Physical Resistance/Sticking; Difficult to Remove; Difficult or Delayed Activation; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH MODERATE CALCIFICATION IN THE SUPERIOR FEMORAL ARTERY (SFA) WITH VESSEL DIAMETER OF 5.5MM. THE LESION WAS DISTAL TO A PREVIOUSLY IMPLANTED NON-ABBOTT RESTENOSED STENT. A 6FR X 50 CM SHEATH WAS PLACED. THE STENT RESTENOSIS WAS DILATED BY AN UNSPECIFIED BALLOON. A 5.5 X 120 MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE IMPLANTED AT THE DE NOVO LESION OVERLAPPING WITH THE PREVIOUSLY IMPLANTED NON-ABBOTT STENT; HOWEVER, THE TIP OF THE SUPERA GOT CAUGHT [UNABLE TO ADVANCE FURTHER OR REMOVE]. THE SESS WAS MANIPULATED AND THE SESS WAS FINALLY FREED AND THE STENT DEPLOYED. RESISTANCE WITH THE THUMBSLIDE WAS ALSO NOTED ON DEPLOYMENT OF THE STENT. THE SUPERA STENT WAS ULTIMATELY SUCCESSFULLY IMPLANTED AT THE TARGET LESION AND THE SESS 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 11067265 ↗
• MalfunctionAug 6, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Activation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTALLY OCCLUDED AND HEAVILY CALCIFIED DE NOVO LESION IN THE MID TO PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED 6.0 HIGH-PRESSURE BALLOON AT 12 ATMOSPHERES FOR 60 SECONDS AND ATHERECTOMY. A 5.5X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND DEPLOYED. THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE WAS ADVANCED COMPLETELY AND THE USE OF FLUOROGRAPHY WAS STOPPED AND THE SESS WAS REMOVED. NO RESISTANCE WAS FELT DURING REMOVAL; HOWEVER, RE-FLOW BLOOD WAS OBSERVED FROM THE Y-CONNECTOR WHEN THE SESS CROSSED THROUGH IT. IT WAS THEN NOTED THAT THE STENT WAS STUCK IN THE Y-CONNECTOR. THE STENT WAS NOTED TO BE STRETCHED AND DISLODGED FROM THE SESS. THE STENT WAS ABLE TO BE PULLED OUT OF THE Y-CONNECTOR SMOOTHLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF A 5.0X120MM SUPERA STENT IN THE MID RIGHT SFA AND A NEW 5.5X120MM SUPERA STENT OVERLAPPED AT THE PROXIMAL. 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 10374876 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS, NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. THREE SUPERA STENTS (5.0X80MM, 5.0X60MM, AND 5.5X120MM) AND A NON-ABBOTT STENT WERE SUCCESSFULLY PLACED IN THE LESION. BLOOD FLOW WAS LIMITED AS ONLY A TRICKLE WAS NOTED THROUGH THE STENTS. A BLOCKAGE WAS SUSPECTED BUT UNABLE TO IDENTIFY OR CONFIRM AS THROMBUS. BYPASS SURGERY WAS DONE AS TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 8962274 ↗
• MalfunctionJun 14, 2019Off-Label Use; Difficult or Delayed Activation; Defective Device; Material Deformation; Off-Label Use; Difficult or Delayed Activation; Defective Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY TORTUOUS, HEAVILY CALCIFIED, 95% STENOSED MID TO PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS PREPARED WITH AN UNSPECIFIED 6X200MM BALLOON CATHETER AT 14 ATMOSPHERES FOR TWO MINUTES, AND A 6FRX45CM NON-ABBOTT SHEATH WAS USED. A 5.5X120 SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND DEPLOYED PER THE INSTRUCTIONS FOR USE; HOWEVER, DIFFICULTY DEPLOYING THE STENT WAS NOTED. THE STENT PARTIALLY DEPLOYED AND DUE TO INVAGINATION SHORTENED AFTER BEING FULLY DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. 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 8700740 ↗
• InjuryMay 10, 2019Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS, CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. THE VESSEL DIAMETER WAS 6MM AND A 6F SHEATH WAS PLACED. THE LESION WAS PREPPED WITH AN UNSPECIFIED 6.0 X 220 MM BALLOON DILATATION CATHETER TO A 6MM DIAMETER. A 5.5 X 120 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS DEPLOYED. THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE ADVANCED TO THE MOST DISTAL PORTION OF THE HANDLE. WHILE THERE WERE NO REPORTED PROBLEMS WITH THE STENT DEPLOYMENT, FOLLOWING THE SESS BEING REMOVED, THE DEPLOYED STENT APPEARED TO DEFORM (KINKED AND TWISTED). BALLOON ANGIOPLASTY AND STENT MANIPULATION WERE SUCCESSFULLY PERFORMED TO CORRECT THE STENT DEFORMATION. THE STENT DID NOT ELONGATE AND POST ADDITIONAL INTERVENTION, THERE WERE NO FURTHER CONCERNS REGARDING THE CONDITION OF THE DEPLOYED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601990 ↗
• MalfunctionDec 12, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.5X120 MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) THE TIP SEPARATED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8158255 ↗
• MalfunctionDec 1, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING UNPACKING OF A 5.5X120MM SUPERA PERIPHERAL STENT SYSTEM, IT APPEARED THAT THE STENT WAS NOT FULLY INSIDE THE CATHETER AS IT WAS NOTED THAT A PART OF THE STENT IMPLANT WAS STICKING OUT (EXPOSED AND NOT FLOWERED). THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SUPERA 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 Patient Involvement

  MAUDE report 8123077 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE 5.0X120MM SUPERA STENT WAS IMPLANTED ON (B)(6) 2018 IN A LESION IN THE LEFT LEG WITH NO ISSUES. ON (B)(6) 2018, THE PATIENT PRESENTED WITH A COLD LEG AND ACUTE SHUT DOWN OF THE SUPERA STENT WAS NOTED. THROMBOLYSIS WAS PERFORMED AND TWO ABSOLUTE STENTS WERE DEPLOYED, ONE DISTAL AND ONE PROXIMAL TO THE SUPERA STENT. THE PATIENT WAS STABLE AND THE FINAL PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Thrombosis

  MAUDE report 8091380 ↗
• MalfunctionAug 1, 2018Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED. DURING DEPLOYMENT OF THE 5.5 X 120 MM SUPERA STENT SYSTEM, THE STENT WOULD NOT RELEASE, THE STENT THEN ELONGATED, DOUBLED IN LENGTH AND THE STENT RELEASED. THE STENT WAS DEPLOYED IN THE TARGET LESION AND UNHEALTHY TISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739379 ↗