SUPERA S-65-040-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648226229), received between May 6, 2019 and Feb 10, 2026 — classified as 8 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (6 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 CHRONIC TOTAL OCCLUSION OF THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS PRE-DILATED WITH A 6MM NON-COMPLIANT BALLOON. THE 6.50X40MM 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 24303065 ↗
• MalfunctionJan 20, 2026Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. PRE-DILATATION WAS PERFORMED AND THE 6.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED. DURING STENT DEPLOYMENT, RESISTANCE WAS NOTED WITH THE THUMB SLIDE AND STENT ELONGATION OCCURRED DURING PLACEMENT. IT WAS NOTED THAT THE LESION DID NOT EXPAND AS WELL AS EXPECTED DURING PRE-DILATATION. THE SUPERA SESS WAS REMOVED, AND PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED 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 24124765 ↗
• MalfunctionDec 12, 2024Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER THE LESION WAS ACCESSED WITH A 300CM NON-ABBOTT GUIDEWIRE, AND PRE-DILATED WITH A 7MM BALLOON CATHETER, A 6X40MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED INTO THE ANATOMY THROUGH A 6F SHEATH, HOWEVER THE THUMBSLIDE WAS NOTED TO JAM AND THE STENT COULD ONLY BE PARTIALLY DEPLOYED. THE PARTIALLY DEPLOYED SUPERA WAS REMOVED AND ANOTHER SUPERA SES WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914462 ↗
• MalfunctionOct 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE TORTUOSITY. THE 6.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED SUCCESSFULLY IN A PROCEDURE; HOWEVER, THE TIP OF THE DELIVERY SYSTEM SEPARATED DURING REMOVAL. THE SEPARATED TIP REMAINED HANGING ON THE GUIDEWIRE (GW) AND WAS ABLE TO BE REMOVED FROM THE PATIENT. 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 17986383 ↗
• InjuryFeb 27, 2023Activation Failure; Migration; Activation Failure; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 6.5 MM PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH NO CALCIFICATION OR TORTUOSITY. THE VESSEL WAS PREPARED WITH A 7X40 MM BALLOON. ATHERECTOMY WAS NOT USED. THE 6.5X40 MM SUPERA SELF EXPANDING STENT (SES) PARTIALLY (ABOUT 5 MM) DEPLOYED IN THE SHEATH. WHEN THE SHEATH WAS PULLED, THE STENT MOVED INTO THE COMMON FEMORAL/EXTERNAL ILIAC ARTERY AND REMAINS THERE. THIS IS AN UNINTENDED LOCATION. THE TARGET LESION WAS NOT TREATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16448579 ↗
• InjuryJan 16, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Migration; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS, HEAVY CALCIFICATION AND MILD TORTUOSITY. PRE-DILATATION WAS PERFORMED INFLATING 5 TIMES AT 20 ATMOSPHERES FOR 120 SECONDS TO COMMON FEMORAL ARTERY (CFA)-SFA. LESION SIZE WAS 6.5X100MM. THE 6.5X40MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) HAD RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND WAS DEPLOYED IN THE CFA USING CROSSOVER APPROACH. IT WAS NOTED THAT THE DISTAL TIP SEPARATED. THERE WAS RESISTANCE DUE TO THE ANATOMY DURING WITHDRAWAL AND SOME FORCE WAS APPLIED. AS RETRIEVAL OF THE SEPARATED TIP WAS ATTEMPTED, THE SUPERA STENT MIGRATED TO THE EXTERNAL ILIAC ARTERY SO THE SHEATH WAS INSERTED INTO THE IPSILATERAL SIDE. THEN SUPERA STENT AND SEPARATED TIP WERE REMOVED BY SNARE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16179392 ↗
• InjurySep 30, 2022Stretched; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION. THE VESSEL DIAMETER WAS 6.5MM. THE LESION WAS PREPARED WITH A 6.0MM BALLOON AT AN UNKNOWN PRESSURE. A 6FRENCH SHEATH WAS ADVANCED. THE 5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED, HOWEVER, THE STENT ELONGATED IN THE SHEATH. THE STENT ELONGATED GREATER THAN 10% OF THE EXPECTED LENGTH AND A PART OF THE STENT WAS IN HEALTHY TISSUE. ANOTHER STENT WAS USED TO REALIGN THE DEPLOYED SUPERA STENT. 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 15509211 ↗
• InjuryJan 24, 2022Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT SUPERIOR FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. USING A CROSSOVER TECHNIQUE TO AVOID RESISTANCE AND AFTER PRE-DILATION WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC), A 6.5X40MM SUPERA PERIPHERAL SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION. HOWEVER, DURING DEPLOYMENT, RESISTANCE WAS FELT ADVANCING THE THUMBSLIDE. THE STENT PARTIALLY DEPLOYED AND THE THUMBSLIDE BECAME STUCK. A PUNCHER NEEDLE WAS USED TO KEEP THE STENT AT THE TARGET LESION AND THE DELIVERY SYSTEM WAS PULLED SLIGHTLY TO COMPLETE THE STENT DEPLOYMENT. ALTHOUGH DEPLOYMENT WAS DIFFICULT, THE STENT WAS ABLE TO BE DEPLOYED AT THE INTENDED LOCATION. 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 13334455 ↗
• InjuryJan 20, 2022Difficult or Delayed Activation; Defective Device; Malposition of Device; Migration; Difficult or Delayed Activation; Defective Device; Malposition of Device; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL DIAMETER WAS 6.3 MM AND ATHERECTOMY WAS NOT PERFORMED. PRE-DILATATION WAS PERFORMED WITH A 6X40 MM NON-ABBOTT BALLOON FOR 120 SECONDS AT 24 ATMOSPHERES TWICE. THE 6.5X40 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYED; HOWEVER, THE STENT BEGAN TO SHORTEN AND SLIP OUT OF PLACE FROM THE TARGET LESION DURING DEPLOYMENT. SOME OF THE STENT WENT INTO HEALTHY TISSUE WHILE SOME REMAINED IN THE TARGET LESION. THE PHYSICIAN STATED IT WAS POSSIBLE THE STENT MOVED DURING DEPLOYMENT. NEXT, A 6.5X80 MM SUPERA SESS WAS ADVANCED AND WAS DEPLOYED. HOWEVER, THE STENT ELONGATED WHEN THE DELIVERY SYSTEM WAS REMOVED AND SOME WENT INTO HEALTHY TISSUE, WHILE SOME REMAINED IN THE TARGET LESION. IT WAS ATTEMPTED TO RETRIEVE THE STENT USING A NON-ABBOTT SHEATH BUT THE DELIVERY SYSTEM WAS STUCK COMPLETELY AND FAILED TO REMOVE ALL OF THE STENT AND DELIVERY SYSTEM. THE TIP OF THE SUPERA IS DAMAGED. SURGERY WAS PERFORMED TO RETRIEVE THE DELIVERY SYSTEM, STENT AND THE FIRST IMPLANTED STENT AS WELL. FINAL PATIENT OUTCOME IS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 13308643 ↗
• InjuryApr 6, 2021Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  IT WAS REPORT THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, NON-TORTUOUS DE NOVO LESION IN THE RIGHT COMMON FEMORAL ARTERY THAT WAS 90% STENOSED. VESSEL DIAMETER WAS 7.0MM, LESION LENGTH WAS 30MM. USING CONTRALATERAL FEMORAL APPROACH, PRE-DILATATION WAS PERFORMED WITH A 5.0X40MM NON-ABBOTT BALLOON AND A 6.5X40MM NON-ABBOTT BALLOON (12ATM 60 SECONDS 2 TIMES / 16ATM 120 SECONDS 1 TIME). THE 6.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM WAS ADVANCED USING A 28CM SHEATH AND A NON-ABBOTT GUIDEWIRE. DURING DEPLOYMENT, THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMBSLIDE WAS ADVANCED TO DEPLOY THE STENT, HOWEVER, THE STENT DID NOT RELEASE. THE THUMBSLIDE WAS PULLED BACK AND ADVANCED MULTIPLE TIMES WITHOUT SUCCESS. THE SHAFT WAS THEN PULLED BACK FOR REMOVAL WHICH CAUSED THE STENT TO RELEASE IN THE TARGET LESION. THERE WAS A SLIGHT ELONGATION OF THE STENT WHICH WAS RECOVERED BY POST DILATATION. PER THE PHYSICIAN'S OPINION, THERE WAS NO ISSUE DEPLOYING THE MIDDLE SECTION, THEREFORE THE CAUSE OF DEPLOYMENT FAILURE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623855 ↗
• MalfunctionMar 29, 2021Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A 100% STENOSED LESION IN THE RIGHT COMMON FEMORAL ARTERY, WITH NO BLOOD FLOW TO THE RIGHT LEG. THE VESSEL DIAMETER WAS 7 TO 7.25 MM. THE LESION WAS BALLOONED AND A 6.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED. THE STENT PARTIALLY FLOWERED AS THE DEPLOYMENT HAD INITIATED, THE PHYSICIAN PULLED THE STENT BACKWARDS IN ORDER TO RE-POSITION THE STARTING POINT AND PART OF THE STENT MOVED INTO THE SHEATH BECAUSE THE STENT WAS UNDERSIZED AND THEREFORE NOT APPOSED TO THE VESSEL WALL. THE OTHER HALF OF THE STENT WAS STILL IN THE ANATOMY. THE PHYSICIAN DID NOT NOTICE THAT PART OF THE STENT WAS STILL IN THE SHEATH. HE DEPLOYED PART OF THE STENT IMPLANT INTO THE SHEATH AND RESISTANCE WAS FELT. THE SESS, THE PARTIALLY DEPLOYED STENT AND SHEATH WERE SIMPLY REMOVED ALTOGETHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THE DECISION WAS MADE TO TREAT THE LESION WITH ENDARTERECTOMY SURGERY. SUBSEQUENT TO FILING THE INITIAL REPORT, ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THE INNER MEMBER, INCLUDING THE TIP, WAS SEPARATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ACCOUNT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585723 ↗
• MalfunctionAug 27, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A HEAVILY CALCIFIED DE NOVO SUPERIOR FEMORAL ARTERY (SFA). A 6.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS SUCCESSFULLY IMPLANTED. DURING REMOVAL WITH FLUOROSCOPY OF THE STENT DELIVERY SYSTEM SOME RESISTANCE WAS MET WITH A NON-ABBOTT Y-CONNECTOR. THE TIP SEPARATED BUT REMAINED ON THE GUIDE WIRE AND WAS REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO SIGNIFICANT CLINICALLY DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459884 ↗
• MalfunctionMar 16, 2020Stretched; 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 75% STENOSED AND HEAVILY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. A 6F SHEATH AND A HT COMMAND 18 GUIDE WIRE WERE ADVANCED TO THE LESION. FOLLOWING PRE-DILATATION, A 6.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM WAS ADVANCED AND AN ATTEMPT TO DEPLOY THE STENT WAS PERFORMED. THE THUMB SLIDE WAS ADVANCED; HOWEVER, THE LAST 1CM FAILED TO DEPLOY DESPITE FURTHER THUMB SLIDE ADVANCEMENTS. THE DEPLOYMENT LOCK WAS RELEASED; HOWEVER, THE STENT DID NOT FULLY DEPLOY. THE DELIVERY SYSTEM WAS PULLED SLOWLY OUT OF THE ANATOMY UNDER FLUOROSCOPY AND THE STENT COMPLETELY DEPLOYED FROM THE SYSTEM. THE IMPLANTED STENT SEEMED TO BE ELONGATED BY 30% AT THE 1CM SECTION THAT DEPLOYED WITH THE REMOVAL OF THE DELIVERY SYSTEM. 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 9837791 ↗
• InjuryJan 27, 2020Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 75% STENOSED LEFT COMMON FEMORAL ARTERY. AN UNSPECIFIED SHEATH WAS USED WITH A COMMAND 18 300CM GUIDE WIRE AND A NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION. A 6.5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITH RESISTANCE FROM A PREVIOUSLY DEPLOYED STENT IN THE EXTERNAL ILIAC ARTERY. THE SUPERA STENT WAS IMPLANTED IN THE TARGET LESION, AND THE TIP FACED RESISTANCE DURING REMOVAL WITH THE PREVIOUSLY DEPLOYED STENT AND SEPARATED. A SNARE WAS ATTEMPTED TO RETRIEVE THE TIP, BUT IT FAILED TO REACH BECAUSE THE GUIDE WIRE WAS PLACED ON THE STENT STRUT OF THE PREVIOUSLY DEPLOYED STENT. A CUT DOWN WAS NOT PERFORMED, AND THE TIP WAS RETRIEVED USING FORCEPS. THERE WERE NO REPORTED ISSUES WITH THE COMMAND 18 GUIDE WIRE, AND AN UNSPECIFIED 6.5X60MM 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 9632559 ↗
• MalfunctionNov 15, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION (PCI) TREATING A PREVIOUSLY PLACED NON-ABBOTT STENT THAT HAD FRACTURED, LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATATION WAS PERFORMED USING A 7.0X20MM MUSTANG BALLOON AND A SUPERA STENT DELIVERY SYSTEM (SDS) WAS SELECTED DUE TO THE DESIRED RADIAL STRENGTH. THE SUPERA SDS ADVANCED TO THE PREVIOUSLY IMPLANTED STENT WITHOUT REPORTED ISSUES. DURING DEPLOYMENT, THE STENT HAD STOPPED RATCHETING AND WAS NO LONGER DEPLOYING. STANDARD TROUBLESHOOTING WAS PERFORMED; THE SUPERA HANDLE WAS ROTATED AND RE-POSITIONED UPWARDS. THE SUPERA STENT HAD THEN CONTINUED TO DEPLOY WITHOUT FURTHER ISSUES. THE SUPERA STENT WAS IMPLANTED IN THE INTENDED AREA WITHOUT STRETCHING OBSERVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9331221 ↗
• MalfunctionOct 14, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE DISTRIBUTION CENTER WAS PERFORMING AN INSPECTION ON A 6.5 X 40 MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS), AND A CRACK WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS WAS COMPLETED AND THE RESULTS REVEALED THAT A PIECE OF THE SHEATH FLUSH PORT WAS CHIPPED OFF AT THE PROXIMAL END OF THE SHEATH FLUSH PORT.

  Patient problems: No Patient Involvement

  MAUDE report 9186142 ↗
• InjurySep 27, 2019Device Damaged by Another Device; Migration; Device Damaged by Another Device; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE, WITH IMPLANTATION OF A 6.5 X 40 MM SUPERA STENT IN THE RIGHT COMMON FEMORAL ARTERY. ON (B)(6) 2019, THE PATIENT UNDERWENT A CORONARY ANGIOGRAPHY, FOR PERCUTANEOUS CORONARY INTERVENTION. A 4 FRENCH (FR) SYSTEM WAS USED FOR THE CORONARY ANGIOGRAPHY; HOWEVER, THE SHEATH WAS REPLACED WITH A 6FR SHEATH AND INSERTED, WITHOUT THE PHYSICIAN CHECKING PLACEMENT ON IMAGING. THE 6FR SHEATH INTERACTED WITH THE IMPLANTED SUPERA STENT, PUSHING THE STENT FROM THE RIGHT COMMON FEMORAL ARTERY INTO THE EXTERNAL ILIAC ARTERY. THERE WERE NO ISSUES NOTED WITH BLOOD FLOW; THEREFORE, NO ADDITIONAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9132270 ↗
• MalfunctionMay 6, 2019Migration; Activation Problem

  THERE WAS A FLOW-LIMITING DISSECTION IN THE DISTAL COMMON FEMORAL ARTERY (CFA) AND A 5.5MM X 80 SUPERA STENT WAS DEPLOYED. WE THEN WENT TO OVERLAP A 6.5 X 40 SUPERA STENT WITH THIS. THE INTENDED LOCATION WAS FOR THE RIGHT COMMON FEMORAL ARTERY IN THE MID TO DISTAL SEGMENT. AT THE POINT OF NEAR COMPLETE DEPLOYMENT, THE UNLOCKING AND UNLEASHING MECHANISM FROM THE SUPERA SHAFT WAS STUCK. IT DID NOT WORK. IN THE PROCESS OF PULLING THE CARCASS OF THE STENT OUT, THE SUPERA STENT ALSO MIGRATED NORTH TO THE AORTIC BIFURCATION. WE WERE ABLE TO RETRIEVE THE DISTAL PLASTIC NOSE RING OF THE SUPERA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8581848 ↗