SUPERA S-50-040-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648211737), received between Aug 9, 2018 and May 26, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2025Improper 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 MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER THE VESSEL WAS PREPARED USING A 5.0MM UNKNOWN BALLOON CATHETER TO 8ATMS FOR 2MINS, A 5X40MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE LESION THROUGH A 6FR SHEATH AND SUCCESSFULLY DEPLOYED WITH THE PROXIMAL END OF THE STENT 10-15CM AWAY FROM THE SHEATH. HOWEVER, UPON THE REMOVAL OF THE DEVICE, NOT UNDER FLUOROSCOPY, IT WAS NOTED THAT THE STENT AND CATHETER TIP REMAINED INSIDE THE INTRODUCER SHEATH. THERE WERE NO ADVERSE PATIENT EFFECT NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. SUBSEQUENT TO THE INITIALLY REPORTED INFORMATION, THE DEVICE WAS RECEIVED AND THE RETURNED DEVICE ANALYSIS REVEALED THAT THE TIP, TIP LUMEN, AND TIP JACKET WERE SEPARATED AT THE DISTAL END OF THE RATCHET STEM, AND THE DISTAL END OF THE STENT IMPLANT WAS STRETCHED AND HAD BROKEN STRUTS. THE ACCOUNT CONFIRMED TO BE AWARE OF THE FOUND DAMAGES AND NOTED THAT THEY OCCURRED DURING PHYSICIAN HANDLING POST-PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084445 ↗
• MalfunctionJan 24, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Activation Failure; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE MODERATELY CALCIFIED RIGHT POPLITEAL ARTERY. THE LESION WAS PREPPED WITH A 5MM BALLOON TO NOMINAL PRESSURE. A 5.0X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE OVER A COMMAND GUIDEWIRE; HOWEVER, ON DEPLOYMENT THE STENT DID NOT FULLY DEPLOY, AND THE TIP BROKE FROM THE SHAFT. THE ENTIRE SDS INCLUDING THE PARTIALLY DEPLOYED STENT AND SEPARATED TIP WAS RETRIEVED FROM THE PATIENT BY SIMPLY PULLING THE SYSTEM THROUGH THE 6F SHEATH AGAINST RESISTANCE. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572684 ↗
• InjuryDec 22, 2021Material Separation; Stretched; Improper or Incorrect Procedure or Method; Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MILDLY CALCIFIED AND MILDLY TORTUOUS VESSEL IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS 5.0MM. PRE-DILATATION WAS NOT PERFORMED AND ATHERECTOMY WS NOT USED. BECAUSE THERE WAS LESION AT BOTH (LEFT AND RIGHT) VESSEL, PUNCTURE WAS DONE ANTEGRADELY FROM LEFT SFA AND A 5.0X80MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED AT LEFT SFA. THEN, APPROACH WAS CHANGED TO CROSS-OVER APPROACH TECHNIQUE, TOTAL OCCLUDED LESION AT RIGHT POPLITEAL VESSEL WAS ATTEMPTED TO BE TREATED. A GUIDE WIRE WAS ATTEMPTED TO CROSS THE LESION, BUT IT FAILED TO CROSS. WHEN THE LAST FLUOROGRAPHY WAS DONE, DISSECTION AT LEFT SFA WAS NOTED. THE 5.0X40MM SUPERA SESS WAS IMPLANTED TO TREAT THE DISSECTION BUT THE STENT BECAME ELONGATED [STRETCHED] BECAUSE OF NO PRE-DILATATION. THERE WAS NO RESISTANCE DURING ADVANCEMENT. POST-DILATATION WAS PERFORMED TO TREAT THE DISSECTION. HOWEVER, IT WAS NOTED THAT THE TIP OF THE SESS HAD SEPARATED AND REMAINED IN THE PATIENT'S BODY FLOATING FREELY DISTAL OF THE STENT AT SFA BUT NO BLOOD FLOW DISTAL OF P1. THE THUMB SLIDE WAS NOT FULLY RETRACTED TO THE START POSITION AND BOTH THE SYSTEM AND DEPL

  Patient problems: Foreign Body In Patient

  MAUDE report 13061564 ↗
• InjuryNov 26, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE ENDOVASCULAR THERAPY (EVT) PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED VESSEL IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS 5.0MM AND THE LESION LENGTH WAS 180MM. THE EVT WAS STARTED BY TAI (TRANS ANKLE INTERVENTION) AND A NON-ABBOTT STENT WAS IMPLANTED. HOWEVER, STENT RECOIL WAS SIGNIFICANT DUE TO PART OF THE CALCIFICATION AND INSUFFICIENT STENT EXPANSION WAS CONFIRMED. ATHERECTOMY WAS NOT USED. THE 5.0X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED IN THE NON-ABBOTT STENT AND THERE WAS NO RESISTANCE DURING ADVANCEMENT. THERE WAS HEAVY RESISTANCE DURING WITHDRAWAL BECAUSE THE TIP OF THE SUPERA STENT GOT STUCK WITH THE NON-ABBOTT IMPLANTED STENT AND FORCE WAS APPLIED THAT THE TIP OF THE DELIVERY SYSTEM SEPARATED. IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE STENT EMERGED FROM THE SHEATH AND WAS FULLY RELEASED. THERE WAS NO WASTE NOTED TO THE DEPLOYED STENT OR PROXIMAL END OF LESION. THE THUMB SLIDE FULLY RETRACTED TO THE START POSITION AND BOTH THE SYSTEM AND DEPLOYMENT LEVERS WERE LOCKED PRIOR TO REMOVAL. THE SEPARATED TIP WAS REMOVED FROM THE ANATOMY BY USING A SNARE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12879681 ↗
• MalfunctionJun 1, 2021Difficult or Delayed Positioning; Stretched; Activation Failure; Difficult or Delayed Positioning; Stretched; Activation Failure

  IT WAS REPORTED THAT THE CROSS OVER PROCEDURE WAS PERFORMED TO TREAT AN 100% STENOSED, MILDLY TORTUOUS, AND HEAVILY CALCIFIED DE NOVO LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. ALTHOUGH PRE-DILATATION WAS PERFORMED TWICE WITH A NON-ABBOTT BALLOON CATHETER AT 8-10 ATMOSPHERES FOR 170 SECONDS, THE INDENTATION COULD NOT BE COMPLETELY REMOVED DUE TO THE HEAVY CALCIFICATION. AN ATTEMPT TO DEPLOY A 5.0X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS MADE; HOWEVER, ELONGATION OCCURRED AND THE STENT WAS ABOUT TO DEPLOY IN THE GUIDING CATHETER. ADDITIONALLY, DIFFICULTY VISUALIZING THE STENT DURING DEPLOYMENT WAS NOTED. THE SESS WAS REMOVED FROM THE PATIENT UNDER FLUOROSCOPY. ONCE OUTSIDE THE ANATOMY, THE SESS WAS INSPECTED AND IT WAS NOTED THAT THE TIP OF THE STENT WAS CONSTRICTED AND HAD NOT EXPANDED CLEARLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT 6.0X40MM STENT. 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 11916372 ↗
• MalfunctionDec 9, 2020Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED BY AN UNSPECIFIED BALLOON. A 5X40MM SUPERA STENT WAS ADVANCED TO THE LESION AND DEPLOYMENT INITIATED. HOWEVER, THE INTRODUCER SHEATH WAS FAR AWAY FROM THE PROXIMAL END OF THE STENT DURING DEPLOYMENT WHICH CAUSED THE STENT TO ONLY PARTIALLY DEPLOY (PROXIMAL END OF STENT REMAINED ON CATHETER). THE DEVICE WAS SIMPLY WITHDRAWN. IT WAS ATTEMPTED TO ADVANCE ANOTHER SAME SIZE SUPERA, BUT THE SAME ISSUE OCCURRED AND THEREFORE REMOVED. BOTH DELIVERY SYSTEMS WERE NOT REMOVED UNDER FLUOROSCOPY. THERE WERE NO REPORTED ISSUES WITH THE THUMBSLIDE MECHANISM. A NON-ABBOTT 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 Consequences Or Impact To Patient

  MAUDE report 10978823 ↗
• MalfunctionDec 9, 2020Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED BY AN UNSPECIFIED BALLOON. A 5X40MM SUPERA STENT WAS ADVANCED TO THE LESION AND DEPLOYMENT INITIATED. HOWEVER, THE INTRODUCER SHEATH WAS FAR AWAY FROM THE PROXIMAL END OF THE STENT DURING DEPLOYMENT WHICH CAUSED THE STENT TO ONLY PARTIALLY DEPLOY (PROXIMAL END OF STENT REMAINED ON CATHETER). THE DEVICE WAS SIMPLY WITHDRAWN. IT WAS ATTEMPTED TO ADVANCE ANOTHER SAME SIZE SUPERA, BUT THE SAME ISSUE OCCURRED AND THEREFORE REMOVED. BOTH DELIVERY SYSTEMS WERE NOT REMOVED UNDER FLUOROSCOPY. THERE WERE NO REPORTED ISSUES WITH THE THUMBSLIDE MECHANISM. A NON-ABBOTT 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 Consequences Or Impact To Patient

  MAUDE report 10978813 ↗
• MalfunctionFeb 7, 2020Difficult or Delayed Activation; Defective Device; Difficult or Delayed Activation; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-TORTUOUS, MILDLY CALCIFIED POPLITEAL ARTERY. A 5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION, BUT IT FAILED TO COMPLETELY DEPLOY THE STENT. TO FULLY DEPLOY THE STENT, THE SESS WAS PULLED BACK, BUT THIS CAUSED THE STENT TO BE DEPLOYED PARTIALLY IN THE INTENDED POPLITEAL ARTERY. THE DEPLOYED STENT WAS SHORTENED, AND THE PATIENT IS FINE. 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 9681506 ↗
• MalfunctionSep 27, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT A DEPLOYMENT ISSUE WAS NOTED WITH A 5.0 X 40 MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131748 ↗
• InjuryJul 12, 2019Material Separation; Patient-Device Incompatibility; Material Separation; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CALCIFIED, CHRONIC TOTALLY OCCLUDED, SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS PREPARED PER THE INSTRUCTIONS FOR USE AND WITH ATHERECTOMY. THE 5X40MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS DEPLOYED; HOWEVER, THE STENT DID NOT FULLY APPOSE TO THE VESSEL WALL DUE TO PLAQUE AND CALCIUM. DURING REMOVAL OF THE SESS UNDER FLUOROSCOPY, THE TIP OF THE NOSE CONE SEPARATED. THE NOSE CONE REMAINS IN THE PATIENT ANATOMY AND NO TREATMENT WAS PERFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8786033 ↗
• InjuryAug 9, 2018Material Separation; Difficult or Delayed Activation; Patient-Device Incompatibility; Physical Resistance/Sticking; Material Separation; Difficult or Delayed Activation; Patient-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, PROXIMAL RIGHT SUPERFICIAL FEMORAL, AFTER VESSEL PRE-DILATATION, THE SUPERA STENT WAS HALF-WAY DEPLOYED WHEN THE THUMBSLIDE RACHET SLIPPED AND THE STENT COULD NOT BE DEPLOYED. MULTIPLE STEPS WERE TAKEN TO RE-ENGAGE THE MECHANISM WHEN THE TIP DETACHED. THE STENT EVENTUALLY WAS FULLY DEPLOYED WITH THE TIP IN THE VESSEL; HOWEVER, WITH A SUBOPTIMAL APPOSITION. A SNARE DEVICE WAS USED TO RETRIEVE THE DETACHED TIP FROM THE VESSEL. ADDITIONALLY, DURING THE TIP RETRIEVAL ATTEMPTS, A NON-ABBOTT GUIDE WIRE TIP BECAME DISLODGED AND DETACHED. THIS WAS A TANDEM PROCEDURE AND THE PATIENT WAS SCHEDULED FOR A VASCULAR SURGICAL INTERVENTION UNRELATED TO THE STENT PROCEDURE. DURING THE SURGERY, THE GUIDE WIRE TIP WAS REMOVED ALONG WITH THE SUPERA STENT. 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 7771008 ↗