SUPERA S-55-040-120-P6 (UDI 08975370026283)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08975370026283), received between Aug 8, 2016 and Apr 2, 2018 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2018Positioning Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE 5.5 X 40 MM SUPERA VERITAS STENT DELIVERY SYSTEM WAS ADVANCED WITHOUT ISSUE TO THE LESION; HOWEVER, DURING THE ATTEMPT TO DEPLOY THE STENT, THE STENT WOULD NOT FULLY RELEASE FROM THE DELIVERY CATHETER. THE VESSEL WAS 5.5 MM IN DIAMETER AND WAS PRE-DILATED WITH A 6.0 X 120 MM DRUG COATED BALLOON. IT WAS THOUGHT THAT THE STENT WAS DEPLOYED, UNTIL RETRACTION OF THE STENT DELIVERY SYSTEM WHEN IT WAS OBSERVED ON FLUOROSCOPY THAT THE STENT IMPLANT WAS NOT FULLY RELEASED FROM THE DELIVERY CATHETER. THE UNDEPLOYED STENT WAS RETRACTED BACK INTO THE SHEATH AND REMOVED ALONG WITH THE DELIVERY CATHETER. NO FURTHER TREATMENT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7389821 ↗
• MalfunctionFeb 22, 2018Detachment Of Device Component

  IT WAS REPORTED THAT DURING REMOVAL OF THE SUPERA STENT DELIVERY SYSTEM (SDS) FROM THE PACKAGING, THE TECHNICIAN PULLED ON THE WHITE TIP WHICH SEPARATED THE TIP FROM THE DELIVERY CATHETER. THE DEVICE COULD NOT BE USED ON THE PATIENT. A NEW SUPERA SDS WAS USED SUCCESSFULLY ON THE PATIENT TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7291142 ↗
• InjuryDec 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT THROMBOSIS WAS OBSERVED VIA ANGIOGRAPHY IN THE SUPERA STENTS THAT WERE DEPLOYED ON (B)(6) 2016. THE STENTS WERE LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND THE POPLITEAL. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT ISSUE. THERE WAS NO RECORD OF EXISTING THROMBOSIS IN THE PATIENT PRIOR TO STENTING. THE PATIENT WAS EXPERIENCING PAIN AT REST WHICH LED TO THE ANGIOGRAPHY WHICH TOOK PLACE ON (B)(6) 2016 REVEALING IN-STENT THROMBOSIS. THROMBOLYSIS WAS PERFORMED AND ON THE FOLLOWING DAY A NON-ABBOTT STENT WAS PLACED. THE PATIENT RETURNED AGAIN APPROXIMATELY 1 MONTH LATER WITH REPEAT IN-STENT THROMBOSIS FOR WHICH THE PATIENT WAS SENT FOR SURGERY FOR AN ABOVE THE KNEE AMPUTATION. IT WAS CONFIRMED THAT THE PATIENT HAD NOT BEEN COMPLIANT WITH HIS POST-PROCEDURAL MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Thrombosis

  MAUDE report 7139874 ↗
• InjurySep 19, 2017Detachment Of Device Component; Difficult To Position; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POPLITEAL THAT WAS DESCRIBED AS FIBRO-CALCIFIC. AFTER PLACEMENT OF A 6FR X 55 CM SHEATH, THE VESSEL WAS PREPPED PER SUPERA INSTRUCTIONS FOR USE. PREDILATATION WAS PERFORMED ON THE 5 MM VESSEL WITH AN ARMADA BALLOON CATHETER. A 5.5 X 40 SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED THROUGH THE SHEATH AGAINST RESISTANCE, THEN TO THE LESION. THE STENT WAS DEPLOYED WITHOUT DIFFICULTY AND WAS FULLY RELEASED. THE THUMBSLIDE WAS CONFIRMED TO BE IN THE LOCKED POSITION AND THE DELIVERY SYSTEM WAS WITHDRAWN WITH SLIGHT RESISTANCE FELT WITH THE DEPLOYED STENT RESULTING IN THE NOSE CONE / TIP SEPARATING IN THE VESSEL. THE NOSE CONE / TIP WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6877215 ↗
• InjuryApr 12, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A PERIPHERAL STENTING PROCEDURE WITH IMPLANTATION OF THE 5.5 X 40 MM SUPERA STENT IN THE LEFT SUPERFICIAL FEMORAL ARTERY. NO ISSUES WERE NOTED DURING STENT IMPLANTATION. ON (B)(6) 2017, THE PATIENT UNDERWENT ANGIOGRAPHY DUE TO CLAUDICATION OF THE LEFT LOWER EXTREMITY AND RESTENOSIS WAS NOTED IN THE SUPERA STENT. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2017 WITH IMPLANTATION OF AN ADDITIONAL SUPERA STENT INSIDE THE PREVIOUS SUPERA STENT. PATIENT WAS IN STABLE CONDITION POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Stenosis

  MAUDE report 6486839 ↗
• MalfunctionNov 16, 2016Positioning Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, UNSPECIFIED LESION. THERE WAS RESISTANCE DEPLOYING THE LAST PART OF A 5.5 X 40 MM SUPERA STENT AND IT COULD NOT RELEASE FROM THE 6F SHEATH SO THE SHEATH AND STENT WERE REMOVED FROM THE ANATOMY TOGETHER. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6108158 ↗
• InjuryAug 29, 2016Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT A TARGET LESION IN THE RIGHT EXTERNAL ILIAC INTO THE COMMON FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED AND THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY. THE SUPERA STENT WAS DEPLOYED AND UPON REMOVAL OF THE STENT DELIVERY SYSTEM, IT WAS NOTED THAT THE TIP REMAINED IN THE PATIENT ANATOMY. A NON-ABBOTT COVERED STENT WAS USED TO TRAP THE TIP TO THE VESSEL WALL IN THE RIGHT COMMON FEMORAL ARTERY. THE LOCATION OF THE SEPARATED TIP WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 5911157 ↗
• InjuryAug 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, ONE SUPERA STENT WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT HAD CALF PAIN AND IN-STENT RESTENOSIS ON (B)(6) 2016. LASER ATHERECTOMY AND BALLOON ANGIOPLASTY WERE PERFORMED. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Stenosis

  MAUDE report 5880541 ↗
• InjuryAug 8, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY. A 5.5 X 40 MM SUPERA STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2016 THE PATIENT RETURNED WITH THE STENT OCCLUDED. THE OCCLUSION WAS TREATED WITH ATHERECTOMY, LASER AND A BALLOON CATHETER. THE PATIENT IS DOING WELL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Occlusion

  MAUDE report 5855110 ↗