SUPERA S-55-100-120-P6 (UDI 08975370026313)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08975370026313), received between Aug 2, 2016 and Mar 2, 2018 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2018Device Difficult to Setup or Prepare; Device Contamination with Chemical or Other Material; Physical Property Issue

  IT WAS REPORTED THAT THE FLUSH PORT OF THE SUPERA DELIVERY CATHETER WAS SHORTER, DID NOT HAVE THREADING, AND WAS A MILKY, WHITE COLOR. THIS DEVICE WAS NOT USED IN THE BODY. ANOTHER SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE ANALYSIS IDENTIFIED A WHITE SUBSTANCE INSIDE THE FLUSH PORT OF THE RETURNED DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7310970 ↗
• MalfunctionAug 10, 2017Positioning Failure

  IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION, A 5.0 X 120 MM SUPERA STENT WAS DEPLOYED IN THE MID POPLITEAL ARTERY WITHOUT INCIDENT. A 5.5 X 100 MM SUPERA STENT WAS THEN ADVANCED AND DEPLOYED IN THE PREDILATED, MODERATELY CALCIFIED, NON-TORTUOUS, RIGHT SUPERFICIAL FEMORAL ARTERY. AFTER THE STENT DELIVERY SYSTEM AND THE SHEATH WERE REMOVED FROM THE ANATOMY, MANUAL PRESSURE WAS APPLIED ON THE GROIN ACCESS SITE WHEN IT WAS NOTED THAT APPROXIMATELY 1 CM OF THE SUPERA STENT WAS STICKING OUT OF THE LEFT GROIN. THE SUPERA STENT WAS MANUALLY REMOVED FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787135 ↗
• MalfunctionMar 29, 2017Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. THE LESION WAS PRE-DILATED WITH A 5.5 BALLOON DILATATION CATHETER (BDC). THE 5.5X100MM SUPERA PERIPHERAL STENT WAS IMPLANTED WITHOUT ISSUES; HOWEVER, AFTER REVIEW WITH FLURO IT WAS DECIDED TO POST-DILATE THE STENT. THE SAME 5.5 BDC WAS ADVANCED FOR POST-DILATATION AND UPON REMOVAL IT WAS NOTICED THAT THE 5.5X100MM SUPERA STENT WAS ON THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 5.5X100MM SUPERA PERIPHERAL STENT. 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 6444270 ↗
• InjuryMar 20, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT WITH A HISTORY OF CLAUDICATION WAS TREATED FOR A DISSECTION IN THE RIGHT MID POPLITEAL ARTERY WITH THE IMPLANTATION OF A 5.5 X 100 MM SUPERA STENT. ON (B)(6) 2017 THE PATIENT COMPLAINED OF CALF CLAUDICATION AFTER WALKING 30 TO 50 YARDS. AN ARTERIAL DUPLEX SCAN (ADS) CONFIRMED ELEVATED VELOCITY INDICATING A NARROWING IN STENT CAUSED BY STENOSIS. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WITH RUNOFF WAS ORDERED AND THE PATIENT WAS ADVISED TO CONTINUE A REGIMEN OF ASPIRIN AND PLAVIX. THE PATIENT CHOSE TO HAVE INTERVENTION DONE AT ANOTHER HEALTHCARE FACILITY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Stenosis

  MAUDE report 6419308 ↗
• InjurySep 21, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A SUPERA STENT WAS SUCCESSFULLY IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2016, THE PATIENT PRESENTED WITH LEG PAIN. ON (B)(6) 2016, A DIAGNOSTIC ANGIOGRAM WAS PERFORMED REVEALING 90% PROXIMAL AND 50% MID STENT RESTENOSIS. THE PATIENT HAD ANGIOPLASTY TREATMENT WITH A GOOD OUTCOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 5968024 ↗
• MalfunctionAug 2, 2016Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE NON-TORTUOUS, MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE 5.5 X 100 SUPERA STENT WAS ADVANCED AND DEPLOYED IN THE LESION WITHOUT ISSUE; HOWEVER, RESISTANCE WAS FELT DURING RETRACTION OF THE 5.5 X 100 MM SUPERA STENT DELIVERY SYSTEM BELIEVED TO BE DUE TO A KINK IN THE NON-ABBOTT GUIDE WIRE. 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 5841196 ↗