SUPERA S-65-060-120-P6 (UDI 08975370026351)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08975370026351), received between Sep 25, 2016 and Jul 24, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUSLY IMPLANTED UNSPECIFIED STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) THAT WAS FRACTURED. AN UNSPECIFIED BALLOON CATHETER WAS INSERTED INTO THE FRACTURED STENT AND INFLATED SEVERAL TIMES TO OPEN IT UP. A 6.50 X 60 MM SUPERA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS SUCCESSFULLY DEPLOYED INSIDE THE PREVIOUSLY IMPLANTED STENT TO COVER THE FRACTURE. UPON REMOVAL OF THE SUPERA SDS FROM THE ANATOMY WITH NO RESISTANCE FELT, IT WAS OBSERVED THAT THE TIP HAD SEPARATED AND WAS LOCATED INSIDE THE SHEATH. A SNARE DEVICE WAS USED SUCCESSFULLY SNARE THE SEPARATED TIP AND REMOVE IT FROM THE ANATOMY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6736226 ↗
• InjurySep 25, 2016Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE PERONEAL ARTERY. A SUPERA STENT WAS ADVANCED TOWARD THE TARGET LESION AND THE STENT WAS IMPLANTED. POST DILATATION WAS PERFORMED DUE TO STENT MAL-APPOSITION. ADDITIONAL TREATMENT WAS REQUIRED DUE TO A PERFORATION CAUSED BY A NON-ABBOTT GUIDE WIRE IN THE LEFT PERONEAL ARTERY. TWO UNSUCCESSFUL ATTEMPTS WERE MADE TO SEAL A PERFORATION BY INFLATING A BALLOON. A 3.5X19MM GRAFTMASTER STENT SYSTEM WAS ADVANCED TOWARD THE TARGET LESION. THE SYSTEM WAS INFLATED UP TO 12 ATMOSPHERES, THE STENT WAS IMPLANTED AND THE PERFORATION WAS SUCCESSFULLY SEALED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5976132 ↗