Fluency® Endovascular Stent Graft FEM09060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04049519008547), received between Feb 26, 2018 and May 25, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY APPEARED TO EXCESS AFTER SEATING THE STENT. IT WAS FURTHER REPORTED THAT DEVICE CAUSED EXTRAVASATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extravasation

  MAUDE report 14494854 ↗
• InjuryMay 24, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE TO TREAT A CLOTTED ACCESS IN THE LEFT UPPER ARM FISTULA, THE DEPLOYED STENT GRAFT ALLEGEDLY LED TO AN EXTRAVASATION OF THE SURROUNDING VESSEL. THE DEVICE WAS REMAINED IN THE PATIENTS VESSEL AND AN ADDITIONAL DEVICE WAS USED TO STOP THE EXTRAVASATION. PATIENT HAS NO POST-PROCEDURAL ISSUES.

  Patient problems: Extravasation; Rupture

  MAUDE report 14489664 ↗
• MalfunctionApr 9, 2020Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL FEM09060 ENDOVASCULAR STENT GRAFT EXPERIENCED A POSITIONING FAILURE AND MATERIAL PERFORATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE 62 YEAR OLD FEMALE PATIENT WEIGHED 232 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943869 ↗
• MalfunctionMar 5, 2019Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A RIGHT ARM A/V FISTULA PROCEDURE THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT AND ANOTHER SAME SIZE ENDOVASCULAR STENT GRAFT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8392703 ↗
• MalfunctionMar 6, 2018Material Invagination; Misfire; Material Invagination; Misfire

  IT WAS REPORTED THAT THE STENT ALLEGEDLY PARTIALLY DEPLOYED; THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7318908 ↗
• MalfunctionFeb 26, 2018Hole In Material; Hole In Material

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT WAS IDENTIFIED WITH AN ALLEGED HOLE IN THE STENT GRAFT COVERING RESULTING IN CLOT BEHIND AND INSIDE THE STENT GRAFT. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER USED TPA TO DISSOLVE THE CLOT AND USED ANOTHER ENDOVASCULAR STENT GRAFT IN AN OVERLAP TECHNIQUE PLACING IT PROXIMALLY TO COVER THE HOLE AND COMPLETING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297656 ↗