Fluency® Endovascular Stent Graft FEM07040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008431), received between Sep 29, 2015 and Sep 18, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (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.

• MalfunctionSep 18, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT AFTER A SUCCESSFUL ENDOVASCULAR STENT GRAFT PLACEMENT PROCEDURE TO COVER A TIGHT STENOSIS, THE HEALTH CARE PROVIDER RAN A POST VISUAL IMAGE AND ALLEGED IT APPEARED THERE WAS A VESSEL DISSECTION AT THE DISTAL END OF THE STENT GRAFT. THEREFORE, A SECOND ENDOVASCULAR STENT GRAFT WAS PLACED TO COVER THE ALLEGED PERFORATION AND COMPLETE THE PROCEDURE. REPORTEDLY, HEMOSTASIS WAS ACHIEVED, AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 7887757 ↗
• MalfunctionSep 29, 2015Positioning Failure; Premature Activation

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE ENDOVASCULAR STENT GRAFT IN A LOWER ARM LOOP GRAFT, THE STENT GRAFT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING PARTIALLY RELEASED. THE DEVICE WAS RETRACTED WITHOUT ISSUE AND ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5110134 ↗