Fluency® Endovascular Stent Graft FEL06120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519008073), received between May 31, 2016 and May 31, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2016Break; Positioning Failure; Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT DURING A SHEATHLESS STENTING PROCEDURE OF THE RIGHT MID TO DISTAL TORTUOUS AND/OR CALCIFIED SFA VIA LEFT CFA ACCESS, THE ENDOVASCULAR STENT GRAFT FAILED TO DEPLOY PROPERLY. REPORTEDLY, THE SHEATH OF THE DELIVERY SYSTEM SNAPPED IN HALF WHEN THE DISTAL 3RD OF THE STENT GRAFT WAS BEING PARTIALLY RELEASED WITH DIFFICULTY. THE STENT GRAFT WAS REMOVED THROUGH THE PUNCTURE SITE LEADING TO A BLEEDING COMPLICATION, A HEMATOMA OF THE LEFT GROIN AND THIGH AS WELL AS A SECOND ANGIOGRAM TO TREAT THE BLEEDING AND ACHIEVE HEMOSTASIS. AS REPORTED, NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5688674 ↗