Fluency® Endovascular Stent Graft FEM06120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008424), received between May 30, 2016 and May 30, 2016 — classified as 2 malfunctions.

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

• MalfunctionMay 30, 2016Positioning Failure; Fracture; Fracture

  IT WAS REPORTED THAT DURING STENTING OF THE RADIAL ARTERY VIA ACCESS THROUGH AN UPPER ARM FISTULA, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING PARTIALLY RELEASED. FURTHERMORE, A BREAKAGE OF THE SHEATH OF THE DELIVERY SYSTEM WAS NOTICED. THE DEVICE WAS REMOVED AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00141.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5687645 ↗
• MalfunctionMay 30, 2016Positioning Failure; Fracture; Fracture

  IT WAS REPORTED THAT DURING STENTING OF THE RADIAL ARTERY VIA ACCESS THROUGH AN UPPER ARM FISTULA, THE ENDOVASCULAR STENT GRAFT FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT A BREAKAGE OF THE DELIVERY SYSTEM SHEATH WAS NOTICED. THE DELIVERY SYSTEM WAS REMOVED AND EXCHANGED BY A DEVICE OF THE SAME BRAND AND SIZE WHICH ALSO FAILED TO DEPLOY. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00142.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5687642 ↗