Fluency® Endovascular Stent Graft FEM09040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049519008530), received between Mar 15, 2016 and Jun 6, 2017 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT MIGRATED UP TO THE ARM AFTER IT WAS POST-DILATED WITH A 9 X 4 BALLOON. AN ADDITIONAL STENT GRAFT WAS USED TO SECURE THE ENDOVASCULAR STENT GRAFT IN PLACE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6614672 ↗
• InjuryApr 10, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING PLACEMENT OF THE ENDOVASCULAR STENT GRAFT IN THE VENOUS OUTFLOW OF THE BASILIC VEIN, THE STENT DELIVERY SYSTEM WAS ADVANCED PAST THE LESION SITE AND THEN RETRACTED TO POSITION THE STENT GRAFT PROPERLY. UPON DEPLOYMENT, IT WAS NOTICED THAT A MAJORITY OF THE STENT GRAFT HAD ALREADY BEEN RELEASED. AFTER COMPLETION OF THE DEPLOYMENT, IT WAS NOTICED THAT THE STENT GRAFT WAS IMPROPERLY POSITIONED. ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6475441 ↗
• InjuryJan 4, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE STENT GRAFT MIGRATED INTO THE AXILLIARY VEIN RESULTING IN A SECOND STENT GRAFT DEPLOYMENT IN AN OVERLAPPING MANNER TO PREVENT FURTHER MOVEMENT. ANOTHER STENT GRAFT WAS PLACED INTO THE VENOUS ANASTOMOSIS TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Vascular System (Circulation), Impaired

  MAUDE report 6221054 ↗
• MalfunctionSep 27, 2016Positioning Failure; Fracture; Detachment of Device or Device Component; Positioning Failure; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED AT THE TARGET SITE DUE TO RESISTANCE RESULTING IN THE BREAKAGE OF THE DELIVERY SYSTEM CATHETER. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ANY ISSUES 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 5980079 ↗
• MalfunctionMar 15, 2016Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED IN THE ARTERIAL END OF AN A/V FISTULA. ANOTHER ENDOVASCULAR 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 5499960 ↗