Fluency® Endovascular Stent Graft FEM07100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008462), received between Feb 8, 2017 and Jul 5, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionJul 5, 2017Fracture; Malposition of Device; Fracture; Malposition of Device

  IT WAS REPORTED THAT DURING DEPLOYMENT IN THE LEFT FOREARM IN THE CEPHALIC VEIN, CLOSE TO THE ELBOW, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY JUMPED AND THE STENT DEPLOYED RELATIVELY CLOSE TO THE INTENDED PLACEMENT SITE. THEREFORE, THE HEALTH CARE PROVIDER DECIDED TO LEAVE THE STENT IN PLACE. REPORTEDLY, ANOTHER STENT GRAFT WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6687125 ↗
• MalfunctionFeb 8, 2017Material Invagination; Failure to Advance; Material Invagination; Failure to Advance

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT SHOULD BE PLACED IN THE UPPER ARM DURING A FISTULOGRAM PROCEDURE. DURING SHEATHLESS INSERTION OF THE STENT DELIVERY SYSTEM, RESISTANCE WAS FELT AND THE DEVICE COULD NOT BE ADVANCED OVER THE GUIDE WIRE TO THE LESION SITE THROUGH THE TRACKING ANATOMY. ANOTHER STENT GRAFT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6311862 ↗