Fluency® Endovascular Stent Graft FEM09100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049519008561), received between May 18, 2016 and Dec 4, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

• MalfunctionDec 4, 2025Misfire; Misfire

  A PATIENT UNDERWENT STENT GRAFT PLACEMENT PROCEDURE USING FLUENCY STENT GRAFT. DURING PROCEDURE, THE STENT PARTIAL DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714961 ↗
• MalfunctionOct 15, 2019Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM09100. ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, MISFIRE, AND FRACTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS 66 YEARS OLD, MALE AND 59KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192287 ↗
• MalfunctionNov 1, 2017Fracture; Use of Device Problem; Device Damaged by Another Device; Fracture; Use of Device Problem; Device Damaged by Another Device

  IT WAS REPORTED THAT A STENT GRAFT WAS SUCCESSFULLY PLACED IN THE BASILIC VEIN. APPROXIMATELY ONE MONTH AFTER STENT GRAFT PLACEMENT DURING DIALYSIS TREATMENT. THE DIALYSIS NEEDLE HAD CAUGHT ONTO THE STENT DURING RETRACTION OF THE NEEDLES, AND ALLEGEDLY PULLED OUT A FRAGMENT OF THE STENT GRAFT THROUGH THE BASILIC VEIN AND THE PATIENT'S SKIN. REPORTEDLY, THE ACCESS SITE WAS TIGHT AND THERE WAS RESISTANCE DURING REMOVAL OF THE NEEDLES AND STENT FRAGMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6994237 ↗
• MalfunctionOct 3, 2017Positioning Failure; Fracture; Material Perforation; Positioning Failure; Fracture; Material Perforation

  IT WAS REPORTED THAT DURING DEPLOYMENT, USING THE PIN AND PULL PROCESS, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY ONLY PARTIALLY DEPLOYED AS THERE WAS NO MORE ROOM BETWEEN THE CATHETER AND THE HANDLE TO CONTINUE WITH THE PIN & PULL ACTION IN ORDER TO FULLY DEPLOY THE STENT GRAFT. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED WITH THE PARTIAL DEPLOYED STENT WITHOUT INCIDENT. REPORTEDLY, ANOTHER DELIVERY SYSTEM WAS USED IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6909466 ↗
• MalfunctionMay 18, 2016Positioning Failure; Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. ANOTHER ENDOVASCULAR STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO COMPLICATIONS WERE CAUSED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 5665292 ↗