Fluency® Endovascular Stent Graft FEM10040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04049519008585), received between Sep 26, 2017 and Jul 7, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR ARTERIOVENOUS FISTULA STENOSIS, THE STENT ALLEGEDLY JUMPED AND FELT LIKE IT WAS STICKING TO THE SHAFT AND NOT DEPLOYING AS SMOOTHLY AS USUAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280501 ↗
• MalfunctionOct 14, 2019Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES MODEL FEM10040, ENDOVASCULAR STENT GRAFT, ALLEGEDLY FAILED TO DEPLOY AND MISFIRED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A (B)(6) YEAR OLD MALE WEIGHING 130 POUNDS, THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188648 ↗
• MalfunctionJul 18, 2019Difficult to Remove; Material Perforation; Misfire; Difficult to Remove; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A MATERIAL PERFORATION AND A MISFIRE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED A MATERIAL PERFORATION AND MISFIRE INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT IS A (B)(6) -YEAR-OLD MALE; WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805694 ↗
• MalfunctionJul 18, 2019Malposition of Device; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT MODEL FEM10040 ENDOVASCULAR STENT GRAFT EXPERIENCED MALPOSITIONING OF DEVICE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT. THE PATIENT IS A (B)(6) YEAR-OLD MALE, OF (B)(6) LBS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803123 ↗
• MalfunctionOct 5, 2017Fracture; Material Invagination; Failure to Advance; Fracture; Material Invagination; Failure to Advance

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT IN AN UPPER ARM STENOSIS IN THE VEIN, THE HEALTH CARE PROVIDER ATTEMPTED TO DEPLOY THE STENT GRAFT WITHOUT AN INTRODUCER SHEATH, AND THE OUTER SHEATH OF THE DELIVERY SYSTEM ALLEGEDLY FRACTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6918901 ↗
• MalfunctionSep 26, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR STENT GRAFT PROCEDURE TO SEAL AN ANEURYSM IN THE LEFT ARM TRANSPOSED AV FISTULA; BASILICA VEIN, THE STENT GRAFT ALLEGEDLY JUMPED AND WAS IMPLANTED APPROXIMATELY 2CM FROM THE INTENDED PLACEMENT SITE. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT, AND A SECOND ENDOVASCULAR STENT GRAFT WAS DEPLOYED TO COMPLETELY SEAL THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6895022 ↗