Fluency® Endovascular Stent Graft FEM14100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049519008714), received between Oct 14, 2015 and Jul 25, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (5 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.

• MalfunctionJul 25, 2024Positioning Failure; Retraction Problem; Misfire; Positioning Failure; Retraction Problem; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT UPPER EXTREMITY BRACHIOCEPHALIC ARTERIOVENOUS FISTULA, THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE THE SHEATH WAS PULLED BACK FOR ONLY ABOUT FIVE MILLIMETERS AND IT ALLEGEDLY GOT STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824508 ↗
• MalfunctionSep 21, 2021Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH THE LEFT ARM FISTULA THROUGH A TORTUOUS PATHWAY, THE STENT ALLEGEDLY WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505254 ↗
• MalfunctionJul 15, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14100 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276625 ↗
• MalfunctionOct 29, 2018Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT THE STENT GRAFT ALLEGEDLY DEPLOYED ABOUT 3-5% AND THEN WOULD NOT DEPLOY ANY FURTHER IN A SLIGHTLY TORTUOUS MID-FOREARM LESION. THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT. REPORTEDLY, 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 8016406 ↗
• MalfunctionOct 14, 2015Positioning Failure; Material Perforation

  IT WAS REPORTED THAT DURING PLACEMENT IN THE CANNULATION ZONE OF AN A/V GRAFT, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THE DELIVERY SYSTEM WAS RETRACTED WITHOUT DIFFICULTIES. 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 5149451 ↗