Fluency® Endovascular Stent Graft FEM12100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519008660), received between May 11, 2017 and Jun 12, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Break; Malposition of Device; Detachment of Device or Device Component; Break; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR A DISEASED ACCESS SITE SEGMENT THROUGH THE ARTERIAL LIMB OF A THIGH LOOP GRAFT, THE STENT ALLEGEDLY JUMPED MISSING THE TARGET LESION. IT WAS FURTHER REPORTED THAT THE CATHETER TIP ALLEGEDLY BROKE OFF IN THE VESSED DURING DEPLOYMENT. REPORTEDLY, THE BROKEN VISIBLE MARKER WAS CAPTURED AGAINST THE WALL OF THE GRAFT BY USING ANOTHER STENT. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19516851 ↗
• InjuryJan 11, 2024Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT FOREARM, A FOREIGN BODY WAS ALLEGEDLY FOUND UNDER X-RAY EXAMINATION. REPORTEDLY, THE PATIENT HAD TO HAVE THE VEIN REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18490671 ↗
• MalfunctionOct 14, 2019Break; Positioning Failure; Detachment of Device or Device Component; Break; Positioning Failure; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12100, ENDOVASCULAR STENT GRAFT, ALLEGEDLY FAILED TO DEPLOY, EXPERIENCED A BREAK, DETACHMENT, AND A DEVICE-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S WEIGHT, AGE, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188965 ↗
• MalfunctionMay 11, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF A LEFT ARM FISTULA, RESISTANCE WAS MET AND THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. ANOTHER STENT WAS USED TO CONTINUE THE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559622 ↗