Fluency® Endovascular Stent Graft FEM07120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519008479), received between Apr 13, 2016 and Nov 30, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Positioning Failure; Fracture; Misfire; Detachment of Device or Device Component; Positioning Failure; Fracture; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE IN THE LEFT A/V GRAFT, THE DELIVERY SYSTEM ALLEGEDLY JAMMED AND BROKE CAUSING THE STENT GRAFT FAILURE TO DEPLOY ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892976 ↗
• MalfunctionApr 14, 2020Fracture; Misfire; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM07120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FRACTURE AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959685 ↗
• MalfunctionMar 21, 2018Positioning Failure; Misfire; Malposition of Device; Positioning Failure; Misfire; Malposition of Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR STENT GRAFT PROCEDURE IN THE AXILLARY VEIN, THE STENT GRAFT ALLEGEDLY JUMPED 6MM AND THEN PARTIALLY DEPLOYED AT THE TREATMENT SITE. IT WAS FURTHER REPORTED THAT THE HAND GRIP DETACHED AFTER THE STENT GRAFT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT, AND A SECOND ENDOVASCULAR STENT GRAFT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357597 ↗
• MalfunctionApr 13, 2016Positioning Failure; Fracture; Fracture

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED DURING STENTING OF AN A/V FISTULA IN THE ARM. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5572903 ↗