Fluency® Endovascular Stent Graft FEL10120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049519008271), received between Oct 6, 2017 and Sep 20, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Misfire” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2018Positioning Failure; Difficult to Remove; Misfire; Positioning Problem; Positioning Failure; Difficult to Remove; Misfire; Positioning Problem

  IT WAS REPORTED THAT AFTER MULTIPLE ATTEMPTS, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY IN THE LEFT COMMON ILIAC ARTERY VIA A RIGHT COMMON FEMORAL ARTERY ACCESS SITE. IT WAS FURTHER REPORTED THAT THERE WAS SOME DIFFICULTY ADVANCING THE DELIVERY SYSTEM TO AND RETRACTING THE DELIVERY SYSTEM FROM THE TARGET LESION. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895617 ↗
• MalfunctionOct 6, 2017Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING DEPLOYMENT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY ONLY PARTIALLY DEPLOYED AS THERE WAS NO MORE ROOM 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, TWO SMALLER SIZE STENT GRAFTS WERE SUCCESSFULLY DEPLOYED TO COVER THE TREATMENT AREA AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6925651 ↗
• MalfunctionOct 6, 2017Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING DEPLOYMENT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY ONLY PARTIALLY DEPLOYED, AS THERE WAS NO MORE ROOM TO CONTINUE WITH THE PIN AND 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 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6925630 ↗