Fluency® Endovascular Stent Graft FEM07080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04049519008455), received between Dec 17, 2015 and Oct 11, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2021Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605996 ↗
• MalfunctionJul 17, 2019Fracture; Misfire; Detachment of Device or Device Component; Fracture; Misfire; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM07080 ENDOVASCULAR STENT GRAFT ALLEGEDLY DETACHED, PARTIALLY DEPLOYED, AND FRACTURED PRIOR TO INSERTION IN THE PATIENT. THERE WAS NO PATIENT CONTACT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8798818 ↗
• MalfunctionMar 19, 2018Misfire; Misfire

  IT WAS REPORTED THAT DURING TREATMENT IN THE CEPHALIC VIA THE UPPER ARM, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED APPROXIMATELY 40MM. THE CATHETER DELIVERY SYSTEM WAS REPORTEDLY REMOVED WITHOUT INCIDENT FROM THE PATIENT. REPORTEDLY, THE DEVICE WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7351283 ↗
• MalfunctionFeb 5, 2018Positioning Failure; Fracture; Difficult to Advance; Positioning Failure; Fracture; Difficult to Advance

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR THE CEPHALIC ARCH, THE DEVICE WAS ALLEGEDLY DIFFICULT TO ADVANCE TO THE TARGET LESION. IT WAS FURTHER REPORTED THAT THE OUTER SHEATH OF THE DEVICE ALLEGEDLY FRACTURED DURING AN ATTEMPT TO DEPLOY THE STENT GRAFT. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND TWO NEW STENT GRAFTS WERE PLACED USING THE OVERLAPPING TECHNIQUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7241212 ↗
• MalfunctionOct 31, 2017Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE INTENDED FOR THE BASILIC VEIN, THE STENT ALLEGEDLY PARTIALLY DEPLOYED AND THE OUTER SHEATH OF THE DEVICE ALLEGEDLY FRACTURED. 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 6991035 ↗
• MalfunctionSep 6, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING TREATMENT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5928371 ↗
• MalfunctionDec 17, 2015Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED DURING A BAREBACK STENTING PROCEDURE. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5307249 ↗