Fluency® Endovascular Stent Graft FEM08080Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04049519008509), received between Nov 11, 2015 and Mar 24, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Break; Break

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, THE PLASTIC PIECE BROKE OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610596 ↗
• MalfunctionOct 21, 2022Positioning Failure; Detachment of Device or Device Component; Material Deformation; Positioning Failure; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649124 ↗
• MalfunctionApr 8, 2020Break; Fracture; Break; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE MALFUNCTION WAS REVIEWED AND INDICATED THAT MODEL FEM08080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A FRACTURE AND A BREAK. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE 53 YEAR OLD MALE PATIENTS WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941564 ↗
• MalfunctionMay 30, 2018Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE INTENDED FOR AN ANEURYSM OF A LEFT FOREARM LOOP GRAFT, THE STENT ALLEGEDLY FAILED TO DEPLOY. REPORTEDLY, THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553634 ↗
• MalfunctionApr 9, 2018Positioning Failure; Fracture; Detachment of Device or Device Component; Positioning Failure; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT AT THE VENOUS ANASTAMOSIS IN A LEFT ARM FISTULA, THE OUTER SHEATH ALLEGEDLY BROKE AND THE STENT GRAFT WOULD NOT DEPLOY. IT WAS FURTHER REPORTED THAT THE STENT GRAFT DELIVERY SYSTEM WAS REMOVED AND EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7410202 ↗
• MalfunctionMar 27, 2018Material Rupture; Material Rupture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374396 ↗
• MalfunctionMay 11, 2017Positioning Failure; Fracture; Material Perforation; Positioning Failure; Fracture; Material Perforation

  IT WAS REPORTED THAT DURING AN ATTEMPT TO DEPLOY THE ENDOVASCULAR STENT GRAFT IN THE CEPHALIC ARCH VIA ACCESS THROUGH THE LEFT UPPER ARM, THE SHEATH OF THE DELIVERY SYSTEM RUPTURED AND THE STENT GRAFT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559627 ↗
• MalfunctionApr 25, 2017Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING STENT GRAFT PLACEMENT FOR TREATMENT OF A RUPTURED VESSEL IN THE BRACHIOCEPHALIC VIA ACCESS THROUGH THE LEFT UPPER ARM, THE SLEEVE OF THE INTRODUCER RUPTURED. ANOTHER STENT GRAFT OF THE SAME BRAND AND SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6519028 ↗
• MalfunctionApr 10, 2017Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT FOR TREATMENT OF A PRE-DILATED STENOSIS IN THE OUTFLOW OF AN A/V FOREARM GRAFT VIA ACCESS THROUGH THE FOREARM, RESISTANCE WAS MET AND THE OUTER CATHETER OF THE DELIVERY SYSTEM BROKE NEAR THE HANDLE. THE STENT GRAFT COULD NOT BE DEPLOYED. REPORTEDLY, THERE WAS NO DIFFICULTY IN ADVANCING THE SYSTEM TO OR RETRACTING IT FROM THE TREATMENT SITE BUT FORCE WAS USED TO GO AROUND THE LOOP OF THE FOREARM LOOP GRAFT. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT AND 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 6476310 ↗
• MalfunctionApr 3, 2017Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT IN THE LEFT CEPHALIC VEIN VIA ACCESS THROUGH THE LEFT BRACHIOCEPHALIC VEIN, THE OUTER CATHETER BROKE WHEN THE STENT GRAFT WAS BEING DEPLOYED APPROXIMATELY HALFWAY. THE DELIVERY SYSTEM WITH THE PARTIALLY RELEASED STENT WAS REMOVED WITHOUT INCIDENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6453542 ↗
• MalfunctionMar 21, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT FAILED TO DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6421829 ↗
• MalfunctionFeb 9, 2017Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. REPORTEDLY, AN UNDERSIZED INTRODUCER SHEATH WAS USED DURING THE PROCEDURE RESULTING IN THE DEPLOYMENT FAILURE. ANOTHER DEVICE OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6314551 ↗
• MalfunctionDec 15, 2016Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING TREATMENT IN A VENOUS ANASTOMOSIS VIA A LEFT UPPER ARM BRACHIAL BASILIC GRAFT, THE STENT GRAFT FAILED TO DEPLOY AND THE OUTER SHEATH FRACTURED. THE SYSTEM WAS REMOVED AND ANOTHER DEVICE FROM THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6177396 ↗
• InjuryMay 18, 2016Difficult or Delayed Positioning; Positioning Failure; Difficult to Remove; Stretched; Positioning Problem; Difficult or Delayed Positioning; Difficult to Remove

  IT WAS REPORTED THAT DURING PLACEMENT OF THE ENDOVASCULAR STENT GRAFT IN THE CEPHALIC VEIN VIA ACCESS THROUGH A LEFT UPPER ARM A/V GRAFT FOR TREATMENT OF A REOCCURRING LESION WITH A 30 % RESIDUAL STENOSIS AFTER BALLOON DILATION, THE STENT GRAFT COULD NOT BE DEPLOYED. REPORTEDLY, THE ANATOMY OF THE TRACKING VESSEL WAS TORTUOUS AND THE PROXIMAL END OF THE STENT GRAFT WAS PLACED IN A CORNER. DURING RETRACTION OF THE DELIVERY SYSTEM, DIFFICULTIES OCCURRED AND THE SHAFT APPEARED TO BE STRETCHING. REPORTEDLY, THE ENTIRE SYSTEM WAS REMOVED. NO OTHER STENT WAS PLACED THIS DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5665291 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED DURING A STENTING OF A LEFT FOREARM GRAFT. THE DEVICE WAS RETRACTED WITHOUT ISSUE AND 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 5217206 ↗