Fluency® Endovascular Stent Graft FEM08100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04049519008516), received between Sep 27, 2016 and Apr 6, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Break; Fracture; Difficult to Remove; Misfire; Break; Fracture; Difficult to Remove; Misfire

  IT WAS REPORTED THAT DURING TREATMENT OF A LEFT ARM STENT GRAFT CANNULATION ZONE AREA, THE BLUE PORTION OF THE CATHETER CLOSEST TO DEPLOYMENT TUOHY BROKE. IT WAS FURTHER REPORTED THAT THE STENT COULD NOT BE DEPLOYED AND HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689903 ↗
• MalfunctionMar 3, 2023Misfire; Malposition of Device; Detachment of Device or Device Component; Misfire; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE FOR THE LEFT UPPER ARM LOOP GRAFT REPAIR OF ENLARGING ANEURYSM. THE STENT ALLEGEDLY PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478590 ↗
• MalfunctionOct 17, 2022Positioning Failure; Misfire; Difficult to Advance; Positioning Failure; Misfire; Difficult to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613714 ↗
• MalfunctionJan 9, 2020Break; Positioning Failure; Fracture; Detachment of Device or Device Component; Break; Positioning Failure; Fracture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM08100 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A BREAK, FAILURE TO DEPLOY, AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCE. THE PATIENT WAS REPORTED AS A (B)(6) MALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570385 ↗
• MalfunctionJul 11, 2019Positioning Failure; Fracture; Material Perforation; Positioning Failure; Fracture; Material Perforation

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM08100 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, A FRACTURE, AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783335 ↗
• MalfunctionDec 4, 2018Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED DURING STENT GRAFT DEPLOYMENT IN CEPHALIC ARCH, THE STENT GRAFT ALLEGEDLY DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131180 ↗
• MalfunctionOct 31, 2018Fracture; Difficult to Remove; Misfire; Fracture; Difficult to Remove; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE TO DECLOT THE AVF USING A BAREBACK APPROACH, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED AND THE SHAFT ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE STENT GRAFT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026116 ↗
• MalfunctionJun 1, 2017Difficult or Delayed Positioning; Fracture; Malposition of Device; Difficult or Delayed Positioning; Fracture; Malposition of Device

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE STENT GRAFT FOR TREATMENT OF A PRE-DILATED THROMBOSIS OF AN EXTRAVASATION OF AN OUTFLOW VEIN OF 100 MM LENGTH ACROSS A TIGHT BEND VIA ACCESS THROUGH THE LEFT UPPER ARM, THE STENT GRAFT COULD NOT BE RELEASED ANY FURTHER AFTER BEING DEPLOYED 3/4 AND GOT STUCK INSIDE THE DELIVERY SYSTEM. DURING THE ATTEMPT TO DEPLOY THE STENT GRAFT, THE SHEATH OF THE DELIVERY SYSTEM BROKE. FINALLY, THE STENT GRAFT COULD BE DEPLOYED BUT WAS NOT IN THE CORRECT POSITION. TWO ADDITIONAL STENT GRAFTS WERE REQUIRED TO BE PLACED; ONE STENT WAS USED TO RE-STENT THE FRONT END TO COVER THE TARGET AREA AND ANOTHER STENT WAS IMPLANTED TO COVER THE BACK END OF THE STENT GRAFT WHICH WAS IN THE WRONG POSITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6606406 ↗
• MalfunctionSep 27, 2016Material Invagination; Failure to Advance; Detachment of Device or Device Component; Material Invagination; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE ATTEMPT TO LOAD THE STENT DELIVERY SYSTEM ONTO A 0.035" GUIDE WIRE PRIOR TO THE PROCEDURE, THE OUTER TIP OF THE DELIVERY SYSTEM BECAME DETACHED. REPORTEDLY, THE BLUE PORTION OF THE CATHETER WAS NOTICEABLE. ANOTHER STENT GRAFT WAS USED WITH THE SAME GUIDE WIRE TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5980142 ↗