Fluency® Endovascular Stent Graft FEM10100Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04049519008615), received between Aug 4, 2017 and Nov 28, 2024 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Misfire” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2024Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804476 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE VENOUS ANASTOMOSIS/AXILLARY VEIN, THE STENT ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618089 ↗
• MalfunctionDec 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEPLOYMENT PIECE ALLEGEDLY SNAPPED OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290628 ↗
• MalfunctionSep 12, 2023Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN LEFT UPPER ARM CEPHALIC ARCH TO TREAT SOME RESIDUAL STENOSIS, THE STENT GRAFT 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 17727801 ↗
• MalfunctionAug 11, 2023Fracture; Misfire; Material Deformation; Fracture; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA THE LEFT UPPER EXTREMITY ARTERIOVENOUS GRAFT, STENT GRAFT ALLEGEDLY WOULDN'T FULLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY STRETCHED. REPORTEDLY STENT ALLEGEDLY SPLIT IN HALF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17507896 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT HANDLE ALLEGEDLY BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13007727 ↗
• MalfunctionJan 13, 2020Misfire; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10100 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED PARTIAL DEPLOYMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE PARTIAL DEPLOYMENT MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. PATIENT'S AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583851 ↗
• MalfunctionJan 9, 2020Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10100. ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, MISFIRE, AND FRACTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS MALE, 90 KGS AND 73 YEARS OF AGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571297 ↗
• InjuryNov 21, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AFTER A STENT GRAFT PLACEMENT IN A LEFT UPPER ARM FISTULA, THE STENT GRAFT ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED AND AN ADDITIONAL DECLOT PROCEDURE WAS REQUIRED TO RESTORE PATENCY. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Occlusion

  MAUDE report 9357041 ↗
• MalfunctionJan 30, 2019Difficult to Remove; Retraction Problem; Misfire; Difficult to Remove; Retraction Problem; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE TO TREAT STENOSIS IN A FOREARM LOOP GRAFT, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE, THEREFORE THE SHEATH AND DELIVERY SYSTEM WERE REMOVED AS ONE UNIT. FURTHERMORE, UPON REMOVAL, THE PATIENT'S BLOOD PRESSURE DROPPED AND BECAME UNRESPONSIVE. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AND IS CURRENTLY STABLE.

  Patient problems: Lethargy; Low Blood Pressure/ Hypotension; Pain

  MAUDE report 8291010 ↗
• MalfunctionNov 6, 2018Material Deformation; Material Deformation

  IT WAS REPORTED DURING STENT GRAFT PLACEMENT TO COVER ANOTHER STENT, THE STENT GRAFT WAS ALLEGEDLY FOUND TO BE SHORTER THAN LABELED AND WAS UNABLE TO COVER THE ENDS. NO FURTHER TREATMENT WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8044284 ↗
• MalfunctionOct 24, 2018Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE OF THE BRACHIAL VEIN VIA FOREARM GRAFT ACCESS SITE, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8003033 ↗
• MalfunctionOct 11, 2018Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING TREATMENT FOR STENOSIS IN ILIAC GRAFT, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY EVEN AFTER APPLYING FORCE. REPORTEDLY, THE DEVICE WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. ANOTHER ENDOVASCULAR STENT GRAFT CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958614 ↗
• MalfunctionOct 9, 2018Break; Fracture; Misfire; Break; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE FOR TREATMENT OF VENOUS ANASTOMOSIS OF A PTFE GRAFT TO THE BASILIC VEIN USING A BAREBACK METHOD, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM WAS ALLEGEDLY BROKEN. 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 7947759 ↗
• MalfunctionAug 9, 2018Break; Positioning Failure; Misfire; Detachment of Device or Device Component; Break; Positioning Failure; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT ALLEGEDLY THE HUB OF THE HANDLE ALLEGEDLY BROKE DURING AN ATTEMPT TO DEPLOY THE STENT GRAFT. REPORTEDLY, THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT, AND ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7770731 ↗
• MalfunctionJan 31, 2018Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  IT WAS REPORTED THAT A STENT GRAFT WAS DEPLOYED TO COVER UP AN EXTRAVASATION AND THE STENT GRAFT COVERED THE PERFORATION. HOWEVER, AN ALLEGED LEAK WAS STILL IDENTIFIED AT THE PERFORATION SITE. IT WAS ALLEGED BY THE CUSTOMER THAT THERE WAS A TEAR IN THE COATING IN THE MIDDLE OF THE STENT GRAFT ALLOWING THE EXTRAVASATION TO CONTINUE. IT WAS FURTHER REPORTED THAT ANOTHER STENT GRAFT WAS DEPLOYED INSIDE THE PREVIOUS STENT GRAFT, OVERLAPPING TECHNIQUE, AND RESOLVED THE PERFORATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extravasation

  MAUDE report 7230913 ↗
• MalfunctionDec 20, 2017Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE INTENDED FOR THE STENOSIS IN THE OUTFLOW VEIN OF THE FISTULA, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY 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 7135622 ↗
• MalfunctionOct 6, 2017Fracture; Difficult to Remove; Difficult to Advance; Fracture; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE AT THE VENOUS ANASTOMOSIS ON LEG GRAFT, THE STENT GRAFT WAS ALLEGEDLY DIFFICULT TO ADVANCE INTO THE SHEATH. REPORTEDLY, AFTER THE STENT GRAFT WAS DEPLOYED, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE OUT OF THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6925829 ↗
• MalfunctionAug 4, 2017Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE FOR A LEFT ARM FISTULOGRAM TO TREAT IN-STENT RESTENOSIS IN THE BASILICA VEIN, THE ENDOVASCULAR STENT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM WAS USED AND THE PROCEDURE WAS COMPLETED. THE PATIENT IS REPORTEDLY DOING WELL AND HAS A FUNCTIONAL ACCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6769340 ↗