EverFlex™ EVD35-07-120-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821684051467), received between Sep 17, 2017 and Feb 15, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 reports).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (P110023); they may or may not involve this specific model.

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.

Recalls naming this device

1. Nov 3, 2017Class IITerminated

   Stent length on the label may not match the length of the stent itself.

   Z-0188-2018 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2024Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 5F NON-MEDTRONIC SHEATH AND A 035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS LEFT DISTAL EXTERNAL ILIAC/COMMON FEMORAL ARTERY. NO VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 75% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. A 5MM EVERCROSS WAS USED FOR PRE-DILATION. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN BROKE. IT WAS REPORTED THE STENT WAS UNABLE TO DEPLOY. STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT BROKE IN HALF AND WAS PARTIALLY EXPLANTED. A SECOND 7X80 EVERFLEX ENTRUST STENT WAS SUCCESSFULLY PLACED THROUGH THE BROKEN IMPLANTED STENT. THE OTHER HALF OF THE STENT WAS STILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710274 ↗
• MalfunctionSep 5, 2023Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 6FR SHEATH AND A 0.014 NON-MEDTRONIC (BOSTON - THRUWAY) GUIDEWIRE DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENTS LEFT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. ARTERY DIAMETER REPORTED AS 7MM. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 6MM PRE-DILATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED BEFORE DEPLOYMENT. WIRE MOVEMENT ISSUES ARE REPORTED. PHYSICIAN WAS UNABLE TO REMOVE DEVICE FROM GUIDEWIRE. THE STENT WAS STUCK ON WIRE AND WOULD NOT DEPLOY. WHEN PULLING EVERYTHING OUT AS A UNIT (WIRE AND STENT) THE STENT STARTED TO DEPLOY PROXIMAL TO TARGET. THE PHYSICIAN COMPLETED DEPLOYMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683042 ↗
• MalfunctionOct 18, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE PHYSICIAN HAD INTENDED TO USE AN EVERFLEX ENTRUST 7X120X120 TO TREAT A PLAQUE LESION IN THE LEFT PROXIMAL SFA. THE LESION WAS MODERATELY CALCIFIED AND HAD A LENGTH OF 100 MM. THE ARTERY WAS 6 MM AND HAD 80% STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT'S ANATOMY. THE PROCEDURE USED A 7 FR NON MEDTRONIC SHEATH AND A 0.035" GUIDE WIRE. THE EVERFLEX ENTRUST DEVICE WAS PREPPED AS PER THE IFU. THE PACKAGING OF THE DEVICE WAS FULLY INTACT. IT WAS NOTICED AFTER THE STENT ENTERED THE PATIENT THAT THE STENT WAS THE INCORRECT LENGTH. THIS WAS IDENTIFIED BY MEASURING USING FLUOROSCOPY AND THE MARKERS. THE STENT WAS REMOVED FROM THE BODY AND WAS NOT DEPLOYED. THE PROCEDURE WAS COMPLETED BY PRE-DILATING THE LESION WITH A SIZE 6 PRE-DILATION DEVICE AND USING A 7X100 EVERFLEX ENTRUST STENT. NO PATIENT INJURY WAS REPORTED. THE PHYSICIAN HAD INTENDED TO USE AN EVERFLEX STENT WITH ENTRUST DELIVERY SYSTEM, 7X120X120 TO TREAT A PLAQUE LESION IN THE LEFT PROXIMAL SFA. THE LESION WAS MODERATELY CALCIFIED AND HAD A LENGTH OF 100 MM. THE ARTERY WAS 6 MM AND HAD 80% STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT'S ANATOMY. THE PROCEDURE USED A 7 FR NON-MEDTRON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6960377 ↗
• InjuryOct 18, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX SELF-EXPANDING STENT WITH ENTRUST DELIVERY SYSTEM TO TREAT A 120 MM SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION IN THE RIGHT MID SFA. THE ARTERY WAS 6 MM IN DIAMETER. THE PROCEDURE UTILIZED A 6 FR NON-MEDTRONIC SHEATH AND A 0.035" WHOLEY GUIDEWIRE. NO EMBOLIC PROTECTION WAS USED. THE EVERFLEX ENTRUST WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED, NO ISSUES WERE NOTED TO THE PACKAGING. THE LESION WAS PRE-DILATED USING A 7 X 60 PRE-DILATION DEVICE. THE THUMBSCREW/ LOCK PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE AND THE LOCK PIN WAS REMOVED IMMEDIATELY BEFORE DEPLOYMENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT DURING POSITIONING/ DEPLOYMENT, STENT DEFORMATION OCCURRED. THE STENT BUNCHED UP ON DEPLOYMENT AND DID NOT DEPLOY CORRECTLY. WIRE ACCESS WAS LOST AND THE PHYSICIAN ATTEMPTED TO CROSS THE LESION SEVERAL TIMES WITH TWO NON-MEDTRONIC GUIDEWIRES AND A WHOLEY WIRE WITH NO SUCCESS. PATIENT WAS RECOMMENDED FOR A BYPASS SURGERY, BUT THAT WAS ABORTED AND AN AMPUTATION WAS NECESSARY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6960366 ↗
• MalfunctionSep 17, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE PHYSICIAN HAD INTENDED TO USE A 7X120 MM EVERFLEX ENTRUST SELF-EXPANDING STENT TO TREAT A MODERATELY CALCIFIED LESION IN THE MID LEFT SFA. THE LESION WAS 110 MM IN LENGTH WITH 80% STENOSIS. THE ARTERY DIAMETER WAS 6 MM WITH NO TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THE BOX WAS FULLY INTACT. A 6 FRENCH NON-MEDTRONIC SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE WAS USED IN THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THE LESION WAS PRE-DILATED WITH A 5X120 ADMIRAL DEVICE. THE PHYSICIAN DID NOT EXPERIENCE RESISTANCE DURING ADVANCEMENT AND EXCESSIVE FORCE WAS NOT USED. IT WAS NOTICED UNDER FLUOROSCOPY THAT THE STENT WAS NOT 120 MM IN LENGTH AND THE STENT WAS REMOVED FROM THE PATIENT WITHOUT BEING DEPLOYED. THE BOX THAT THE DEVICE WAS HOUSED IN HAD INDICATED A 120MM STENT HOWEVER THE STENT WAS 60 MM IN SIZE. ANOTHER 7X120 MM EVERFLEX ENTRUST DEVICE WAS OPENED AND DEPLOYED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6871450 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P110023. One submission often covers many models, so check the product and lot details in each record.

• Z-0623-2024 · Nov 20, 2023 · Completed
  Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
• Z-1644-2022 · Jul 14, 2022 · Open, Classified
  EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
• Z-2048-2016 · May 23, 2016 · Terminated
  EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a