EverFlex™ EVD35-06-040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821684051344), received between Jul 8, 2019 and Jan 3, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A EVERFLEX ENTRUST WAS USED TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS MODERATE. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT PHYSICIAN IMPLANTED EXPIRED STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433719 ↗
• MalfunctionOct 18, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AND EVERFLEX ENTRUST FOR TREATMENT OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE STENT WAS PARTIALLY DEPLOYED WHILE IN THE PATIENT ON THE WAY TO TARGET LESION. SAFETY PIN WAS STILL IN PLACE AND THUMBWHEEL WAS NOT TOUCHED THE DEVICE AND STENT WERE SUCCESSFULLY REMOVED FROM THE PATIENT INTACT AND WITHOUT ANY ISSUE. A SECOND DEVICE WAS OPENED AND PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY INJURY OR INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955577 ↗
• MalfunctionSep 4, 2023Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A 6FR NON-MEDTRONIC SHEATH AND A SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING TREATMENT OF 60-80MM CALCIFIED PLAQUE LESION IN THE PATIENTS LEFT MID PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) <(>&<)> POPLITEAL ARTERY. SEVERE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 5-6MM. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY, VERY TORTUOUS ILIACS ARE REPORTED. 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 5X60 NON-MEDTRONIC DEVICE AND A 5MM DCB. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED AN 80MM CTO OF THE DISTAL SFA/PROXIMAL POPLITEAL WAS SUCCESSFULLY CROSSED WITH A VIANCE CATHETER. A SPIDER FX WAS DEPLOYED OVER WHICH LITHOTRIPSY WITH A 5X60 NON-MEDTRONIC BALLOON WAS PERFORMED. TWO DRUG COATED BALLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675992 ↗
• MalfunctionMay 26, 2023Use of Device Problem; Use of Device Problem

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX ENTRUST FOR TREATMENT OF A SOFT TISSUE LESION IN THE MID LEFT POPLITEAL ARTERY. THE VESSEL WAS PRE-DILATED WITH A 2.5MM DEVICE. THE DEVICE WAS PREPPED AS PER THE IFU. IT WAS REPORTED THAT THE STENT IMPLANTED WAS EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009214 ↗
• InjuryOct 17, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX ENTRUST STENT. IT WAS REPORTED THE PATIENT WAS UNDERGOING A LOWER EXTREMITY ARTERI OGRAM. DURING THE PROCEDURE, THE STENT PARTIALLY SEPARATED FROM THE DEPLOYMENT DEVICE WHILE THE SAFETY LOCK REMAINED ENGAGED. STENT AND SHEATH REMOVED, RESULTING IN STENT FRACTURE AND NEED TO CONVERT TO AN OPEN PROCEDURE FOR PRIMARY ARTERIAL REPAIR. POTENTIAL INCOMPATIBILITY OF STENT AND THE NON-MDT CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 15614127 ↗
• MalfunctionSep 29, 2022Fracture; Material Separation

  THE PATIENT WAS UNDERGOING A LOWER EXTREMITY ARTERIOGRAM. DURING THE PROCEDURE, THE STENT PARTIALLY SEPARATED FROM THE DEPLOYMENT DEVICE WHILE THE SAFETY LOCK REMAINED ENGAGED. STENT AND SHEATH REMOVED, RESULTING IN STENT FRACTURE AND NEED TO CONVERT TO AN OPEN PROCEDURE FOR PRIMARY ARTERIAL REPAIR. POTENTIAL INCOMPATIBILITY OF STENT AND COOK TRIFORCE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 15502844 ↗
• MalfunctionSep 15, 2022Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH THE ENTRUST DELIVERY SYSTEM FOR TREATMENT OF A CLACIFIED LESION WITH 90% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY. THE ARTERY HAD MODERATE TORTUOSITY AND CALCIFICATION.  A 6FR X 55CM NON-MDT  SHEATH WAS USED.  THE LESION WAS PRE-DILATED WITH A 5X80 EVERCOSS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED.  THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED AT THE AN UNINTENDED LESION SITE. THE PHYSICIAN USED A SECOND STENT TO COVER THE INTENDED LOCATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15425915 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EVERFLEX ENTRUST STENT IMPLANTED ON (B)(6) 2016. PATIENT ALSO HAD A COMPETITOR¿S STENT IMPLANTED ON (B)(6) 2017. SINCE THEN, THE PATIENT HAS HAD AN ARRAY OF SYMPTOMS SUCH AS CELLULITIS, BONE INFECTIONS, INTERMITTENT CHEST PAIN, 2 TOES AMPUTATED AND A STAPH INFECTION OF HER TOES.

  Patient problems: Bacterial Infection; Cellulitis; Chest Pain; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 8766978 ↗

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