EverFlex PRB35-06-100-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684069226), received between Apr 28, 2017 and May 24, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K060057, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2018Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE THE PROTÉGÉ EVERFLEX TO TREAT A SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY(SFA), AS PER IFU. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE PHYSICIAN ENCOUNTERED DIFFICULTY CROSSING THE LESION, AFTER SEVERAL ATTEMPTS AND USING EXCESSIVE FORCE THE EVERFLEX CROSSED THE LESION. DURING DEPLOYMENT THE STENT BROKE, THE DISTAL 25MM OF THE STENT DEPLOYED AND REMAINS IN THE PATIENT. THE REMAINING PART OF THE STENT REMAINED INSIDE THE DELIVERY SYSTEM AND WAS REMOVED THROUGH THE SHEATH. AN ADDITIONAL 6X100 EVERFLEX STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7539968 ↗
• InjuryDec 13, 2017Fracture; Fracture

  A PROTEGE EVERFLEX SELF-EXPANDING STENT WAS IMPLANTED IN A CALCIFIED LESION IN THE RIGHT DISTAL SFA IN (B)(6) 2017. THE ARTERY HAD MODERATE TORTUOSITY. DURING A FOLLOW-UP APPOINTMENT, IT WAS DISCOVERED THAT THE STENT HAD FRACTURED. IT WAS REPORTED THAT NO PART OF THE STENT HAD MIGRATED. ANOTHER STENT WAS PLACED INSIDE THE FRACTURED STENT FOLLOWING A PRE-DILATION WITH A 5X100 PRE-DILATION BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7114223 ↗
• MalfunctionApr 28, 2017Premature Activation; Premature Activation

  PHYSICIAN WAS ATTEMPTING TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT ILIAC ARTERY USING PROTEGE STENTS. IT WAS REPORTED THAT THE STENTS FAILED TO CROSS THE LESION AND A DIFFERENT SHORTER STENT WAS USED IN TANDEM TO COMPLETE PROCEDURE. THERE WAS NO INJURY TO PATIENT. THE FIRST STENT USED HAD BECOME FRAYED ON THE EDGE SO A SECOND STENT WAS PULLED. THE SECOND STENT WOULD NOT PASS EITHER BUT THE STENT STRUTS DID NOT GET FRAYED LIKE THE FIRST STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6529336 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060057, 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
• Z-1598-2010 · Mar 31, 2010 · Terminated
  ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx on
• Z-0478-2010 · Nov 6, 2009 · Terminated
  Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, M