EverFlex™ Protégé™ EverFlex™ PRB35-08-080-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684060261), received between Mar 23, 2018 and Mar 23, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST STENT TO TREAT A 20 MM MODERATELY CALCIFIED PLAQUE LESION (80% STENOSIS) IN THE RIGHT PROXIMAL COMMON ILIAC ARTERY. THE ARTERY DIAMETER WAS 7 MM IN DIAMETER AND WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 5 FR SHEATH AND A 0.035¿ GUIDEWIRE. THE LESION WAS PRE-DILATED USING A 6 MM PRE-DILATION DEVICE. IT WAS REPORTED THAT THERE WAS NO DIFFICULTY ENCOUNTERED ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. DURING DEPLOYMENT OF THE STENT IT WAS REPORTED THAT THE PHYSICIAN COULDN¿T SEE THE SHEATH AND THE DEPLOYED STENT ACROSS THE LESION AND IN THE SHEATH. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM (SDS). THE PHYSICIAN COULD NOT SEE THE TIP OF THE ACCESS SHEATH. THE STENT ELONGATED WHEN THE SDS AND SHEATH WERE REMOVED. THE STENT SEPARATED - HALF OF THE STENT REMAINED IN THE SHEATH AND ON SDS. THE REST OF THE STENT WAS ELONGATED AND PULLED THROUGH THE ARTERIOTOMY. IT WAS REPORTED THAT HEMOSTASIS WAS CONTROLLED BY PLACING A NEW SHEATH. AN ENDARECTOMY WAS PERFORMED TO RE

  Patient problems: Atherosclerosis; Patient Problem/Medical Problem

  MAUDE report 7365852 ↗

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