EverFlex PRB35-08-020-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684069455), received between Nov 22, 2017 and Nov 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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

• MalfunctionNov 22, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX SELF-EXPANDING STENT TO TREAT A RIGHT MID ARTERY MODERATELY CALCIFIED LESION IN THE COMMON ILIAC WITH LITTLE TORTUOSITY. THE ARTERY DIAMETER WAS 7 MM. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU. A 6 FR SHEATH WAS USED WITH A 0.035" GUIDEWIRE AND NO EMBOLIC PROTECTION WAS UTILIZED. THE VESSEL WAS PRE-DILATED USING A 5MM PRE-DILATION DEVICE. THE THUMBSCREW/LOCK-PIN CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE PHYSICIAN WAS NOT MET WITH RESISTANCE DURING ADVANCEMENT. NO EXCESSIVE FORCE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE DISTAL PORTION OF THE STENT WOULD NOT DEPLOY AND FREE ITSELF FROM THE DELIVERY CATHETER. THE STENT WAS FINALLY FREED FROM THE CATHETER, THE STENT WAS PULLED DISTALLY BELOW THE TARGET LESION. THE SURGEON "TUGGED" ON THE STENT CATHETER TO FREE THE STENT, PULLING THE STENT OUT OF POSITION IN THE VESSEL. THE STENT WAS DEPLOYED OUTSIDE OF THE INTENDED LESION SITE. A NEW PROTEGE 8X40 STENT WAS USED TO COVER THE LESION A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7053926 ↗

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