Protégé EverFlex™ PRB35-05-040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684068540), received between Jul 2, 2020 and Mar 11, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Material Deformation

  LIMITED INFORMATION REPORTED THAT STENT DEFORMATION WAS OBSERVED WITH THE PRB35-05-040-120 PROTEGE EF STENT. THE STENT REMAINS IMPLANTED IN THE PATIENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567555 ↗
• InjuryJul 2, 2020Entrapment of Device; Fracture; Detachment of Device or Device Component; Entrapment of Device; Fracture; Detachment of Device or Device Component

  THE PHYSICIAN ATTEMPTED TO USE A PROTÉGÉ EVERFLEX STENT TO TREAT A SOFT TISSUE PLAQUE WITH LITTLE CALCIFICATION AND UNKNOWN % LESION STENOSIS IN THE LEFT MID TIBIAL/POPLITEAL TRUNK. THE ARTERY DIAMETER WAS 5MM AND LESION LENGTH WAS 40 MM. THE STENT WAS APPLIED TO TRAP CLOT, CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE SFA. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A 6F 45CM NON-MEDTRONIC SHEATH FRENCH AND WHOLEY WIRE WERE USED. NO EMBOLIC PROTECTION WAS 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 NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT A BREAK/FRACTURE OCCURRED AT THE CATHETER TIP. THE STENT CATHETER WAS PULLED OUT OF THE PATIENT AFTER DEPLOYMENT AND THE TIP WAS NOTICED ON FLUOROSCOPY. THE COMPONENT EMB OLIZED IN THE VESSEL. THE DETACHED PORTION OF DEVICE DID NOT REMAIN IN THE PATIENT AND WAS REMOVED WITH A SNARE, THE PATIENT WAS NOT HARMED. THERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223549 ↗