Protégé EverFlex™ PRB35-05-080-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684068588), received between Jul 9, 2018 and Sep 23, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO IMPLANT A PROTEGE EVERFLEX STENT WITH A 035 GUIDEWIRE FOR THE TREATMENT OF A SOFT TISSUE LESION IN THE PATIENTS LEFT MID ARTERIOVENOUS FISTULA. SEVERE TORTUOSITY WAS REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE MARKERBAND DISLODGED DURING USE IN THE PATIENT. THE STENT WAS DEPLOYED IN THE TARGET LOCATION AND REMAINS IN THE PATIENT. THERE WAS NO DEFORMATION NOTED TO THE DEPLOYED STENT. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF FOREIGN BODY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278597 ↗
• InjurySep 22, 2021Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN PROTÉGÉ EVERFLEX SELF-EXPANDING STENT TO TREAT A FIBROUS LESION IN A FISTULA. A 6FR NON-MEDTRONIC SHEATH WAS USED. A .035 GUIDEWIRE WAS USED. DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. STENT WAS IN THE SHEATH. THEY PULLED THE SHEATH OUT OF THE BODY. DISLODGED STENT WAS REMOVED FROM PATIENT. A SECOND PROTÉGÉ EVERFLEX STENT WAS OPENED. A 6FR NON-MEDTRONIC SHEATH WAS USED. A .035 GUIDEWIRE WAS USED. IFU WAS FOLLOWED. STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. STENT WAS SURGICALLY REMOVED. PATIENT WAS IN THE OR AND SURGEON DID A REVISION ON THE FISTULA. NO FURTHER INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12512658 ↗
• InjuryNov 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PROTÉGÉ EVERFLEX SELF EXPANDING STENT TO TREAT A CTO IN THE RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE LESION WAS CROSSED WITH A WIRE AND ATHERECTOMY PERFORMED FOLLOWED BY BALLOON INFLATION. THE PHYSICIAN THEN INSERTED THE SELF EXPANDING STENT. THE STENT WAS ADVANCED AND DEPLOYED SUCCESSFULLY. IT WAS REPORTED THE DELIVERY CATHETER WAS WITHDRAWN, A DEVICE COMPONENT WAS OBSERVED BY ANGIOGRAM AT THE LATERAL BRANCH OF THE PROFUNDA ARTERY PROXIMAL TO THE DEPLOYED STENT. ATTEMPTS TO SNARE THE COMPONENT WAS UNSUCCESSFUL. ANGIOGRAM SHOWS FOREIGN BODY IN THE LATERIAL BRANCH OF THE PROFUNDA ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8054563 ↗
• MalfunctionJul 9, 2018Difficult to Remove; Detachment of Device or Device Component

  PATIENT IN CATH LAB FOR RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) LEG INTERVENTION. TOTAL OCCLUSION CROSSED WITH WIRE, ATHERECTOMY PERFORMED AND BALLOON INFLATION COMPLETED. DECISION TO INSERT SELF-DEPLOYMENT STENT. STENT ADVANCED WITHOUT DIFFICULTY AND SELF-DEPLOYMENT COMPLETED. DELIVERY CATHETER WITHDRAWN AND NOTICED TO BE MISSING BY SCRUB TECH. ANGIOGRAM SHOWS FOREIGN BODY AT PROFUNDA ARTERY PROXIMAL TO DEPLOYED STENT. ATTEMPTS TO SNARE FOREIGN BODY UNSUCCESSFUL. ANGIOGRAM SHOWS FOREIGN BODY IN LATERAL BRANCH OFF OF PROFUNDA.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7669343 ↗