Protégé EverFlex™ PRB35-05-100-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684068601), received between Feb 7, 2022 and Apr 26, 2022 — classified as 2 injuries.

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 16, 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.

• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT REPRESENTATIVE THAT A PATIENT HAS HAD A RASH EVER SINCE HAVING 2 VISI-PRO BALLOON EXPANDABLE STENTS AND 2 PROTÉGÉ EVERFLEX STENTS IMPLANTED TO TREAT THE LEFT ILIAC AND LEFT SFA AND POPITEAL VESSELS. SYMPTOMS STARTED 1 DAY POST PROCEDURE. THE PHYSICIAN DOESN¿T THINK THERE WAS ANY ISSUES DURING STENT IMPLANTATION. PHYSICIAN DID NOT DETERMINE THE STENTS LED TO PATIENT SYMPTOMS. PATIENT CURRENTLY BEING TREATED WITH CREAM PROVIDED BY DERMATOLOGIST. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Rash

  MAUDE report 14209756 ↗
• InjuryFeb 7, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND GUIDEWIRE DURING PROCEDURE TO TREAT A NONE CALCIFIED LESION IN THE PROXIMAL POSTERIOR TIBIAL ARTERY (PTA) AND PERONEAL ARTERY (PA). THE VESSEL WAS NONE TORTUOUS THE VESSEL DIAMETER AND LESION LENGTH ARE 2MM - 3MM AND 2MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. POST STENTING, THE TIP AND DISTAL CATHETER MARKER CAME APART. THE BREAK/FRACTURE OCCURRED AT THE CATHETER. PHYSICIAN TREATED THE POPLITEAL ARTERY (POP), RETRIEVED PIECE FROM THE PERONEAL BIFURCATION OF THE PATIENT. THE DETACHED PORTION OF DEVICE REMAINS IN PATIENT. THE MARKER BEING RADIOPAQUE WAS RETRIEVED, THE PLASTIC NOSECONE (TIP) OF THE STENT CATHETER WAS NOT OBSERVED. THE PATIENT WOULD BE BROUGHT FOR ITS REMOVAL. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT PROCEDURE WAS DONE IN SAFE MANNER, POPLITEAL ARTERY TR

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 13471263 ↗