EverFlex™ Protégé™ EverFlex™ PRB35-07-150-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684060155), received between Sep 14, 2018 and Apr 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE PROTEGE EVERFLEX STENTS WERE USED TO TREAT THE RIGHT COMMON ILIAC, EXTERNAL ILIAC. 1 DAY  POST PROCEDURE PATIENT SUFFERED SEVERE LEFT LOWER EXTREMITY CRITICAL LIMB THREATENING ISCHEMIA WITH TISSUE LOSS. BILATERAL LOWER EXTREMITY SEVERE PERIPHERAL ARTERIAL DISEASE WITH TISSUE LOSS OF THE LEFT LOWER EXTREMITY. SEVERE LEFT LOWER EXTREMITY CRITICAL LIMB-THREATENING ISCHEMIA WITH TISSUE LOSS. THE PATIENT UNDERWENT BILATERAL ILIAC ARTERY STENTING TO FACILITATE ABOVE THE KNEE AMPUTATION. BOTH COMMON ILIAC ARTERIES WERE OCCLUDED, AND THE PATIENT HAD AN OCCLUDED SFA ON THE LEFT SIDE. THE FOOT WAS BEYOND SALVAGE, AND IN ADDITION, INFECTED WITH LEUKOCYTOSIS. THE LEFT LOWER EXTREMITY DIGIT 1 GANGRENE AND DIGIT 2 IMPENDING ISCHEMIA AND AN ABI OF .3 UPON ARRIVAL TO THE HOSPITAL. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19163726 ↗
• MalfunctionOct 24, 2019Fracture; Fracture

  PATIENT HAD AN EVERFLEX ENTRUST AND A PROTEGE EVERFLEX STENT(S) IMPLANTED TO TREAT A 300MM LESION IN THE PATIENT¿S MID SUPERFICIAL F EMORAL ARTERY (SFA) OF DIAMETER 7MM. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. PROCEDURE WAS CARRIED OUT AS PER IFU WITHOUT ISSUE. LESION WAS PRE-DILATED. IT IS REPORTED THAT APPROXIMATELY 11 MONTHS POST PROCEDURE, THE PATIENT PRESENTED FOR ANGIO DUE TO LEG PAIN AND A STENT FRACTURE WAS IDENTIFIED. THE STENTS WAS OBSERVED TO BE FRACTURED IN TWO PLACES. IT IS UNKNOWN WHICH STENT FRACTURED. PATIENTS CONDITION IS STABLE. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WILL BE REQUIRED - NONE REPORTED TO DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9231519 ↗
• MalfunctionSep 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN USED THE PROTÉGÉ EVERFLEX, WITH A SPIDER FX 5MM AND 6F NON-MEDTRONIC SHEATH, TO TREAT A SEVERELY CALCIFIED CTO WITH MODERATE VESSEL TORTUOSITY IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 3MM PTA. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS EXPERIENCED AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT, AFTER SUCCESSFUL DEPLOYMENT OF THE STENT, THE STATIONARY PART OF THE DELIVERY SYSTEM BROKE OFF, DETACHING AT THE PROXIMAL PART OF THE STENT DELIVERY SYSTEM. THE DETACHED COMPONENT WAS CAPTURED IN THE SPIDER FX AND REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876164 ↗

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