Protégé EverFlex™ PRB35-05-060-120Recalls & reported problems
Ev3, Inc · STENT PRB35-05-060-120 PROTEGE EF V08 · Class 3 · Implant
All models of Protégé EverFlex (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684068564), received between Sep 22, 2021 and Sep 22, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
Device problems
- Activation, Positioning or Separation Problem1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2021Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated
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: No Clinical Signs, Symptoms or Conditions
MAUDE report 12512662 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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