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

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00821684068625), received between Jan 4, 2017 and Jan 27, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PRB35-05-120-120 PROTEGE EF STENT, MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. AS THE STENT WAS BEING ADVANCED IN THE PATIENT, IT PREMATURELY STARTED TO FLOWER, WHICH PREVENTED ADVANCEMENT TO THE TARGET LESION IN THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND REPLACED WITH A DIFFERENT STENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186818 ↗
• InjuryMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO PROTEGE EF STENTS, THERE WERE SEVERAL HOURS OF DELAYS DUE TO PRODUCT MALFUNCTION. THE DEVICES WERE INTENDED TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THERE WAS NO RESISTANCE WHEN ADVANCING EITHER DEVICE. AFTER IMPLANTING THE FIRST PROTEGE EF THE TIP OF THE DELIVERY CATHETER BROKE OFF, NECESSITATING A CUT DOWN PROCEDURE TO REMOVE THE BROKEN CATHETER. THE SECOND PROTEGE EF STENT WAS DEPLOYED PROPERLY, THE END OF THE STENT CATHETER TIP BROKE OFF POST-DEPLOYMENT, REQUIRING REMOVAL FROM THE BLOOD VESSEL VIA SHEATH CAPTURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21992044 ↗
• InjuryApr 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT AND AN INPACT ADMIRAL DCB BALLOON DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENT¿S RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). 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 IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE DISTAL OUTER SHEATHING / TIP OF STENT BROKE OFF IN THE VESSEL DURING PROCEDURE AND HAD TO BE SURGICALLY REMOVED. THE STENT WAS SUCCESSFULLY DEPLOYED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE INPACT ADMIRAL. INFLATION DIFFICULTIES WERE REPORTED. NO LEAKS WERE NOTED ON THE DEVICE. THE INPACT ADMIRAL WAS SAFELY REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077490 ↗
• MalfunctionJun 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PROTEGE EVERFLEX STENT WAS DEPLOYED OVER A 0.35 WIRE WITHOUT DIFFICULTY. THE PHYSICIAN REMOVED THE STENT CATHETER FROM THE BODY AND NOTICED THE END OF THE CATHETER WAS MISSING, PHYSICIAN THEN REMOVED THE WIRE AND FOUND THE TIP AND THE END OF STENT CATHETER ATTACHED TO THE WIRE. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: Insufficient Information

  MAUDE report 14753990 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 100MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DETACHED WHEN BEING REMOVED FROM THE BODY OVER THE WIRE. CATHETER BREAK/FRACTURE OCCURRED. THE DETACHED PORTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT, THE DETACHED PORTION WAS STUCK ON THE WIRE. THE LESION WAS PREDILATED WITH AN INPACT ADMIRAL 4 X 120 DCB. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE WIRE REMOVED WITH THE BROKEN PIECE OF CATHETER ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307047 ↗
• InjuryNov 20, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN IMPLANTED A PROTEGE EVERFLEX STENT IN LITTLE CALCIFIED AND MODERATELY TORTUOUS MID POPLITEAL VESSEL WITH 80% STENOSIS. THE DEVICE WAS USED ALONG WITH 6MM SPIDER FX. THE DEVICE WAS PREPPED PER THE IFU. IT WAS REPORTED THAT DURING REMOVAL OF DELIVERY SYSTEM AFTER STENT DEPLOYMENT, THE TIP DETACHED IN THE SHEATH AND WAS CAPTURED USING A SNARE. STENT WAS DEPLOYED CORRECTLY BUT THE TIP OF CATHETER CAME OFF AFTER DEPLOYMENT. IT WAS PULLED BACK INTO THE SHEATH AND WAS ABLE TO SNARE IT WITH NO ISSUES. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE.

  Patient problems: Injury

  MAUDE report 9346570 ↗
• MalfunctionMar 27, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX STENT TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS, 100%(CHRONIC TOTAL OCCLUSION, CTO) STENOTIC LESION IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE 5MM 300MM, RESPECTIVELY. THE LESION WAS PRE-DILATED WITH A 3MM DEVICE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND A A 0.035X300CM NON-MEDTRONIC GUIDEWIRE WERE USED FOR THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE WAS APPLIED DURING DELIVERY OF THE DEVICE TO THE LESION. THE ACTUAL PROCEDURE WAS CARRIED OUT WITHOUT INCIDENT. AFTER DEPLOYMENT OF THE STENT AND POST THE PROCEDURE, IT WAS NOTED THAT THE DEVICE ITSELF WAS EXPIRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455755 ↗
• InjuryMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A PROTÉGÉ EVERFLEX DURING TREATMENT OF A CALCIFIED/PLAQUE LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY) EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THE DELIVERY SYSTEM BECAME STUCK AND A PIECE OF THE PROXIMAL STENT BROKE OFF DURING ATTEMPTED REMOVAL RESULTING IN THE DETACHED PORTION EMBOLISING AT THE TARGET LESION. ANOTHER EVERLFEX ENTRUST WAS PLACED OVER THE DETACHED PORTION. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8420981 ↗
• InjuryJan 31, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A PROTEGE EVERFLEX STENT TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY(SFA). THE DEVICE WAS REMOVED FROM THE PACKAGING WITH NO DAMAGE NOTED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. UPON REMOVAL, IT WAS REPORTED THAT THE PROXIMAL END OF THE STENT BROKE AND CAME OUT OF THE SHEATH. THE REMAINDER OF THE STENT DEPLOYED AS EXPECTED IN THE INTENDED LOCATION. NO EMBOLIZATION WAS REPORTED. THE PHYSICIAN WAS CONCERNED ABOUT FURTHER FRACTURE OF THE STENT AND THE DAMAGE TO THE STRUTS SO A NON-MEDTRONIC DEVICE WAS DEPLOYED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8292129 ↗
• MalfunctionJan 16, 2018Fracture; Fracture

  THE PHYSICIAN HAD USED A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT TO TREAT A 200 MM LONG CALCIFIED LESION IN THE RIGHT MID SFA WITH A LITTLE DEGREE OF TORTUOSITY AND A SEVERE DEGREE OF CALCIFICATION AND CTO ON (B)(6) 2017 AFTER LASER ATHERECTOMY AND PRE-DILATION WITH A 3.5X100 NANOCROSS BALLOON. THE ARTERY DIAMETER IS 6 MM AND NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. A 6FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE WERE USED FOR THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING AND NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE VESSEL WAS PRE-DILATED USING A 3.5X100 NANOCROSS. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT EXCESSIVE FORCE WAS NOT USED. THE VESSEL WAS NOT POST DILATED AFTER INITIAL STENT DEPLOYMENT. IT WAS REPORTED THE ANGIOGRAM COMPLETED POST STENT PLACEMENT SHOWED LIMITED AND SLOW BLOOD FLOW AND THE PHYSICIAN WAS AWARE OF INITIAL CALCIFIED CHRONIC TOTAL OCCLUSION WITH SUBOPTIMAL RESULTS AND DECIDED ON MEDICAL MANAGEMENT FOR THE PATIENT. AT THE FOLLOW-UP APPOI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7195069 ↗
• MalfunctionJan 4, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ATTEMPT TO TREAT A FIBROUS TOTALLY OCCLUDED LESION USING A PROTEGE STENT, IT WAS REPORTED THAT THE PHYSICIAN STARTED BY TAKING PICTURES OF THE TOTALLY OCCLUDED SFA TO POPLITEAL. IT WAS REPORTED THAT THE PHYSICIAN THEN INSERTED A 6X5 SHEATH AND THEN BALLOONED WITH AN AMPLATZ SUPER STIFF WIRE. THE FIRST STENT - A 5X120 ¿ WAS INSERTED RIGHT AT THE HUNTERS CANAL. THEN ANOTHER STENT - A 5X120 ¿ WAS DELIVERED. HOWEVER, WHEN THE PHYSICIAN CHECKED THE SCREEN HE DECIDED THAT SOMETHING DID NOT LOOK RIGHT. SO, HE PULLED THE STENT OUT AND THE NOSE CONE WAS ALL THE WAY INTO THE OUTER SHEATH. ON THE BACK TABLE, THE STENT WAS PARTIALLY DEPLOYED TO MAKE SURE IT WAS STILL IN THE DEVICE. THE PHYSICIAN THEN TOOK THE DEPLOYED STENT AND AS THE PHYSICIAN BROUGHT IT OUT OF THE SHEATH, THE NOSE CONE BROKE OFF. THE PHYSICIAN THEN CHANGED THE SHEATH OUT AND USED A 7X45 SHEATH. THE PROCEDURE WAS COMPLETED USING A 6X150 UNKNOWN STENT. THE PHYSICIAN THEN POST DILATED WITH AN UNKNOWN DEVICE. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6222473 ↗