Protege RX SECX-10-60-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821684038680), received between Jun 21, 2017 and Jun 30, 2022 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (P060001); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE RX SELF-EXPANDING STENT ALONG WITH A SPIDER FX GUIDEWIRE DURING PROCEDURE. THERE WAS NO DAMAGE TO THE PACKAGE. THERE WAS NO DEFECT WHEN REMOVING THE PRODUCT FROM THE PACKAGE OR TRAY. IT WAS REPORTED THAT WHEN PROTÉGÉ WAS DEPLOYED AT THE LESION SITE, THE GRIP WAS FIXED AND THE Y-BODY WAS INSERTED INTO THE GRIP SIDE, BUT IT COULD NOT BE DEPLOYED WITHOUT BEING TRAPPED. THERE WAS NO RESISTANCE DURING DELIVERY TO THE LESION. THE PRODUCT DID NOT PASS THROUGH AN ALREADY IMPLANTED STENT. PARTIAL EXPANSION OF THE STENT WAS REPORTED. THE SCREW OR LOCK-PIN WAS CHECKED PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14870758 ↗
• MalfunctionNov 12, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE A PROTÉGÉ RX DURING TREATMENT OF A LESION IN THE PATIENT¿S MID COMMON CAROTID ARTERY. MODERATE VESSEL TORTUOSITY IS REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS REPORTED DURING ADVANCEMENT. THE DEVICE WAS DELIVERED TO THE TARGET LESION, BUT IT IS REPORTED DEPLOYMENT ISSUES WERE ENCOUNTERED. THE PHYSICIAN WAS HESITANT AS TO WHETHER TO CONTINUE ATTEMPTING TO DEPLOY THE DEVICE WAS THERE WAS NO SIGN THE TIP PART WOULD DEPLOY EVEN THOUGH IT WAS PULLED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A DIFFERENT SIZED PROTÉGÉ RX WAS USED AS NONE OF THE SAME SIZE WERE AVAILABLE TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829301 ↗
• MalfunctionMar 9, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE A PROTEGE RX WITH A 9FR25 CM NON-MEDTRONIC SHEATH AND A 7FR200CM GUARDWIRE FOR TREATMENT. EMBOLIC PROTECTION WAS USED. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO DIFFICULTIES WERE EXPERIENCED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A NON-MEDTRONIC DEVICE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PRE-DEPLOYED STENT. IT WAS REPORTED THAT UPON DEPLOYMENT ATTEMPT AT THE LESION, THE INNER SHEATH GOT STUCK TO THE OUTER SHEATH AND THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9806072 ↗
• MalfunctionFeb 7, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO TREAT THE MID CAROTID ARTERY USING PROTEGE STENT. THE SHEATH WAS SO HARD THAT THE PROTEGE WHICH WAS DELIVERED BUT COULD NOT BE DEPLOYED. A NEW PRODUCT WITH THE SAME SIZE WAS USED WITHOUT ISSUES AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9680510 ↗
• MalfunctionJan 30, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN ATTEMPTED TO USE A PROTEGE RX CAROTID STENT DURING TREATMENT OF A LESION IN THE PATIENT¿S MID COMMON CAROTID ARTERY. THERE WAS NO CALCIFICATION. VESSEL TORTUOSITY IS REPORTED. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. PRE-DILATION WAS PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. IT IS REPORTED THAT THE STENT WAS UNABLE TO BE DEPLOYED. THE DEVICE SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED WITH A NON-MEDTRONIC CAROTID DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648190 ↗
• DeathOct 17, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN USED A PROTÉGÉ RX WITH A NON-MEDTRONIC GUIDEWIRE AND NON-MEDTRONIC 9F GUIDE CATHETER TO TREAT A TORTUOUS 40MM CALCIFIED LESION WITH 90% STENOSIS IN THE CAROTID ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO DIFFICULTIES NOTICED. IT WAS REPORTED THE LESION WAS PRE-DILATED WITH A NON-MEDTRONIC DEVICE. A 10X60MM PROTÉGÉ RX WAS ADVANCED AND DEPLOYED WITHOUT ENCOUNTERING ANY RESISTANCE. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITH NO DIFFICULTY NOTICED. IT WAS CONFIRMED BY (B)(4) THAT THE STENT WAS ELLIPTICAL IN SHAPE. SEVERAL ADDITIONAL POST DILATIONS WERE CARRIED OUT TO IMPROVE BLOOD FLOW. THE PROCEDURE WAS FINISHED AT THIS POINT. THE BALLOON WAS ALSO OBSERVED TO BE IN AN ELLIPTICAL STATE ONCE REMOVED FROM THE PATIENT FOLLOWING POST-DILATION. THE PHYSICIAN REPORTS THAT THERE WAS NO CALCIFICATION AS THE BALLOON INFLATED WITHOUT ISSUE. ONE (1) WEEK POST PROCEDURE, THE PATIENT WAS TREATED FOR IC OCCLUSION. TWO (2) NON-MEDTRONIC DEVICES WERE PLACED INSIDE THE PROTEGE STENT. AN MRI WAS CARRIED OUT INDICATED THE PATIENT¿S OUTCOME WAS NOT GOOD AND CONDITION WAS DETERIORATING. THE PATIENT WAS DUE TO PRESENT FOR A FOLLOW-UP PROCEDURE, HO

  Patient problems: Death

  MAUDE report 7973383 ↗
• InjurySep 3, 2018Material Deformation; Material Deformation

  PHYSICIAN USED A PROTÉGÉ STENT WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING A CAROTID ARTERY STENTING PROCEDURE. IT REPORTED AT THE END OF THE PROCEDURE POST STENT DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE DUAL END CATHETER IN ORDER TO REMOVE SPIDER FX BUT THE CATHETER COULD NOT BE ADVANCED RESULTING IN THE SPIDER FX BEING UNABLE TO BE REMOVED. THE PHYSICIAN THEN REALISED THAT THE PROTÉGÉ STENT WAS OBSERVED TO BE CURVED INWARDS RESULTING IN LESS SPACE FOR THE CATHETER TO BE PASSED THROUGH. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AND THE SPIDER FX SUCCESSFULLY REMOVED FROM THE VESSEL DISTAL FROM THE STENT PLACED. THE PATIENT HAS RECOVERED, AND THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7840850 ↗
• InjuryJun 21, 2017Material Deformation; Material Deformation

  PHYSICIAN WAS USING A PROTÉGÉ RX CAROTID STENT SYSTEM WITH A NON-MEDTRONIC GUIDEWIRE, NON-MEDTRONIC 8F GUIDE CATHETER AND NON-MEDTRONIC 8F SHEATH FOR TREATMENT OF A 50MM LESION WHICH HAD A MEDIUM LEVEL OF CALCIFICATION IN THE INTERNAL CAROTID ARTERY AND COMMON CAROTID ARTERY. THE LESION EXHIBITED 90% STENOSIS. THE DEVICE WAS PREPPED AS PER THE IFU WITHOUT ISSUE. THERE WAS NO UNUSUAL RESISTANCE NOTED WHEN THE PROTECTIVE SHEATH WAS REMOVED. THE LESION WAS NOT PRE-DILATED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN PASSING THE LESION. UPON REMOVAL OF THE EZ FILTER AFTER POST-DILATION THE CATHETER OF THE FILTER GOT CAUGHT BY THE STRAND OF THE PROTÉGÉ STENT STRUT. THE PHYSICIAN REPEATEDLY PUSHED AND PULLED THE FILTER AND ALSO STRETCHED THE PATIENT¿S NECK AND APPLIED PRESSURE TO REMOVE THE CATHETER. THE FILTER AND CATHETER WERE REMOVED FROM THE PATIENT SUCCESSFULLY. THE PHYSICIAN LATER TOOK A CT IMAGE AND NOTICED THAT THE PROTÉGÉ WAS DEFORMED INWARD. INTERVENTION PROCEDURE WAS CARRIED OUT ON (B)(6) TO FIX THE DEFORMATION USING A BALLOON. PATIENT¿S CURRENT STATUS IS REPORTED AS FINE WITH NO ADVERSE ISSUE REPORTED. THE STENT WAS IMPLANTED DURING THIS PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6659390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060001. One submission often covers many models, so check the product and lot details in each record.

• Z-0879-2015 · Dec 4, 2014 · Terminated
  ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterect
• Z-0878-2015 · Dec 4, 2014 · Terminated
  ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endartere