EverFlexRecalls & reported problems across all models

We found 14 models of EverFlex by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2017 and Jun 24, 2020 — classified as 12 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EverFlex problems

EverFlex models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EverFlex PRB35-06-060-120

  Stents, drains and dilators for the biliary ducts
  3 reports
• EverFlex PRB35-06-100-120

  Stents, drains and dilators for the biliary ducts
  3 reports
• EverFlex PRB35-06-150-120

  Stents, drains and dilators for the biliary ducts
  3 reports
• EverFlex PRB35-07-040-080

  Stents, drains and dilators for the biliary ducts
  2 reports
• EverFlex PRB35-07-080-120

  Stents, drains and dilators for the biliary ducts
  2 reports
• EverFlex PRB35-08-040-120

  Stents, drains and dilators for the biliary ducts
  2 reports
• EverFlex PRB35-08-060-120

  Stents, drains and dilators for the biliary ducts
  2 reports
• EverFlex PRB35-06-040-120

  Stents, drains and dilators for the biliary ducts
  1 report
• EverFlex PRB35-06-080-120

  Stents, drains and dilators for the biliary ducts
  1 report
• EverFlex PRB35-06-120-120

  Stents, drains and dilators for the biliary ducts
  1 report
• EverFlex PRB35-07-060-120

  Stents, drains and dilators for the biliary ducts
  1 report
• EverFlex PRB35-07-150-120

  Stents, drains and dilators for the biliary ducts
  1 report
• EverFlex PRB35-07-200-120

  Stents, drains and dilators for the biliary ducts
  1 report
• EverFlex PRB35-08-020-080

  Stents, drains and dilators for the biliary ducts
  1 report

Recent EverFlex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX DURING PROCEDURE TO TREAT LESION IN MID SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE DEPLOYED. A DIFFERENT STENT WAS USE TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187900 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A EVERCROSS BALLOON WAS USED TO TREAT THE LEFT VENOUS OUTFLOW. AN EVERFLEX STENT WAS ALSO IMPLANTED DURING INDEX PROCEDURE TO TREAT PERSISTENT RESIDUAL STENOSIS. APPROXIMATELY 12 MONTHS POST PROCEDURE, PATIENT SUFFERED RESTENOSIS OF THE PROXIMAL CEPHALIC VEIN OUTFLOW AND THE VENOUS OUTFLOW WAS TREATED WITH A MEDTRONIC STANDARD PTA BALLOON SAME DAY. THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 9217381 ↗
• InjuryOct 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, AN EVERCROSS BALLOON WAS USED TO TREAT THE LEFT VENOUS OUTFLOW. AN EVERFLEX STENT WAS ALSO IMPLANTED DURING INDEX PROCEDURE TO TREAT PERSISTENT RESIDUAL STENOSIS. APPROXIMATELY 12.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED STENOSIS OF THE CEPHALIC ARCH AND WAS TREATED WITH NON-TARGET LESION REVASCULARISATION OF THE CEPHALIC ARCH USING A MEDTRONIC STANDARD PTA THE SAME DAY. THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 9171275 ↗
• InjuryJul 18, 2019Fracture; Positioning Problem; Fracture; Positioning Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A PROTEGE EVERFLEX STENT TO TREAT A SLIGHTLY CALCIFIED, NON TORTUOUS LESION IN THE LEFT PROXIMAL COMMON ILIAC ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. A 6FR NON-MEDTRONIC SHEATH WAS USED FOR THE PROCEDURE WITH NO EMBOLIC PROTECTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED OR FORCE APPLIED DURING DELIVERY OF THE DEVICE TO THE LESION. THE THUMBSCREW WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN COMPLETELY UNLOCKED THE STENT DEPLOYED IT VIA PIN AND PULL SYSTEM HOWEVER, APPROX. 1-2CM REMAINED UNDEPLOYED AND STUCK IN THE DEPLOYMENT SYSTEM. THE SHEATH WAS USED TO PUSH ON THE STENT TO TRY TO RELEASE THE REMAINING 1-2CM. THE STENT BECAME PUSHED INTO THE AORTA AND RESULTED IN MULTIPLE STENT FRACTURES. THE PATIENT IS SCHEDULED FOR ANOTHER PROCEDURE TO STENT AND REBUILD THE BIFURCATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8801824 ↗
• MalfunctionMay 16, 2019Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, CHRONIC TOTAL OCCLUSION(CTO) 100% STENOTIC FIBROUS LESION IN THE MID/DISTAL/PROXIMAL SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAM ETER AND LESION LENGTH WERE REPORTED TO BE 6MM/300MM, RESPECTIVELY. THE LESION WAS PRE-DILATED WITH A 6X300X130ADMIRAL XTREME BALLOON. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE BALLOON FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 7FR NON-MEDTRONIC SHEATH ALONG WITH A 0.035 NON MEDTRONIC WITH NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE APPLIED WHEN ACCESSING THE LESION. ON FIRST INFLATION TO 6ATM, THE BALLOON BURST. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED FROM THE PATIENT. A NEW 6X300 ADMIRAL XTREME BALLOON WAS USED TO COMPLETE THE PRE-DILATION. THE EVERFLEX STENT WAS THEN INTRODUCED BUT IT WAS REPORTED THAT THE STENT GOT STUCK ON THE 0.035 WIRE. THE STENT AND WIRE HAD TO BE REMOVED AS A UNIT. THE STENT WAS REPORTED TO HAVE FLARED AT THE DISTAL TIP. A NEW WIRE WAS THEN USED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615707 ↗
• MalfunctionMar 13, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EF SELF-EXPANDING STENT TO TREAT A 400MM FIBROUS LESION WITH MODERATE CALCIFICATION AND 90% STENOSIS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE TORTUOSITY WAS REPORTED. ARTERY DIAMETER WAS 6MM. A NON-MEDTRONIC 6FR 45CM SHEATH AND A NON-MEDTRONIC GLIDEWIRE 0.35 X 260 SHEATH WERE USED IN THIS PROCEDURE. NO EMBOLIC PROTECTION WAS USED, NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY), NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED, THE LESION WAS PRE-DILATED WITH AN IN.PACT ADMIRAL (5X200). THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. THE STENT WAS PLACED WITHOUT ANY PROBLEMS AND POST DILATED WITH A 6X200 A NON MEDTRONIC (BSC CHARGER) BALLOON. IT WAS REPORTED THAT THE STENT WAS IMPLANTED 3 DAYS POST EXPIRY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417252 ↗
• MalfunctionJul 24, 2018Material Separation; Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS USING A PROTÉGÉ EVERFLEX FOR TREATMENT. NO ABNORMALITIES WERE NOTED IN RELATION TO PATIENT ANATOMY. NO ISSUES WERE NOTED DURING PREP. IT IS REPORTED THAT FOLLOWING DEPLOYMENT OF THE STENT WHEN THE PHYSICIAN WAS REMOVING THE DEVICE, THE INNER SHEATH CAME APART FROM THE DEVICE AND WAS ALMOST LEFT IN THE PATIENT. NO ADDITIONAL INTERVENTIONS WERE NEEDED TO REMOVE THE SHEATH. NO PATIENT INJURY WAS REPORTED. CASE WAS COMPLETED WITHOUT DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7713293 ↗
• InjuryJul 13, 2018Misfire; Malposition of Device; Malposition of Device

  PHYSICIAN INTENDED TO USE A PROTÉGÉ EVERFLEX WITH A 6F NON-MDT SHEATH AND A STIFF ANGLED GUIDEWIRE FOR TREATMENT OF A 45MM PLAQUE LESION IN THE PATIENTS PROXIMAL LEFT EXTERNAL ILIAC OF DIAMETER 7MM. LESION EXHIBITED 70% STENOSIS. SLIGHT CALCIFICATION AND MODERATE TORTUOSITY WERE REPORTED. EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED. DEVICE WAS PREPPED WITHOUT ISSUE. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THE STENT DEPLOYED WITHIN A SHORT 10CM SHEATH. WHEN THE PHYSICIAN PULLED BACK THE SHEATH THE STENT DEPLOYED IN THE WRONG AREA (LEFT COMMON FEMORAL ARTERY) AND A QUARTER OF IT WAS NOT WITHIN THE ARTERY. A CUT-DOWN WAS PERFORMED TO REMOVE THE STENT FROM THE LEFT COMMON FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED AT THIS POINT. THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 7684987 ↗
• MalfunctionJun 21, 2018Break; Detachment Of Device Component

  AFTER DEPLOYING THE STENT WHEN REMOVING DEVICE, THE INNER SHEATH CAME APART FROM THE DEVICE AND ALMOST LEFT INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7624622 ↗
• MalfunctionMay 30, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THAT AN EXPIRED MEDTRONIC EVERFLEX STENT WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7552203 ↗
• InjuryMay 24, 2018Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE THE PROTÉGÉ EVERFLEX TO TREAT A SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY(SFA), AS PER IFU. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE PHYSICIAN ENCOUNTERED DIFFICULTY CROSSING THE LESION, AFTER SEVERAL ATTEMPTS AND USING EXCESSIVE FORCE THE EVERFLEX CROSSED THE LESION. DURING DEPLOYMENT THE STENT BROKE, THE DISTAL 25MM OF THE STENT DEPLOYED AND REMAINS IN THE PATIENT. THE REMAINING PART OF THE STENT REMAINED INSIDE THE DELIVERY SYSTEM AND WAS REMOVED THROUGH THE SHEATH. AN ADDITIONAL 6X100 EVERFLEX STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7539968 ↗
• InjuryApr 6, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN USED A PROTÉGÉ EVERFLEX WITH A 6FR NON-MDT SHEATH AND A NON-MEDTRONIC 0.035¿ GUIDEWIRE DURING TREATMENT OF A 150 MM CTO PLAQUE LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE LESION WAS REPORTED TO HAVE EXHIBITED LITTLE TORTUOSITY AND LITTLE CALCIFICATION. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE STENT WAS ADVANCED TO THE INTENDED TARGET LOCATION. THE PHYSICIAN PROCEEDED TO LOOSEN SAFETY PIN ON THE STENT, THEN HE PINNED THE PROXIMAL GRIP AND BEGAN TO RETRACT THE DISTAL GRIP TOWARD THE PROXIMAL GRIP. THE STENT THEN FLOWERED AND MIDWAY THROUGH DEPLOYMENT, THE PHYSICIAN FELT RESISTANCE AND THEN A SUDDEN RELEASE AS THE TWO GRIPS MET. ON FLOURO EXAM, THE STENT WAS DIFFICULT TO SEE AS ONLY A SMALL PORTION HAD DEPLOYED. THE MARKERS ON THE DISTAL END OF STENT WERE ALSO DIFFICULT TO SEE. THERE WERE NO FURTHER ACTIONS THAT WOULD ALLOW ANY FURTHER DEPLOYMENT OF THE STENT. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER BUT WHEN IT ARRIVED AT THE SHEATH OPENING IT COULD NOT BE RETRACTED FURTHER. UNDER FLUORO EXAMINATION, IT COULD BE SEEN THAT THE STENT HAD PULLED INTO THE COMMON ILIAC WITH THE CATHETER. RESISTANCE CONTINUED TO BE FELT SO T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7402743 ↗
• MalfunctionMar 29, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX STENT TO TREAT AN UNKNOWN LESION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE PROCEDURE USED A NON-MEDTRONIC 6 FR SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. THERE WAS NO RESISTANCE ADVANCING THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. NO EMBOLIC PROTECTION WAS USED. THE STENT STARTED TO DEPLOY BEFORE IT WAS REMOVED AND A NEW STENT WAS USED WITHOUT INCIDENT. THE PHYSICIAN STATED THEY NOTICED A FEW MMS OF THE DISTAL STENT MARKERS EXITING THE STENT DELIVERY CATHETER UNDER FLOROSCOPY AS IT EXITED THE SHEATH TO BE PLACED AT THE LESION. THE STENT WAS THEN REMOVED UNDEPLOYED VIA THE SHEATH STILL ATTACHED TO THE DELIVERY SYSTEM AND A NEW STENT WAS PLACED WITHOUT INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380737 ↗
• InjuryMar 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN EMPLOYED THE USE OF AN EVERFLEX DEVICE ALONG WITH OTHER UNKNOWN STENTS AND BALLOONS DURING TREATMENT OF A COMPLEX SFA TIBIAL LIMB SALVAGE IN AN ELDERLY PATIENT. IT WAS REPORTED THAT A FOREIGN BODY WAS OBSERVED TO BE WITHIN THE VESSEL POST IMPLANTATION OF THE EVERFLEX STENT. THE PHYSICIAN ATTEMPTED, UNSUCCESSFULLY, TO RETRIEVE THE FOREIGN BODY USING A SPIDER WIRE. AS THE FLOW WAS PATENT AND UNINHIBITED, WITH PULSES, POST-PROCEDURE, NO FURTHER INTERVENTION WAS CARRIED OUT. THE NATURE OF THE FOREIGN BODY WAS UNKNOWN. THE PATIENT IS REPORTED TO HAVE RECOVERED WELL AND TO BE DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7323009 ↗
• InjuryDec 13, 2017Fracture; Fracture

  A PROTEGE EVERFLEX SELF-EXPANDING STENT WAS IMPLANTED IN A CALCIFIED LESION IN THE RIGHT DISTAL SFA IN (B)(6) 2017. THE ARTERY HAD MODERATE TORTUOSITY. DURING A FOLLOW-UP APPOINTMENT, IT WAS DISCOVERED THAT THE STENT HAD FRACTURED. IT WAS REPORTED THAT NO PART OF THE STENT HAD MIGRATED. ANOTHER STENT WAS PLACED INSIDE THE FRACTURED STENT FOLLOWING A PRE-DILATION WITH A 5X100 PRE-DILATION BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7114223 ↗

Other Ev3, Inc products

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• NanoCross Elite63 models · 206 reports
• SpiderFX8 models · 170 reports
• EverFlex Protégé EverFlex27 models · 94 reports
• Protégé GPS26 models · 39 reports · 1 recall
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• NITREX11 models · 30 reports
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