EverFlex™ Protégé™ EverFlex™ PRB35-06-150-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00821684059982), received between Nov 19, 2018 and Jan 29, 2026 — classified as 1 death, 14 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (7 reports).

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PERIPHERAL ARTERY LESION IN THE SUPERFICIAL FEMORAL ARTERY USING THE STENT PRB35- 06-150-120 PROTEGE EF V10, SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. THE STENT PREMATURELY STARTED TO FLOWER DURING ADVANCEMENT, WHICH PREVENTED DELIVERY TO THE TARGET LESION. THE VESSEL WAS PRE-DILATED PRIOR TO ATTEMPTED STENT PLACEMENT. NO EXCESSIVE FORCE WAS USED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION AND THE PROCEDURE. THE STENT WAS REMOVED AND REPLACED WITH A DIFFERENT STENT, AND THE PROCEDURE WAS COMPLETED USING THE NEW DEVICE. NO INJURY OR HEALTH CONSEQUENCES TO THE PATIENT WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208113 ↗
• MalfunctionDec 16, 2025Premature Activation; Activation, Positioning or Separation Problem; Premature Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A PERIPHERAL ARTERY LESION IN THE SUPERFICIAL FEMORAL ARTERY USING THE STENT PROTEGE EF V10, THE PHYSICIAN EXPERIENCED A DEPLOYMENT ISSUE AS THE DELIVERY SYSTEM WAS STUCK AND UNABLE TO DEPLOY THE STENT. THE SHEATH USED WAS A TERUMO 6FRX45 AND THE GUIDEWIRE WAS A TERUMO 260 GLIDEWIRE ADVANTAGE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE STENT WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION, AND THERE WAS NO VESSEL DAMAGE. THE STENT STRUTS APPEARED TO BE EXPOSED. THE PROCEDURE WAS COMPLETED USING A NEW EVERFLEX 6X200 STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815340 ↗
• MalfunctionDec 11, 2025Activation Failure

  PROVIDERS COULD NOT GET THE STENT TO DEPLOY IN THE SUPERFICIAL FEMORAL ARTERY. WHEN THEY REMOVED THE DEVICE, THE PROVIDER LOOKED AT IT AND ATTEMPTED TO DEPLOY THE STENT, AGAIN, WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778207 ↗
• MalfunctionJul 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE PROTEGE EF V10 IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (PROXIMAL TO MID SEGMENT) FOR A CALCIFIED LESION WITH SEVERE CALCIFICATION, MINIMAL TORTUOSITY, 70-90% STENOSIS, 150MM LESION LENGTH, AND ARTERY DIAMETER OF 5.5-6.0MM, THE PULL HANDLE OF THE STENT DELIVERY SYSTEM BROKE OFF. THE STENT WAS ADVANCED OVER THE 035 WIRE TO TREATMENT AREA, THE KNOB WAS TWISTED TO RELEASE SAFETY MECHANISM. THE PIN PLASTIC HANDLE WAS SECURED WITH RIGHT HAND AND THEN PHYSICIAN STARTED PULLING ¿PULL¿ HANDLE TOWARDS THE RIGHT TO UNSHEATH THE STENT. A FEW CENTIMETERS IN, THE ¿PULL¿ PLASTIC HANDLE BROKE OFF. THE STENT WAS SUCCESSFULLY DEPLOYED THE BY PULLING THE STENT SHEATH NEAR THE CATHETER. THE WHOLE STENT SYSTEM WAS RETRIEVED FROM PATIENT SAFELY WITHOUT ANY INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385136 ↗
• InjuryMay 30, 2025Material Deformation; Material Deformation

  MEDTRONIC PATIENT SERVICES RECEIVED A CALL ABOUT AN ISSUE WITH TWO PROTÉGÉ EVERFLEX STENTS. RESTENOSIS AND COLLAPSED STENTS WERE REPORTED. PHYSICIAN DID BALLOON ANGIOPLASTY AND CLEARED UP ISSUE. NO ADDITIONAL PROBLEMS REPORTED.

  Patient problems: Stenosis

  MAUDE report 22115147 ↗
• 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 21992034 ↗
• MalfunctionApr 18, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE STENT PRB35-06-150-120 PROTEGE EF V10 IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, MID-LOCATION, THERE WERE DIFFICULTIES NOTED. THE DISTAL END (CLEAR SEGMENT) WAS NOT ATTACHED. THE STENT DID NOT DEPLOY CORRECTLY AND WAS DRAGGED AND ELONGATED BEFORE FINALLY RELEASING. THE LESION LENGTH WAS 130 MILLIMETERS. A 6FR NON-MEDTRONIC SHEATH WAS USED. THE VESSEL WAS PRE-DILATED. THE DELIVERY SYSTEM WAS SAFELY REMOVED FROM THE PATIENT. THE STENT REMAINS IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866466 ↗
• MalfunctionApr 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TRANSITION SECTION OF THE PROTEGE EF STENT WAS BROKEN. THE EVENT WAS ASSOCIATED WITH THE PERIPHERAL ARTERY, SPECIFICALLY THE SUPERFICIAL FEMORAL ARTERY, WITH A LESION LENGTH OF 150MM AND AN ARTERY DIAMETER OF 6MM. THE DEVICE WAS NEVER IMPLANTED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, SPECIFICALLY THE EVERFLEX 6X150. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866101 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN PROTEGE EF STENT WAS USED TO TREAT LEFT SUPERFICIAL FEMORAL PROXIMAL. APPROXIMATELY 14 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT LEG ATHEROSCLEROSIS. PATIENT PRESENTED WITH NON-HEALING WOUND. INCREASED SWELLING LEFT FOOT. LEFT LEG ANGIOGRAM WAS RECOMMENDED. ANGIOGRAM PERFORMED. LEFT FEMOROPOPLITEAL ATHERECTOMY ANGIOPLASTY, LEFT ANTERIOR TIBIAL ARTERY ATHERECTOMY ANGIOPLASTY WAS PERFORMED. FOLLOW UP IMAGING DEMONSTRATED WIDELY PATENT FEMOROPOPLITEAL STENT AND WIDELY PATENT ANTERIOR TIBIAL ARTERY PROXIMALLY WITH SOME MILD DISEASE DISTALLY. PATIENT RECOVERED.

  Patient problems: Swelling/ Edema; Ulcer

  MAUDE report 21662251 ↗
• DeathMar 12, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A SELF-EXPANDING STENT WOULD NOT EXPAND OR DEPLOY ONCE UNSHEATHED FROM THE CATHETER. THE PROCEDURE WAS CONDUCTED ON THE LEFT SUPERFICIAL FEMORAL ARTERY, PROXIMAL, WHICH HAD A SEVERE CALCIFIED LESION WITH 100% STENOSIS AND A LENGTH OF 150 MILLIMETRES. THE ARTERY DIAMETER WAS 6 MILLIMETRES. IN RELATION TO THE PATIENT¿S ANATOMY AND PRIOR TO THE PROCEDURE, THE ARTERY WAS CLOTTED OFF WITH A CHRONIC TOTAL OCCLUSION, AND A PNEUMBRA AND LYTIC CATHETER WERE USED OVERNIGHT THE DAY BEFORE. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. 10 MINUTES DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. THE PATIENT DIED ON THE NEXT DAY AND IT IS REPORTED THAT THE CAUSE OF DEATH WAS CARDIAC ARREST.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581656 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTEGE EF STENT WAS USED TO TREAT THE SUPERFICIAL FEMORAL PROXIMAL. APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT LOWER EXTREMITY STENOSIS. PATIENT PRESENTED FOR A FOLLOW UP VISIT, LEFT FOOT PAIN. PATIENT UNDERWENT AN ANGIOGRAM, WHICH SHOWED LEFT POPLITEAL ARTERY STENTS WITH HIGH GRADE STENOSIS AND LEFT PROXIMAL ANTERIOR TIBIAL ARTERY HIGH GRADE STENOSIS. PATIENT UNDERWENT LEFT FEMOROPOPLITEAL ATHERECTOMY AND ANGIOPLASTY, LEFT ANTERIOR TIBIAL ARTERY ATHERECTOMY AND ANGIOPLASTY. FOLLOW UP IMAGING DEMONSTRATED MUCH IMPROVED FLOW. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21410839 ↗
• InjuryApr 11, 2024Material Deformation; Material Deformation

  ON (B)(6) 2024, A PHYSICIAN IMPLANTED A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT DURING TREATMENT OF A 150MM LESION IN THE PATIENT¿S RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY WAS REPORTED. ARTERY DIAMETER REPORTED AS 5MM. 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 WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. ON (B)(6) 2024 STENT DEFORMATION WAS REPORTED. IT WAS REPORTED THAT A MINIMAL STENT FRACTURE WAS NOTED ON POST PROCEDURE SURVEILLANCE AND REINTERVENTION WAS REQUIRED. PHYSICIAN RELINED WITH A COVERED NON-MEDTRONIC (VIABAHN) STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086080 ↗
• InjuryMar 5, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO IMPLANT A PROTEGE EVERFLEX STENT IN THE PATIENTS SUPERFICIAL FEMORAL ARTERY (SFA). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). IT WAS REPORTED THE STENT PARTIALLY DEPLOYED AND HAD TO BE SNARED OUT OF BODY. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836606 ↗
• InjuryDec 14, 2023Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ EVERFLEX STENT WITH A 6FR NON-MEDTRONIC SHEATH AND A 6MM SPIDER FX EMBOLIC PROTECTION DEVI CE/GUIDEWIRE FOR THE TREATMENT OF A 120MM CALCIFIED LESION IN THE PATIENTS LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY D IAMETER REPORTED AS 5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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 DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A HAWKONE M ATHERECTOMY DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THE STENT FRACTURED DURING DEPLOYMENT. THE COMPONENT DID NOT EMBOLIZE. THE DETACHED PORTION OF THE STENT REMAINED IN DELIVER SYSTEM. WHEN DEPLOYING THE STENT THE HUB DETACHED FROM THE DEPLOYMENT SHEATH, THE STENT WAS THEN DEPLOYED TO ITS TARGET LOCATION BY MANUALLY PULLING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18324438 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO PROTEGE EVERFLEX STENTS WERE IMPLANTED IN THE RIGHT PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) (R1). APPROXIMATELY 7 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM A RIGHT THIGH INCISION INFECTION. THE PATIENT WAS SEEN IN THE CLINIC FOR FOLLOW UP FOR A PREVIOUS BYPASS SURGERY. A THIGH INCISION INFECTION WAS NOTED AND THE PATIENT WAS SENT TO HOSPITAL AND UNDERWENT A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS TAKEN TO THE OPERATING ROOM FOR WOUND DEBRIDEMENT AND A WOUND VAC WAS PLACED. THE PATIENT RECOVERED.

  Patient problems: Unspecified Infection

  MAUDE report 17787014 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO PROTEGE EVERFLEX STENTS WERE IMPLANTED IN THE RIGHT PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) (R1). APPROXIMATELY 6 MONTHS LATER, A BYPASS WAS PERFORMED IN THE R1 LESION. APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE AND ONE DAY POST THE BYPASS PROCEDURE THE PATIENT SUFFERED FROM POST OP RIGHT THIGH BLEEDING FROM BYPASS. THE PATIENT WOKE WITH NAUSEA, VOMITING, SWEATING AND PAIN IN THE RIGHT LEG. AN EXAM WAS PERFORMED WHICH SHOWED ECCHYMOSIS. THE PATIENT WAS UNABLE TO MOVE THE RIGHT KNEE, ANKLE AND TOES. THE TOES WERE WHITE WITH DELAYED CAPILLARY REFILL. THE DORSALIS PEDIS AND POSTERIOR TIBIAL PULSES IN THE RIGHT LEG WERE 2+. A CT WAS PERFORMED WHICH SHOWED BLEEDING FROM THE BYPASS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR BLEEDING CONTROL AND REPLACEMENT OF THE BYPASS. THE GRAFT WAS REPLACED AND THE BLEEDING WAS RESOLVED. IT WAS STATED THAT THE EVENT WAS CONSIDERED A TARGET LESION REVASCULARIZATION. THE EVENT WAS ALSO TREATED WITH MEDICATION AND HOSPITALIZATION. THE PATIENT RECOVERED.

  Patient problems: Diaphoresis; Ecchymosis; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Nausea; Pain; Vomiting

  MAUDE report 17593981 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO PROTÉGÉ EVERFLEX STENTS WERE IMPLANTED IN THE RIGHT PROXIMAL, MIDDLE AND DISTAL SUPERFICIAL FEMORAL ARTERIES (SFA) (R1). APPROXIMATELY 4 MONTHS POST PROCEDURE IT WAS REPORTED THAT THE STENT USED DURING THE INDEX PROCEDURE WAS OCCLUDED AT THE PROXIMAL AND MID SEGMENTS. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED THAT THE RIGHT SFA WAS OCCLUDED AND THAT THE RIGHT SFA STENT WAS ALSO OCCLUDED. THE PATIENT HAS NOT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17123566 ↗
• InjuryDec 19, 2022Difficult to Remove; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT A PROTEGE EF STENT FOR THE TREATMENT OF A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE DEGREE OF TORTUOSITY AND CALCIFICATION WAS SEVERE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE THUMB SCREW/LOCK-PIN CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. IT WAS REPORTED THE STENT DID NOT FULLY DEPLOY AND PARTIALLY BROKE OFF. A PORTION OF THE STENT WAS LEFT IN THE PATIENT. STENT DEFORMATION OCCURRED.  DIFFICULTIES WERE EXPERIENCED DURING REMOVAL. A NON-MDT STENT WAS ATTEMPTED TO BE IMPLANTED TO JAIL THE EVERFLEX STENT BUT WAS UNABLE TO CROSS. THE PHYSICIAN USED A ANOTHER EVERFLEX TO JAIL THE INITIAL STENT.

  Patient problems: Insufficient Information

  MAUDE report 16002535 ↗
• InjuryMar 31, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT WITH A 6FR NON-MEDTRONIC 6FR DESTINATION SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 300MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. SLIGHT VESSEL CALCIFICATION IS REPORTED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A 5MM CHOCOLATE BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THE STENT WAS DEPLOYED IN THE SFA WITHOUT ISSUE. WHEN REMOVING THE CATHETER FROM THE PATIENT POST DEPLOYMENT, IT IS REPORTED A PIECE OF THE DELIVERY SYSTEM DETACHED DURING REMOVAL ATTEMPT AND REMAINED IN THE PATIENT. THE DELIVERY SYSTEM DID NOT CATCH ON THE STENT DURING WITHDRAWAL . A GOOSENECK SNARE WAS USED TO RETRIEVE THE DETACHED PORTION. NO FURTHER INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11594663 ↗
• InjuryMar 4, 2021Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A PROTÉGÉ EVERFLEX DURING A PROCEDURE TO TREAT A FIBROUS AND PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 85% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED DURING REMOVAL OF THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. PRE-DILATION WAS NOT PERFORMED. RESISTANCE WAS NOTED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. THE SAFETY LOCK WAS DISENGAGED AFTER POSITIONING TO TARGET AREA. IT IS REPORTED THE PHYSICIAN EXPERIENCED SOME RESISTANCE WHEN ATTEMPTING TO DEPLOY THE STENT. IT WAS CONFIRMED THE SAFETY LOCK WAS DISENGAGED BUT WHEN THE PHYSICIAN PULLED THE LOCK-PIN TO DEPLOY THE STENT IT WAS OBSERVED THAT THE DISTAL PORTION OF STENT FRACTURED OFF. THE REMAINING STENT WAS REMOVED. NO ATTEMPTS WERE MADE TO REMOVE THE FRACTURED PORTION. A SECOND STENT OF THE SAME MODEL WAS PLACED TO COVER THE DETACHED PORTION OF STENT AS WELL AS TARG

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11412393 ↗
• InjuryNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE A PROTÉGÉ EVERFLEX WITH A SPIDER EMBOLIC PROTECTION DEVICE TO TREAT A CALCIFIED CTO IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. THERE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. THERE WAS NO DAMAGE TO THE PACKAGING. PRE-DILATION WAS PERFORMED WITH A EVERCROSS DEVICE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND IT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DEPLOYED AS EXPECTED BUT WHEN THE PHYSICIAN WENT BACK IN WITH ANOTHER STENT IT WAS NOTICED THAT THE DISTAL PORTION OF THE FIRST STENT HAD BROKEN OFF AND WAS FLOATING IN THE POPLITEAL. A SNARE WAS USED TO REMOVE THE SEGMENT OF THE BROKEN STENT. NO INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8085087 ↗

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