EverFlex™ Protégé™ EverFlex™ PRB35-06-200-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00821684059999), received between Mar 13, 2020 and Feb 23, 2026 — classified as 15 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF A LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY WITH A 6X200MM PROTEGE EF, PARTIAL DEPLOYMENT OF THE STENT OCCURRED AT THE TARGET SITE WITHIN THE PATIENT VASCULATURE. THE ARERY WAS 6MM IN DIAMETER. DURING DEPLOYMENT, THE STENT STOPPED DEPLOYING AND THE PIN BROKE, AND THE STENT WOULD NOT CONTINUE TO DEPLOY. THE PROCEDURE WAS COMPLETED BY MANIPULATING THE DEVICE TO ACHIEVE FULL DEPLOYMENT. ELONGATION OF THE DEPLOYED STENT WAS NOTED. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED USING AN EVERCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. EMBOLIC PROTECTION WAS USED WITH A 4MM SPIDER DEVICE. THE DELIVERY SYSTEM WAS SAFELY REMOVED, AND THE STENT REMAINED IMPLANTED IN THE PATIENT. NO VESSEL DAMAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413828 ↗
• MalfunctionJan 29, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A CHRONIC TOTAL OCCLUSION OF THE RIGHT MID SUPERFICIAL FEMORAL ARTERY WITH A CALCIFIED, FIBROUS PLAQUE LESION (160 MM LENGTH, 50% STENOSIS, 6 MM DIAMETER), THE PROTEGE EF V10 STENT WOULD NOT DEPLOY. THE STENT STRUTS WERE BARELY EXPOSED AND HAD NOT BEGUN TO FLOWER IN THE BODY, AND THE NOSECONE APPEARED TO BE MISSING FROM THE STENT. THE NOSECONE WAS NOT LOCATED OUTSIDE THE PATIENT. RUNOFF IMAGING WAS OBTAINED WITHOUT FLOW DEFECT, AND ANGIOGRAPHY WAS PERFORMED, THOUGH AN IMAGE IN THE PATIENT'S BODY WAS NOT SAVED. THE VESSEL WAS CROSSED AND PRE-DILATED WITH A NANOCROSS BALLOON, A SPIDER FX WAS PLACED AT THE MID POPLITEAL ARTERY, AND THREE PASSES WERE MADE WITH A TURBOHAWK M DEVICE. THE VESSEL WAS POST-DILATED WITH A PACIFIC PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON, AND THE SPIDER WAS REMOVED. WHEN THE STENT WOULD NOT DEPLOY, VIDEO ASSISTANCE WAS SOUGHT. THE STENT WAS REMOVED FROM THE PATIENT AND DEPLOYMENT WAS ATTEMPTED OUTSIDE THE BODY, BUT THE STENT COULD NOT BE DEPLOYED. MUCH MORE OF THE STENT WAS EXPOSED AFTER REMOVAL THAN WAS VISUALIZED ON ANGIOGRAPHY. THE TECHNICAL STAFF STATED CONFIDENCE THAT THE NOSECONE WAS IN PLACE WHEN THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209289 ↗
• MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE PROXIMAL AND MID SEGMENTS OF THE LEFT SUPERFICIAL FEMORAL ARTERY USING THE PROTEGE EF V10, A PATIENT UNDERWENT VESSEL PRE-DILATION AND POST-DILATION. SEVERE CALCIFICATION OF THE TARGET LESION WAS NOTED, AND MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE TIP OF THE STENT DELIVERY SYSTEM DETACHED IN VIVO AT THE TARGET LESION AND WAS SUBSEQUENTLY REMOVED WITHIN THE SHEATH. THE PROCEDURE WAS ABORTED. THE DISTAL PORTION OF THE STENT DELIVERY SYSTEM DETACHED. NOT JUST THE TIP, THE TIP AND THE INNER FILAMENT. THE STENT DEPLOYED COMPLETELY AND EVERYTHING WAS REMOVED FROM PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415260 ↗
• 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 22115164 ↗
• InjuryFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TREATMENT OF A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY USING A PROTEGE EVERFLEX STENT, A SEVERE DEGREE OF CALCIFICATION WAS NOTED. THE DELIVERY SYSTEM TIP DETACHED IN VIVO AT THE TARGET LESION. THE DETACHED COMPONENT WAS SUCCESSFULLY REMOVED BY SNARING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21411855 ↗
• InjuryJun 18, 2024Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO IMPLANT A PROTEGE EVERFLEX SELF-EXPANDING STENT WITH A 45CM 6FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 180MM FIBROUS LESION IN THE PATIENT¿S RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. VEIN DIAMETER REPORTED AS 5.5MM. 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 IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS POST DILATED WITH A 3.0 X 210 RAPIDCROSS BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. STENT DEFORMATION/ELONGATION MID DEPLOYMENT DURING PROCEDURE WAS REPORTED. DEFORMATION WAS NOT NOTICED IN VIVO DURING POSITIONING. STENT PLACEMENT WAS NOT ADJUSTED AFTER INITIAL FLOWERING OF STENT. THE LENGTH OF THE DEPLOYED STENT IN VESSEL WAS 200M. THE DELIVERY SYSTEM WAS SAFELY REMOVED FROM THE PATIENT. A SECOND 6X150MM PROTÉGÉ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558779 ↗
• InjuryNov 23, 2023Fracture; Fracture

  A PHYSICIAN IMPLANTED A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT IN A PATIENTS LEFT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). NO VESSEL TORTUOSITY REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. PATIENT CAME BACK IN FOR A PROCEDURE APPROXIMATELY 32 MONTHS LATER AND THE PHYSICIAN NOTICED THE PREVIOUSLY DEPLOYED STENT WAS FRACTURED IN THE ADDUCTOR CANAL. PHYSICIAN RE-INTERVENED AND RELINED IT WITH ANOTHER MEDTRONIC BARE METAL STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18202773 ↗
• 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 17787010 ↗
• 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 17593974 ↗
• InjuryAug 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PROTEGE EF WAS IMPLANTED ON AN UNKNOWN DATE FOR THE TREATMENT OF A CALCIFIED LESION WITH 80% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY. THERE WERE PATIENT COMPLICATIONS WITH THIS EVENT, VESSEL OCCLUSION DUE TO  RESTENOSIS, WITH INTERVENTION, RELATED TO TARGET VESSEL. THE DEVICE HAS BEEN PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE DILATED WITH A 5X150MM DEVICE. THE DEVICE DID NO PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS MET DURING ADVANCEMENT. IT WAS REPORTED THE STENT FRACTURED IN MULTIPLE PLACES AFTER APPROXIMATELY 6 MONTHS IMPLANTED. THE STENT FRACTURE WAS ADDRESSED BY THE DOCTOR RE-DILATING AND PLACING NEW STENTS INSIDE OF THE FRACTURED STENTS. THEN POST-DILATED. IT WAS REPORTED THAT ONLY ONE MEDTRONIC STENT FRACTURED. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: Insufficient Information; Obstruction/Occlusion; Stenosis

  MAUDE report 17562647 ↗
• 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 17123559 ↗
• MalfunctionMar 31, 2023Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation

  A PROTEGE EF SELF-EXPANDING STENT WAS BEING IMPLANTED FOR THE TREATMENT OF A 180MM CALCIFIED LESION WITH 80% STENOSIS IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION. THE VESSEL DIAMETER WAS 6MM. A 7FR SHEATH AND A 0.014 NON MEDTRONIC WIRE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 6MM DILATION DEVICE. LOCK-PIN WAS CHECKED FOR SECUREMENT. THE LOCK-PIN WAS NOT REMOVED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED PARTIAL DEPLOYMENT OCCURRED THE PROXIMAL STENT DEPLOYED IN THE SHEATH, WHEN THE SHEATH WAS PULLED BACK THE STENT WAS STUCK ON THE SHEATH AND ELONGATED. THE STENT BROKE AS WELL AS THE TIP OF DELIVERY SYSTEM. SHEATH WAS REMOVED WITH STENT PARTS IN IT. EXCESSIVE FORCE WAS USED DURING WITHDRAWAL. NO DAMAGE TO VESSEL. A NEW STENT WAS DEPLOYED WITHIN ELONGATED STENT. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16655931 ↗
• InjuryAug 22, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT ALONG WITH A NON-MEDTRONIC 6FR 10CM SHEATH DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED, FIBROUS AND PLAQUE LESION IN THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 250MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE OR COMPONENT WAS DETACHED, CRACKED, FRACTURED OR DAMAGED WITH THE DISTAL END OF THE STENT DELIVERY SYSTEM DETACHED FROM THE DELIVERY SYSTEM AT THE PROXIMAL END WHERE STENT ENDS, WHEN BEING REMOVED FROM THE BODY AFTER DEPLOYMENT. THE DETACHED PORTION OF DEVICE DID NOT REMAIN IN PATIENT. THE REMAINING PART OF THE S TENT DELIVERY SYSTEM WAS SNARED OUT OF THE PATIENT FROM THE RADIAL APPROACH. IT IS UNKNOWN IF PRE DILATION WAS CARRIED OUT. IT WAS REPORTED THAT THE PHYSICIAN CROSSED A VERY CALCIFIED, SFA CTO FROM THE PEDAL APPROACH, IT WAS SUBINTIMA AND PLACED MEDTRONIC 6X 200 EVERFLEX STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264384 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT REPRESENTATIVE THAT A PATIENT HAS HAD A RASH EVER SINCE HAVING 2 VISI-PRO BALLOON EXPANDABLE STENTS AND 2 PROTÉGÉ EVERFLEX STENTS IMPLANTED TO TREAT THE LEFT ILIAC AND LEFT SFA AND POPITEAL VESSELS. SYMPTOMS STARTED 1 DAY POST PROCEDURE. THE PHYSICIAN DOESN¿T THINK THERE WAS ANY ISSUES DURING STENT IMPLANTATION. PHYSICIAN DID NOT DETERMINE THE STENTS LED TO PATIENT SYMPTOMS. PATIENT CURRENTLY BEING TREATED WITH CREAM PROVIDED BY DERMATOLOGIST. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Rash

  MAUDE report 14208995 ↗
• InjuryJan 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUED IDENTIFIED. IT WAS REPORTED THAT DURING DELIVERY THROUGH THE VESSEL, DEVICE OR COMPONENT DETACHED, CRACKED FRACTURED OR DAMAGED. THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN PATIENT. ACCESS WAS GAINED THROUGH THE ANKLE AND SNARE WAS USED FOR REMOVAL. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13257446 ↗
• InjuryDec 17, 2021Fracture; Fracture

  A PROTÉGÉ EVERFLEX STENT WAS IMPLANTED TO TREAT A CALCIFIED LESION IN THE PATIENT'S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU AND IMPLANTED FOLLOWING PRE-DILATION WITH A 3X120 DEVICE. THE STENT DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT NOR WAS RESISTANCE ENCOUNTERED DURING ADVANCEMENT. APPROXIMATELY 7 MONTHS POST PROCEDURE IT IS REPORTED THE ORIGINAL STENT HAS MULTIPLE FRACTURES AND SUBSEQUENTLY RESTENOSED. A NEW 6X200 EVERFLEX STENT WAS IMPLANTED INSIDE OF THE FRACTURED STENT. VESSEL OCCLUSION DUE TO RESTENOSIS WITH INTERVENTION RELATED TO THE TARGET VESSEL IS REPORTED. A SECOND 6X60 ENTRUST EVERFLEX WAS IMPLANTED PROXIMAL TO THAT. NO INJURY REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13024741 ↗
• InjuryAug 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE THE PROTEGE SELF EXPANDING STENT ALONG WITH 6FR SHEATH AND NON MEDTRONIC 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE DISTAL LOCATION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA).THE VESSEL WAS MODERATELY TORTUOUS WITH 60% STENOSIS. THE VESSEL DIAMETER WAS 6MM AND LESION LENGTH WAS 200MM. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED PER IFU WITHOUT ANY ISSUES. IT WAS REPORTED THAT THE CATHETER SHEARED OFF AND DETACHED DURING DELIVERY THROUGH THE VESSEL. A SNARE WAS USED TO REMOVE THE DETACHED PORTION FROM THE PATIENT. THE VESSEL WAS PRE-DILATED WITH A 5MM PRE-DILATION DEVICE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. THE PROCEDURE WAS COMPLETED BY DEPLOYING THE STENT AND IT WAS UPON REMOVAL THAT IT WAS NOTICED THAT THE CATHETER HAD SHEERED OFF. THE SHEARED PORTION OF THE CATHETER WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A SNARE. THERE WAS NO NOTED RESISTANCE DURING THE REMOVAL. THERE WAS NO NOTED VESSEL DAMAGE TO THE PATIENT. THERE WERE NO NOTED ISSU

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12360057 ↗
• InjuryFeb 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A PROT G EVERFLEX SELF-EXPANDING STENT WITH A 6FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 260MM CTO (CHRONIC TOTAL OCCLUSION-100%) CALCIFIED, FIBROUS, AND PLAQUE LESION IN THE PATIENT'S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 5MM. MIXED MORPHOLOGY IS REPORTED. SEVERE VESSEL CALCIFICATION 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. THE THUMBSCREW/LOCK PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. PRE-DILATION WAS PERFORMED USING A 5MM PRE-DILUTION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED THAT THE INNER SHEATH THAT HOUSES THE STENT WITH THE RADIOPAQUE MARKERS BROKE OFF THE DEVICE DURING DELIVERY THROUGH THE VESSEL. A LARGER SHEATH WAS PLACED, AND THE INNER CATHETER OF THE STENT WAS SNARED AND RETRIEVED. THE STENT WAS THEN DEPLOYED AND POST-DILATED. NO FURTHER INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11312968 ↗
• InjuryJul 28, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX WITH A NON-MEDTRONIC 6FR SHEATH AND 0.014 SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 175MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF REPORTED DIAMETER 6MM. LESION EXHIBITED 75% STENOSIS. MODERATE VESSEL CALCIFICATION IS REPORTED. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED WITH AN INPACT ADMIRAL DRUG COATED BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. IT IS REPORTED AFTER DEPLOYING THE STENT AND DURING AN ATTEMPT TO REMOVE THE DELIVERY SYSTEM IT BROKE APART. A SNARE WAS USED TO REMOVE THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS DESCRIBED AS BEING SUCCESSFUL WITH NO ADVERSE EVENT REPORTED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331597 ↗
• MalfunctionMar 13, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX DURING TREATMENT OF A LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). IFU WAS FOLLOWED. NO DAMAGE NOTED TO THE PACKAGING PRIOR TO USE. NO ISSUES WHEN REMOVING THE DEVICE FROM THE PACKAGING. DEVICE PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED POST STENT DEPLOYMENT A BREAK/FRACTURE OCCURRED AT THE TIP OF THE DEVICE RESULTING IN IT EMBOLISING IN THE VESSEL. THE PHYSICIAN GAINED TIBIAL ACCESS AND USING THE CATHETER FROM RETROGRADE APPROACH AND PUSHED THE DETACHED TIP UP THROUGH THE ANTEGRADE SHEATH SUCCESSFULLY REMOVING IT. NO ADVERSE EVENT REPORTED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829658 ↗

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