EverFlex™ EVD35-06-150-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00821684051399), received between May 3, 2017 and Sep 30, 2026 — classified as 1 death, 33 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (81 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 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  It was reported that an EVERFLEX ENTRUST stent was being deployed for treatment of an unknown target lesion in the left proximal superficial femoral artery when, during rollback of the dial, the dial broke off the spool wire. The stent was partially deployed at the target site and appeared fractured in the superficial femoral artery. Attempts were made to remove the stent; however, part of the stent became stuck in the sheath. Open surgical cutdown was required to remove the portion of the stent stuck in the sheath. A portion of the stent remained in the patient.

  Patient problems: Insufficient Information

  MAUDE report 50945001 ↗
• MalfunctionJul 7, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  LIMITED INFORMATION REPORTED THAT THE EVERFLEX ENTRUST STENT DELIVERY SYSTEM BROKE UPON STENT DEPLOYMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735907 ↗
• MalfunctionMar 25, 2026Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX ENTRUST FOR TREATMENT OF A 300MM CALCIFIED PLAQUE LESION IN THE PROXIMAL/MID LEFT SUPERFICIAL FEMORAL ARTERY. THERE WAS SEVERE CALCIFICATION WITH CHRONIC TOTAL OCCLUSION. THE ARTERY WAS 6MM IN DIAMETER. A 6FR NON MEDTRONIC SHEATH AND A NITREX GUIDEWIRE WERE USED. THE VESSEL WAS PRE DILATED AND POST DILATED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THERE WAS DIFFICULTY NOTED DURING DEPLOYMENT. THE THUMB WHEEL PROGRESSIVELY BECAME HARD TO TURN THEN POPPED AND FREELY TURNED BUT HAD STOPPED DEPLOYMENT. THE PHYSICIAN DISASSEMBLED THE HOUSING AND MANUALLY DEPLOYED STENT. STENT DEPLOYED SUCCESSFULLY WITHOUT INJURY/INTERVENTION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685557 ↗
• MalfunctionMar 11, 2026Malposition of Device

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID AND DISTAL SEGMENTS OF THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, THE EVERFLEX ENTRUST 6X150X120 STENT WAS PLACED IN THE INCORRECT ANATOMY, THE STENT UNINTENTIONALLY DEPLOYED OUTSIDE OF THE TARGET SITE. THE STENT DEPLOYED MORE MORE PROXIMALLY THAN INTENDED. THE PROCEDURE WAS SUBSEQUENTLY ABORTED. THE SHEATH USED WAS A NON MEDTRONIC 6/7 FRENCH, AND THE GUIDEWIRE WAS A NON MEDTRONIC 0.014. THE VESSEL WAS PRE-DILATED WITH A TURBOHAWK PLUS LX ATHERECTOMY DEVICE AND A 6X200 IN. PACT ADMIRAL DRUG COATED BALLOON, AND POST-DILATED WITH AN AB35W060150135 DEVICE. THERE WAS NO RESISTANCE ENCOUNTERED DURING DEVICE ADVANCEMENT, AND NO ABNORMALITIES WERE NOTED IN THE ANATOMY OR PACKAGING. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568693 ↗
• InjuryJan 30, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 150MM CALCIFIED PLAQUE LESION IN THE PATIENT'S PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, THE EVERFLEX ENTRUST 6X150X120 STENT WAS PARTIALLY DEPLOYED AT THE TARGET SITE. NO VESSEL TORTUOSITY REPORTED. ARTERY DIAMETER REPORTED AS 6MM. THE VESSEL WAS PRE-DILATED PRIOR TO STENT PLACEMENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE PARTIAL DEPLOYMENT RESULTED IN A DELAY IN SURGERY, REQUIRING 45 MINUTES TO REMOVE THE STENT BY SNARING. NO VESSEL DAMAGE REPORTED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220322 ↗
• MalfunctionJan 29, 2026Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING THE EVERFLEX ENTRUST 6X150X120, THERE WAS A 15-MINUTE DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. THE STENT/STRUTS WERE DEFORMED IN VIVO, AND THE DEPLOYED STENT LENGTH WAS MEASURED AT 175-200 MM. ELONGATION OF THE STENT WAS NOTED. DIFFICULTY WAS NOTED DURING DEPLOYMENT, REQUIRING MANUAL PULLBACK ON THE HANDLE TO DEPLOY THE END OF THE STENT. STENT DEPLOYED SUCCESSFULLY WITHOUT INJURY/INTERVENTION. THE WIRE BECAME STUCK IN THE SYSTEM, NECESSITATING REMOVAL OF THE SYSTEM AS A WHOLE. THE PROCEDURE WAS ABORTED. THE PATIENT HAD A 30% STENOSIS, 150 MM LESION LENGTH, AND 5.5 MM ARTERY DIAMETER, WITH MINIMAL TORTUOSITY AND CALCIFICATION. THE VESSEL WAS PRE-DILATED WITH A 4X150 NANOCROSS AND POST-DILATED WITH A 4X120 NANOCROSS. A 6FR SHEATH AND FMD F-14 FLEX GUIDEWIRE WERE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209135 ↗
• MalfunctionJan 5, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING THE EVERFLEX ENTRUST 6X150X120 STENT, PARTIAL DEPLOYMENT OF THE STENT OCCURRED AT THE TARGET SITE WITHIN THE PATIENT¿S VASCULATURE. THE STENT DID NOT FULLY DEPLOY CORRECTLY, AND THE WHEEL MECHANISM BECAME UNATTACHED, PREVENTING FULL DEPLOYMENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT EXCESSIVE FORCE WAS NOT USED. THE STENT DID NOT FULLY COLLAPSE INTO THE SHEATH WHEN TROUBLESHOOTING WAS ATTEMPTED, AND THE END OF THE STENT DETACHED AND WAS DEPLOYED INTO THE RIGHT COMMON FEMORAL ARTERY NEAR THE PATIENT¿S ACCESS SITE. THE PROCEDURE WAS ABORTED, AND THE DELIVERY SYSTEM WAS SAFELY REMOVED (NO INTERVENTION REQUIRED WHEN REMOVING DEVICE FROM PATIENT). THE VESSEL WAS PRE-DILATED WITH A NANOCROSS BALLOON, AND A NON-MEDTRONIC (COOK) 6F SHEATH WAS USED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO VESSEL DAMAGE, PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955018 ↗
• MalfunctionJan 5, 2026Difficult to Remove; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EVERFLEX ENTRUST 6X150X120 STENT FOR TREATMENT OF A CALCIFIED, MODERATELY TORTUOUS LESION WITH 80% STENOSIS AND A LENGTH OF 140 MM IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY, THE DEPLOYMENT WHEEL FROZE AND THE STENT WAS ONLY PARTIALLY DEPLOYED AT THE TARGET SITE WITHIN THE PATIENT VASCULATURE. UPON REMOVAL, THE STENT SUBSEQUENTLY TORE IN HALF. THE PROCEDURE WAS ABORTED, AND THE STENT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. VESSEL PRE-DILATION AND POST-DILATION WERE PERFORMED USING AN EVERCROSS 5 120 DEVICE, AND A 6F NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE WERE USED. NO VESSEL DAMAGE, RESISTANCE DURING DEVICE ADVANCEMENT, OR PACKAGING ISSUES WERE NOTED. LOCK-PINWAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND NO EMBOLIC PROTECTION WAS USED. NO ATTEMPTS WERE MADE TO REMOVE THE STENT PRIOR TO ITS REMOVAL WITH THE DELIVERY SYSTEM. PART OF THE STENT STILL REMAINS IN THE PATIENT. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955007 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED, MODERATE LESION MEASURING 150 MM IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY, THE EVERFLEX ENTRUST DEVICE EXHIBITED A THUMB WHEEL MALFUNCTION AND THE CABLE DETACHED FROM THE BLUE COMPONENT. THE VESSEL WAS PRE-DILATED USING AN IN. PACT ADMIRAL 6X150 MILLIMETER DEVICE AND EMBOLIC PROTECTION WAS USED WITH A 5 MILLIMETER SPIDER DEVICE. WHEN THE PHYSICIAN BEGAN RETRACTING THE SHEATH VIA THE THUMB WHEEL, A LOUD CLICK WAS HEARD. INSTRUCTIONS FOR USE WERE FOLLOWED WITH ISSUE. A WORKAROUND FOR THE THUMB WHEEL MALFUNCTION WAS PROVIDED AND PERFORMED WITHOUT DIFFICULTY, BUT THE CABLE WAS FOUND TO BE DETACHED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE THAT WAS NOT A MEDTRONIC PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450738 ↗
• MalfunctionAug 13, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE INVOLVING THE EVERFLEX ENTRUST 6X150X120, TRACKING DIFFICULTY WAS NOTED. A SECOND EVERFLEX ENTRUST STENT WAS USED. DURING DEPLOYMENT AT THE TARGET SITE WITHIN THE PATIENT VASCULATURE, PARTIAL DEPLOYMENT OCCURRED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE AND WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE STENT REMAINED IN THE PATIENT, AND THE DELIVERY SYSTEM WAS SAFELY REMOVED. THE PROCEDURE WAS COMPLETED USING A THIRD EVERFLEX ENTRUST STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792256 ↗
• MalfunctionJul 4, 2025Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EVERFLEX ENTRUST, DIFFICULTY WAS NOTED DURING DEPLOYMENT IN A HEAVILY CALCIFIED TARGET LESION LOCATED IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. A 5FR NON-MEDTRONIC SHEATH WAS USED. NO RESISTANCE WAS MET DURING ADVANCEMENT OF THE DEVICE. THE PHYSICIAN REPORTED THAT THE STENT FELT DIFFERENT DURING DEPLOYMENT AND NOTED THAT THE GUIDEWIRE "HUNG UP" WHEN BEING REMOVED. THE VESSEL WAS PRE-DILATED WITH EVERCROSS, NON-MEDTRONIC 5 X 40, NANOCROSS 4 X 40, AND A NON-MEDTRONIC 6 X 20, AND POST-DILATED WITH A NANOCROSS 6 X 150. THE STENT WAS DEPLOYED SUCCESSFULLY WITHOUT INJURY OR INTERVENTION, AND NO PATIENT SYMPTOMS, COMPLICATIONS, OR ADVERSE OUTCOMES WERE REPORTED. REVIEWED IMAGES SHOWED STENT SLIGHTLY ELONGATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402220 ↗
• DeathJun 13, 2025Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO TREAT ILIAC ARTERY DISEASE UTILIZING THE DRUG COATED BALLOON 018 IPU06015013P D6.0 L150 UL0130 AND THE EVERFLEX ENTRUST 6X150X120 STENT. DURING THE PROCEDURE, MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES THROUGH THE SEVERELY CALCIFIED AND TORTUOUS RIGHT AND LEFT COMMON ILIAC ARTERIES. EXCESSIVE FORCE WAS USED DURING ADVANCEMENT OF THE DRUG-COATED BALLOON. A 7FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED. A NON-MEDTRONIC INTRAVASCULAR LITHOTRIPSY CATHETER WAS USED FOR VESSEL PRE-DILATION. AN INFLATION DEVICE AND 50/50 CONTRAST INFLATION FLUID WERE USED FOR BALLOON INFLATION. THE DRUG-COATED BALLOON EXPERIENCED DEFLATION DIFFICULTIES DUE TO THE AMOUNT OF CALCIUM PRESENT, RESULTING IN THE BALLOON NOT FULLY DEFLATING AND BECOMING STUCK WITHIN THE VESSEL. NEGATIVE PRESSURE WAS APPLIED IN AN ATTEMPT TO DEFLATE THE BALLOON, BUT IT REMAINED INCOMPLETELY DEFLATED. THE BALLOON SUBSEQUENTLY DETACHED IN THE VESSEL AND WAS REMOVED USING A SNARE. THE EVERFLEX ENT RUST STENT EXPERIENCED A THUMBWHEEL MALFUNCTION, LEADING TO PARTIAL DEPLOYMENT AND THE CATHETER HANDLE WAS DELIBERATELY CRACKED TO AID STENT DE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 22201504 ↗
• MalfunctionMay 23, 2025Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EVERFLEX ENTRUST 6X150X120 STENT, THE THUMBWHEEL ON THE HANDLE WAS NOT FUNCTIONING, PREVENTING FURTHER DEPLOYMENT OF THE STENT. THE PROCEDURE INVOLVED THE USE OF A 6FR X 45CM NON-MEDTRONIC SHEATH AND A 6MM SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE. THE VESSEL WAS PRE-DILATED WITH A 5MM X 220MM NON-MEDTRONIC PTA BALLOON AND A 5MM X 250MM IN. PACT ADMIRAL DRUG COATED BALLOON, AND POST-DILATED WITH A 5MM X 220MM NON-MEDTRONIC PTA BALLOON. THE THUMBSCREW/LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE STENT WAS HALFWAY DEPLOYED AT THE TARGET SITE INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND WHILE THE THUMBWHEEL ON THE HANDLE WAS STILL RETRACTING, THE STENT WAS NOT BEING DEPLOYED ANY FURTHER, WHICH INDICATED AN ISSUE WITH THE STRING ON THE RETRACTOR SHEATH. THE PHYSICIAN NOTED NO DIFFICULTY IN USING THE THUMBWHEEL; ONLY THAT THE STENT WAS PARTIALLY DEPLOYED AND THE THUMBWHEEL WAS NO LONGER WORKING. THE PHYSICIAN DISASSEMBLED THE HANDLE OF THE EVERFLEX ENTRUST SYSTEM AND NOTED THAT THE STRING ATTACHED TO THE THUMBWHEEL WAS NOT CONNECTED TO ANYTHING, MAKING THE NORMAL WORKAROUND DEPLOYMENT STRATEGY IMPOSSIBLE. INSTEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076739 ↗
• MalfunctionJan 15, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EVERFLEX ENTRUST 6X150X120 STENT, THERE WERE DEPLOYMENT ISSUES AS THE STENT WAS INITIALLY UNABLE TO DEPLOY IN THE LEFT SUPERFICIAL FEMORAL ARTERY, SPECIFICALLY AT THE MID AND DISTAL LOCATIONS. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE THUMBSCREW/LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE TARGET LESION WAS CHARACTERIZED BY PLAQUE WITH MINIMAL TORTUOSITY, MODERATE CALCIFICATION, 60% STENOSIS, AND A LENGTH OF 120 MILLIMETERS. THE ARTERY DIAMETER WAS 6 MILLIMETERS. THE PROCEDURE INVOLVED PRE-DILATION WITH A HAWKONE LX ATHERECTOMY DEVICE AND A 5X60 EVERCROSS BALLOON, FOLLOWED BY POST-DILATION WITH AN EVERCROSS 6X120 BALLOON. A 6X55 NON-MEDTRONIC SHEATH AND A 014 NON-MEDTRONIC GUIDEWIRE WERE USED. DESPITE THE INITIAL DEPLOYMENT ISSUE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER ADVISING THE PHYSICIAN ON A WORKAROUND TO RELEASE THE STENT, RESULTING IN ITS SUCCESSFUL DEPLOYMENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED FROM THE PATIENT. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159615 ↗
• MalfunctionNov 25, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX ENTRUST FOR THE TREATMENT OF A 300 MM CALCIFIED LESION WITH TOTAL OCCLUSION OF PROXIMAL REGION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 5 MM IN DIAMETER. THE VESSEL WAS PRE-DILATED WITH AN EVERCROSS PTA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE MET DURING ADVANCEMENT. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED AT THE TARGET LESION AND THE THUMB WHEEL WOULD NO LONGER TURN, THE PHYSICIAN MANUALLY OPENED THE DEVICE AND THE BACK STRING WAS PULLED TO FINISH DEPLOYMENT. ONCE THE DEPLOYMENT STRING WAS PULLED STENT WAS FULLY DEPLOYED IN CORRECT SPOT AND PROCEDURE WAS COMPLETE. NO DEFORMATION NOTED TO THE DEPLOYED STENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770597 ↗
• MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE 2 EVERFLEX ENTRUST STENTS TO TREAT A FIBROUS LESION IN THE RIGHT PROXIMAL MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF CALCIFICATION WAS MINIMAL. ARTERY/VEIN DIAMETER WAS 4.5-5.5 MM. A TERUMO 5FR DESTINATION WAS USED. A BLACK SION .014 WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE FIRST STENTS NOSECONE TIP (MOST DISTAL PART OF CATHETER) DETACHED IN VIVO WITHIN SHEATH. IT DID NOT BREAK OFF, IT SEPARATED. DETACHED COMPONENT WAS SAFELY REMOVED FROM THE PATIENT. THE SECOND STENT DEFORMED WITH STENT/STRUTS DEFORMED IN VIVO DURING POSITIONING. THERE WAS NO PATIENT INJURY BUT THE STENT ELONGATED AND HAD TO BE SNARED OUT. THE STENT WAS 500 MM, ELONGATED BUT INTACT. A NEW EVERFLEX ENTRUST WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE, THIRD STENT WAS USED TO TREAT PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20743241 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO INPACT ADMIRAL DCBS AND AN EVERFLEX ENTRUST STENT WERE USED TO TREAT THE LEFT SUPERFICIAL FEMORAL PROXIMAL AND SUPERFICIAL FEMORAL MIDDLE VESSELS. DURING A REVASCULARIZATION PROCEDURE TWO INPACT ADMIRAL DCBS AND AN EVERFLEX ENTRUST STENT WERE USED TO TREAT THE RIGHT SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE AND SUPERFICIAL FEMORAL DISTAL VESSELS. 18 MONTHS POST INDEX PROCEDURE TWO AREAS OF IN-STENT STENOSIS WERE NOTED DURING ANGIOGRAM AND IT WAS DECIDE TO PROCEED WITH INTERVENTION. PATIENT WAS TREATED WITH INTERVENTION OF THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL PROXIMAL, SUPERFICIAL FEMORAL MIDDLE, SUPERFICIAL FEMORAL DISTAL VESSELS WITH TWO INPACT 018 DCB. THE PATIENT IS RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS RELATED TO DEVICE AND NOT RELATED TO THE PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 20726853 ↗
• InjuryNov 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE 2 EVERFLEX ENTRUST STENTS TO TREAT A FIBROUS LESION IN THE RIGHT PROXIMAL MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF CALCIFICATION WAS MINIMAL. ARTERY/VEIN DIAMETER WAS 4.5-5.5MM. A TERUMO 5FR DESTINATION WAS USED. A BLACK SION .014 WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE FIRST STENTS NOSECONE TIP DETACHED IN VIVO WITHIN SHEATH. IT DID NOT BREAK OFF, IT SEPARATED. DETACHED COMPONENT WAS SAFELY REMOVED FROM THE PATIENT. THE SECOND STENT DEFORMED WITH STENT/STRUTS DEFORMED IN VIVO DURING POSITIONING. THERE WAS NO PATIENT INJURY BUT THE STENT ELONGATED AND HAD TO BE SNARED OUT. THE STENT WAS 500MM, ELONGATED BUT INTACT. A NEW EVERFLEX ENTRUST WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674818 ↗
• MalfunctionOct 8, 2024Activation, 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

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A .035 NON-MEDTRONIC (SUPRACORE ABBOTT WIRE) GUIDEWIRE DURING TREATMENT OF A 120MM CALCIFIED LESION IN THE PATIENT¿S LEFT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL ARTERY. MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 95% STENOSIS. ARTERY DIAMETER REPORTED AS 5.5MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. TORTUOUS AORTIC BIFURCATION WAS REPORTED. 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-DILATED WITH 4X120, 5X200, AND 6X200 EVERCROSS PTA BALLOONS. THE VESSEL WAS POST-DILATED WITH A 5MM EVERCROSS PTA BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PHYSICIAN USED LIVE FLOURO WHILE HE TRACKED THE STENT THROUGH THE SHEATH AND OVER THE BIFURCATION. THE STENT WAS ABLE TO TRACK AND GET POSITIONED AT THE TA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394859 ↗
• MalfunctionOct 7, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX ENTRUST FOR TREATMENT OF A PLAQUE LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER. THE IFU WAS FOLLOWED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED DURING USE IN THE PATIENT THE CATHETER HANDLE WAS DELIBERATELY CRACKED TO AID STENT DEPLOYMENT AND THE STENT DEPLOYED IN THE TARGET LOCATION. THE DELIVERY SYSTEM WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383534 ↗
• MalfunctionAug 28, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN EVERFLEX ENTRUST WAS BEING USED FOR TREATMENT OF A 120MM CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE CALCIFICATION. THE IFU WAS FOLLOWED. THE VESSEL WAS PRE-DILATED. THE DEVICE DID NO PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE AND REMOVED PRIOR TO DEPLOYMENT ATTEMPT. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED, IN ORDER TO FULLY DEPLOY THE STENT THE PHYSICIAN REMOVED THE PLASTIC AND PIN AND PULLING SYSTEM. THE DELIVERY SYSTEM WAS SAFELY REMOVED AND NO OTHER ACTIONS WERE TAKEN AS A RESULT OF THE PRE-DEPLOYMENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084259 ↗
• MalfunctionAug 20, 2024Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  AN EVERFLEX ENTRUST WAS BEING IMPLANTED FOR TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. A 7FR SHEATH AND A 0.014 NON MEDTRONIC GUIDEWIRE WERE USED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED WITHOUT ISSUE. NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT THE DEVICE PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS SLIGHT RESISTANCE WHEN ADVANCING THE DEVICE. THE STENT WAS DEPLOYED SUCCESSFULLY AND REMAINS IMPLANTED IN THE PATIENT. THE DELIVERY SYSTEM WAS REMOVED SUCCESSFULLY WITHOUT INJURY/INTERVENTION. NO PATIENT CONSEQUENCES OR INJURY REPORTED. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE DELIVERY SYSTEM WAS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006579 ↗
• MalfunctionApr 2, 2024Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO IMPLANT AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER REPORTED AS 6MM. 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. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED AT THE TARGET SITE WITHIN THE PATIENT VASCULATURE. THE THUMBSCREW/LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE STENT ENDED UP DEPLOYING FULLY BY PIN-AND-PULL ACTION AFTER REMOVAL OF THE HANDLE. THE STENT REMAINS IN THE PATIENT. THERE WERE NO ATTEMPTS MADE TO REMOVE THE STENT. NO DEFORMATION WAS NOTED TO THE DEPLOYED STENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. NO VESSEL DAMAGE REPORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021052 ↗
• MalfunctionMar 5, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 6FR NON-MEDTRONIC SHEATH AND A .035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 130MM CALCIFIED LESION IN THE PATIENT¿S RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED 90% STENOSIS. ARTERY DIAMETER IS 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. NO ISSUES WERE 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 NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THE STENT WAS UNABLE TO DEPLOY. THE THUMBSCREW LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE THUMBSCREW LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. STENT STRUTS WERE EXPOSED/VISIBLE ON REMOVAL. NO INTERVENTION REQUIRED FOR REMOVAL OF DEVICE. THE DEVICE WAS SAFELY REMOVED FROM PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835355 ↗
• MalfunctionDec 4, 2023Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING TREATMENT OF A LESION IN THE PATIENT¿S MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). NO VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 80% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THE WHEEL BROKE DURING DEPLOYMENT AND STENT NEVER FULLY DEPLOYED. DEVICE NEVER IMPLANTED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. A REPLACEMENT EVERFLEX STENT OF THE SAME SIZE WAS PULLED AND USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255192 ↗

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