EverFlex™ EVD35-07-150-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00821684051474), received between Oct 5, 2017 and Aug 12, 2026 — classified as 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (23 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Difficult to Remove; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  It was reported that during treatment of critical limb ischemia with rest pain in the left lower extremity, an EVERFLEX ENTRUST 7 x 150 x 120 stent was used to treat a calcified chronic total occlusion in the proximal left superficial femoral artery, with stent placement for dissection. The target vessel diameter was 6 mm, with severe lesion calcification and moderate tortuosity. A hostile aortic bifurcation was reported, with multiple episodes of sheath prolapse during the procedure. The vessel was pre-dilated with a 5 mm x 200 mm Sterling balloon, and the instructions for use were followed without issue. After approximately 6 cm of stent deployment, the thumb wheel became difficult to rotate and subsequently locked. Troubleshooting by opening the delivery-system handle was attempted; however, tremendous resistance was encountered while retracting the silver inner sheath. The entire system was attempted to be removed which stretched the stent from the proximal SFA across the SFA and into the distal EIA.  A femoral cutdown was needed to remove the stent. The EIA and CFA portions were removed but the proximal SFA segment was left behind. This segment was later refined with a covered

  Patient problems: Insufficient Information

  MAUDE report 50219833 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EVERFLEX ENTRUST 7X150X120 DEVICE WAS ASSOCIATED WITH AN ALLEGATION OF CATHETER HANDLE SEPARATION, WITH THE TIMING OF THE SEPARATION REPORTED AS UNKNOWN. THE DEVICE WAS NEVER IMPLANTED. THE INSTRUCTIONS FOR USE WERE REPORTED TO HAVE BEEN FOLLOWED WITHOUT ISSUE, AND NO DAMAGE TO THE PACKAGING OR ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY WERE REPORTED. EMBOLIC PROTECTION WAS NOT USED. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394590 ↗
• MalfunctionMar 19, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A PLAQUE LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING THE EVERFLEX ENTRUST 7X150X120, THERE WAS A ONE-HOUR DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. CATHETER/HANDLE SEPARATION OCCURRED DURING USE IN THE PATIENT, AND THE DEPLOYMENT WIRE SNAPPED. STENT/STRUTS WERE NOTED TO BE DEFORMED IN VITRO. THE STENT BECAME DEPLOYED INSIDE THE BODY EVEN WHILE THE RED TAB WAS IN PLACE. THE DEVICE COULD NOT BE SAFELY REMOVED AND HAD TO BE DEPLOYED. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638696 ↗
• MalfunctionSep 19, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST STENT DURING A PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL-MID SUPERFICIAL FEMORAL ARTERY. THERE WAS NO DAMAGE NOTED TO PACKAGING, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU WAS FOLLOWED WITHOUT ISSUE. A NON MEDTRONIC 5FR 45CM SHEATH WAS USED AND A NON-MEDTRONIC .014 GUIDEWIRE WAS USED. DIFFICULTY NOTED DURING DEPLOYMENT OF EVERFLEX ENTRUST WAS REPORTED. THE STENT WOULD NOT DEPLOY WITH WHEEL, WIRE WAS STUCK AND DOCTOR LOST WIRE ACCESS. THE STENT WAS SAFELY REMOVED FROM THE PATIENT UNDEPLOYED. A NEW EVERFLEX ENTRUST WAS USED AND DIFFICULTY WAS NOTED DURING DEPLOYMENT AND THE STENT WOULD NOT DEPLOY WITH WHEEL. THE STENT WAS SAFELY REMOVED FROM THE PATIENT. A NEW EVERFLEX ENTRUST WAS THEN USED WHICH HAD TO BE DEPLOYED MANUALLY AS THUMBWHEEL BROKE, DEVICE CATHETER WAS REMOVED WITH THE STENT IMPLANTED. ANOTHER STENT WAS NEEDED TO COVER THE REST OF THE LESION AND THIS STENT DID NOT EXPERIENCE DEPLOYMENT ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20254849 ↗
• InjuryApr 10, 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 45CM 6FR NON-MEDTRONIC (TERUMO DESTINATION) SHEATH AND A 260CM NON-MEDTRONIC (TERUMO ADVANTAGE) GUIDEWIRE DURING TREATMENT OF A 15MM CALCIFIED LESION IN THE PATIENT¿S LEFT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. TORTUOUS AT SITE OF LESION WITH CALCIFICATION. 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. EMBOLICPROTECTION WAS NOT USED. THE VESSEL WAS PRE DILATED WITH A 5X80X120 CHOCOLATE PTA BALLOON AND A 6X120X130 INPACT ADMIRAL DCB BALLOON. THE VESSEL WAS POST-DILATED WITH A 6X120X130 INPACT ADMIRAL DCB BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. MINIMAL RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. CATHETER/HANDLE SEPARATION DURING USE IN THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077798 ↗
• InjurySep 8, 2023Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX ENTRUST FOR THE TREATMENT OF A 120MM CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A 6FR SHEATH WAS USED. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE SYSTEM WAS DEPLOYED FOR 75% AND THE THUMBWHEEL GOT STUCK. THE LENGTH OF THE DEPLOYED STENT IN THE VESSEL WAS 150MM. STENT DISLODGEMENT OCCURRED. THE DISLODGED STENT WAS NOT REMOVED, AFTER IT FLOWERED IT WAS NOT REPOSITIONED. THE DEPLOYMENT CATHETER WAS REMOVED AND THE STENT WAS ELONGATED. THE PHYSICIAN COMPLETED THE PROCEDURE, AN UNKNOWN STENT WAS USED AFTER THE MEDTRONIC STENT WAS DEPLOYED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710426 ↗
• MalfunctionJun 30, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX ENTRUST FOR THE TREATMENT OF A CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS SEVERELY TORTUOUS AND MODERATELY CALCIFIED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED WITH A 018 DRUG COATED BALLOON (DCB), THEN TWO 7X150 NON MEDTRONIC STENT WERE ATTEMPTED TO BE DELIVERED AND DEPLOYED WITH NO SUCCESS. THE PHYSICIAN THEN DELIVERED THE EVERFLEX WITH RESISTANCE MET DURING DELIVERY TO THE LESION AND FORCE WAS APPLIED. THE PIN WAS REMOVED PRIOR TO DEPLOYMENT. THE STENT PARTIALLY DEPLOYED AND THE HANDLE WAS THEN CRACKED OPEN AND A CLAMP WAS USED TO DEPLOY THE REMAINDER OF THE STENT. THE PHYSICIAN ADDED TWO MORE STENTS ABOVE IN THE MID AND PROXIMAL REGIONS OF THE VESSEL. ALL 3 STENTS WERE POST DILATED WITH A 5X 80 BALLOON. PHYSICIAN BELIEVES THE ISSUE OCCURRED AS A RESULT OF PATIENTS ANATOMY ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236553 ↗
• MalfunctionJun 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING TREATMENT OF A LESION IN THE PATIENTS DISTAL ARTERY/VEIN. EMBOLIC PROTECTION WAS USED. 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 PER THE IFU WITH NO ISSUES IDENTIFIED. IT IS REPORTED THE HANDLE BROKE DURING PREPARATION, THE HANDLE BROKE AFTER VESSEL WAS PREPARED FOR PROCEDURE BUT BEFORE THE DEVICE WAS DEPLOYED. DEVICE NEVER DEPLOYED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. A REPLACEMENT DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17141947 ↗
• MalfunctionJun 6, 2023Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX ENTRUST FOR TREATMENT OF A 130MM PLAQUE LESION IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER WAS 6MM WITH MODERATE CALCIFICATION AND TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO EMBOLIC PROTECTION WAS USED. A 6FR NON MEDTRONIC SHEATH WAS USED. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. IT WAS REPORTED WHILE RETRACTING THE THUMB WHEEL PHYSICIAN A SNAP WAS HEARD AND WAS UNABLE TO CONTINUE TO DEPLOY STENT. THE PHYSICIAN GENTLY REMOVED DEVICE ALLOWING FOR STENT TO BE DEPLOYED. STENT ELONGATION OCCURRED, AN ANGIO WAS TAKEN OF THE IMPLANTED STENT AND HE DECIDED TO LEAVE ALONE. IT WAS REPORTED THE PATIENT HAD MULTIPLE INTERVENTIONS, THE PATIENT HAD SEVERAL BTK INTERVENTIONS WHICH WAS NOT A RESULT OF THE IMPLANTED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070419 ↗
• MalfunctionMay 11, 2023Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN USED AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A NON-MEDTRONIC (TERUMO SLENDER) SHEATH AND A 0.035 GUIDEWIRE DURING TREATMENT OF A 150MM PLAQUE LESION IN THE PATIENT¿S LEFT PROXIMAL MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL ARTERY, TIBIAL/POPLITEAL TRUNK & ANTERIOR TIBIAL ARTERY. ARTERY DIAMETER IS REPORTED AS 4-7MM. LITTLE VESSEL CALCIFICATION AND NO VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 0-15% STENOSIS. NO EMBOLIC PROTECTION WAS 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. PRE-DILATION WAS PERFORMED USING A 5X120 EVERCROSS DILATATION CATHETER. THE STENT WAS DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. THIS CASE WAS PEDAL ACCESS. UPON THE FIRST APPROXIMATE 30 MM OF THE STENT¿S DEPLOYMENT THE TOGGLE WHEEL ¿SNAPPED/BROKE¿ AND THE WHEEL SPUN FREELY. MANUAL DEPLOYMENT OF THE STENT WAS INITIATED AND THE STENT WAS DEPLOYED IN THE VESSEL BED(S). UPON INITIATION OF MANUAL DEPLOYMENT IT WAS NOTICED THAT THE TOGGLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911079 ↗
• MalfunctionMar 2, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING PATIENT TREATMENT. IT WAS REPORTED THAT THERE WAS PARTIAL DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER MEDTRONIC ENTRUST WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466172 ↗
• MalfunctionNov 15, 2022Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX ENTRUST FOR TREATMENT OF A 120MM LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 6FR NON-MDT SHEATH AND A 0.014" NON-MDT GUIDEWIRE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES NOTED. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED. THE THUMB-WHEEL FAILED MID-DEPLOYMENT. THE PHYSICIAN PULLED BACK THE ENTIRE STENT DELIVERY SYSTEM WHICH DEPLOYED THE REST OF THE STENT IN THE TARGET LOCATION. THE STAFF WERE TRAINED ON THE IFU CHANGES AND TECHNIQUE ON OPENING THE HANDLE TO MANUALLY DEPLOY THE STENT. WIRE ACCESS ACROSS THE STENT WAS LOST DURING REMOVAL. NO PATIENT INJURY OCCURRED AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796044 ↗
• MalfunctionSep 29, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH THE ENTRUST DELIVERY SYSTEM IN A CALCIFIED SFA. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE VESSEL WAS PRE-DILATED. THE LOCK-PIN WAS REMOVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO EXCESSIVE FORCE USED. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED. AFTER MULTIPLE ATTEMPTS THE STENT WAS FULLY DEPLOYED USING THE ENTRUST SYSTEM. THE HANDLE WAS NOT CRACKED OPEN TO MANUALLY DEPLOY THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504924 ↗
• MalfunctionAug 22, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A 5FR SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED FIBROUS LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS MODERATELY TORTUOUS. 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. PARTIAL DEPLOYMENT WAS NOTED WITH NO DAMAGE TO DEPLOYMENT MECHANISM REPORTED.. THE LOCK-PIN WAS REMOVED BEFORE ENTERING THE SHEATH. THE LESION WAS PRE DILATED WITH A 6MM DEIVCE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT DURING DEPLOYMENT, THE STENT WOULD ONLY PARTIALLY DEPLOY. THE HANDLE WAS THEN OPENED UP TO ALLOW PHYSICIAN TO MANUALLY DEPLOY THE REST OF THE ST ENT. STENT CATHETER WAS REMOVED WITHOUT INCIDENT. POST DILATATION WAS PERFORMED WITH A 6MM BALLOON. NO INJURY TO THE PATIENT NOR ANY PRODUCT LEFT BEHIND IN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264188 ↗
• MalfunctionJul 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A SPIDER FX EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED, THE RED SAFETY TAB BROKE FROM THE HANDLE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED, BUT ONLY A PORTION WAS REMOVED. THE REST BROKE OFF AND STAYED IN HANDLE. THE VESSEL WAS PRE DILATED WITH A 4X120 RAPIDCROSS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE HANDLE OF THE DEVICE WAS CRACKED OPEN, AND THE PHYSICIAN USED CLAMPS TO PULL BACK OUTER SHEATH TO DEPLOY THE STENT. THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984283 ↗
• MalfunctionJun 10, 2022Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. 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. DEPLOYMENT ISSUE OCCURRED WITH THE STENT PARTIALLY DEPLOYED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED AT TIME OF DEPLOYMENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT PHYSICIAN HAD TO CRACK OPEN DELIVERY SYSTEM DEPLOYMENT HANDLE AND MANUALLY PULL BACK THE SYSTEM TO DEPLOY THE STENT. THERE WAS NO COMPLICATION ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653501 ↗
• InjuryMay 17, 2022Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A NON-MEDTRONIC 6FR. SHEATH AND NON-MEDTRONIC 0.014 GUIDEWIRE DURING TREATMENT OF AN 8-10CM PLAQUE LESION IN THE PATIENT'S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. NO TORTUOSITY AND MODERATE CALCIFICATION REPORTED. EMBOLIC PROTECTION WAS NOT USED. PRE-DILATION WAS NOT PERFORMED. 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 DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND REMOVED PRIOR TO DEPLOYMENT ATTEMPT. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT WITH NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT. DEPLOYMENT DIFFICULTIES ARE REPORTED. PHYSICIAN USED THE THUMBWHEEL FOR DEPLOYMENT BUT THE STENT WAS NOT FULLY DEPLOYED, APPROXIMATELY 50MM DEPLOYED. DURING THE PHYSICIAN'S ATTEMPT TO REMOVE THE PARTIALLY DEPLOYED STENT, STENT DISLODGEMENT OCCURRED. PARTIAL EXPLANT OF THE STENT WAS COMPLETED WITH THE STENT REMOVED FROM THE PATIENT WITH THE MARKERS DISLODGED. A NEW STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO PATI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14414690 ↗
• MalfunctionJan 19, 2022Malposition of Device; Activation, Positioning or Separation Problem; Material Deformation; Malposition of Device; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERFLEX ENTRUST SELF EXPANDING STENT DURING PROCEDURE TO TREAT LITTLE CALCIFIED PLAQUE IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD NO TORTUOSITY. THE ARTERY DIAMETER WAS 6MM AND LESION LENGTH WAS 150MM. A NON MEDTRONIC 6FR SHEATH WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/DEPLOYMENT. THE LENGTH OF DEPLOYED STENT WAS SUPPOSED TO BE 150MM. THERE WAS INACCURATE DELIVERY I.E. STENT DEPLOYED IN UNINTENDED LESION SITE. THERE WAS NO DAMAGE TO DEPLOYMENT MECHANISM OR DEVICE HANDLE PRIOR TO DEPLOYMENT. THE THUMBSCREW/LOCK PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE RED SAFETY STOP WAS NOT COMPLETELY REMOVED/ONLY PARTIAL 'STILL HANGING LOOSELY' WHEN DEPLOYMENT BEGAN. STENT STARTED TO DEPLOY BUT WOULD NOT COMPLETE DEPLOYMENT. PHYSICIAN HAD TO PULL ON THE DELIVERY DEVICE IN ATTEMPT TO COMPLETE DEPLOYMENT. THIS CAUSED STENT STRETCH/ELONGATION AND LED TO STENT BEYOND WHAT WAS INTENDED AND COVERING CFA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287945 ↗
• MalfunctionApr 20, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GLIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY WITH 75% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 140MM RESPECTIVELY. 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. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/DEPLOYMENT. DEPLOYMENT ISSUE OCCURRED WITH STENT UNABLE TO DEPLOY. THERE WAS RESISTANCE ENCOUNTERED DURING DELIVERY TO LESION WITH NO FORCE APPLIED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE THUMBSWITCH WAS CHECKED FOR SECUREMENT PRIOR TO USE. THE LOCK-PIN WAS REMOVED JUST PRIOR TO DEPLOYMENT. THE VESSEL WAS NOT PRE DILATED. IT WAS REPORTED THAT ROTATING WHEEL WOULD NOT DEPLOY THE 7X150 STENT FULLY. DELIVERY SYSTEM WAS PULLED BACK HOPING TO DEPLOY THE STENT. IT ELONGATED THE STENT AND THEN RELEASED FROM DELIVERY. AN ADDITIONAL 7X100 ENTRUST WAS THEN DEPLOYED WITHIN THE 7X150 S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692327 ↗
• MalfunctionJun 23, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENT¿S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. MODERATE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. A STEEP AORTIC ILIAC CALCIFIED BIFURCATION IS REPORTED. ATHERECTOMY WAS PERFORMED PRIOR TO TREATMENT WITH STENT. IT WAS REPORTED THAT THE STENT WAS ATTEMPTED TO BE USED BUT IT WAS NOT DEPLOYED DUE TO DEVICE FAILURE. LOCK PIN WAS REMOVED PRIOR TO DEPLOYMENT ATTEMPT. NO REAL UNUSUAL FORCE WAS FELT DURING DEPLOYMENT ATTEMPT. NO PARTIAL DEPLOYMENT WAS OBSERVED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND IT WAS REPLACED BY A NEW EVERFLEX ENTRUST OF SAME MODEL AND LOT NUMBER. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183901 ↗
• MalfunctionMay 5, 2020Malposition of Device; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Malposition of Device; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENT¿S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. MODERATE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. A STEEP AORTIC ILIAC CALCIFIED BIFURCATION IS REPORTED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED DURING THE PROCEDURE. ATHERECTOMY WAS PERFORMED PRIOR TO TREATMENT WITH STENT. THE EVERFLEX ENTRUST WAS ADVANCED WITH RESISTANCE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. DURING ATTEMPTED DEPLOYMENT OF THE STENT, THE PHYSICIAN NOTED THUMB WHEEL DIFFICULTY ROLLING BACK. SOME PRESSURE WAS APPLIED LEADING TO SEPARATION ON THE CATHETER. A PORTION OF THE DETACHED CATHETER WAS STILL ON WIRE AND OUTSIDE OF BODY, SO IT WAS JUST PULLED WITH NO RESISTANCE FROM PHYSICIAN. IT IS REPORTED THAT THERE WAS INACCURATE DELIVERY OF THE STENT WITH IT DEPLOYING IN AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10023747 ↗
• MalfunctionApr 15, 2020Fracture; Activation, Positioning or Separation Problem; Difficult to Advance; Fracture; Activation, Positioning or Separation Problem; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH A 5FR SHEATH AND A NON MEDTRONIC .035 GUIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT PROXIMAL TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 85% STENOSIS. THE VESSEL IS SEVERELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 150MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES IDENTIFIED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU. DURING DELIVERY THROUGH THE VESSEL STENT FRACTURE OCCURRED DURING STENT DEPLOYMENT. THE DEVICE DID NOT EMBOLIZE. THE WHOLE STENT STAYED ON THE DELIVERY SYSTEM IT CAME OUT AS ONE. THE LESION WAS PRE DILATED WITH A NON MEDTRONIC PTA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHILE ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE. IT WAS REPORTED THAT PATIENT HAD A VERY TORTUROUS AORTA BIFURCATION. WHEN STENT REACH TARGET LESION AND STARTING TO DEPLOY, THE STENT DELIVERY SYSTEM GOT STUCK AND WOULD NOT DEPLOY. THE WHEEL THAT DELIVERS THE STENT STOPPED TURNING AND STENT WOULD NOT DEPLOY. STENT AND DELIVERY SYSTEM WERE ALL STUCK WIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962064 ↗
• MalfunctionOct 24, 2019Fracture; Fracture

  PATIENT HAD AN EVERFLEX ENTRUST AND A PROTEGE EVERFLEX STENT(S) IMPLANTED TO TREAT A 300MM LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. PROCEDURE WAS CARRIED OUT AS PER IFU WITHOUT ISSUE. LESION WAS PRE-DILATED. IT IS REPORTED THAT APPROXIMATELY 11 MONTHS POST PROCEDURE, THE PATIENT PRESENTED FOR ANGIO DUE TO LEG PAIN AND A STENT FRACTURE WAS IDENTIFIED. THE STENTS WAS OBSERVED TO BE FRACTURED IN TWO PLACES. IT IS UNKNOWN WHICH STENT FRACTURED. PATIENTS CONDITION IS STABLE. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WILL BE REQUIRED - NONE REPORTED TO DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9231513 ↗
• MalfunctionOct 1, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX SE STENT IN THE SFA. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT DEPLOYMENT ISSUE OCCURRED. THE LAST CENTIMETER OF THE STENT WAS NOT DEPLOYNG DESPITE THE CONTINUING RATCHET OF THE THUMB WHEEL. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT. THE LOCK-PIN WAS REMOVED RIGHT BEFORE DEPLOYMENT. PHYSICIAN HAD TO PULL THE STENT CATHETER BACK THROUGH THE SHEATH TO RELEASE THE FINAL CENTIMETER OF THE STENT FROM THE DELIVERY CATHETER. THERE WAS ENOUGH FRICTION FROM THE PREVIOUS 14CM OF THE STENT BEING ADHERED TO THE VESSEL WALL AND WAS ABLE TO RELEASE THE LAST CENTIMETER BY PULLING ON IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9138836 ↗
• MalfunctionAug 8, 2019Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN USED AN EVERFLEX ENTRUST WITH A 6FR SHEATH AND .035 GUIDEWIRE DURING TREATMENT OF A 60MM CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. SEVERE TORTUOSITY (AT AORTIC COMMON ILIAC BIFURCATION) AND MODERATE CALCIFICATION IS REPORTED. ABNORMALITIES IN RELATION TO PATIENT ANATOMY ARE DESCRIBED AS AORTIC STENT GRAFT AN AORTA-ILIAC BIFURCATION. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. PRE-DILATION WAS PERFORMED WITH A 5X150 PTA BALLOON. THE DEVICE WAS ADVANCED TO THE TARGET AREA WITHOUT ISSUE. DEVICE NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE THUMBWHEEL ON THE EVERFLEX ENTRUST IS REPORTED TO HAVE BROKEN MID-DEPLOYMENT. AS THE DISTAL END OF THE STENT WAS DEPLOYED, THE PHYSICIAN HAD TO PIN THE WIRE AND PULL STENT CATHETER BACK ALLOW STENT TO FURTHER DEPLOY. THE STENT WAS ELONGATED POST DEPLOYMENT. IT IS REPORTED THAT 200MM OF THE STENT WAS DEPLOYED IN THE VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874028 ↗

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