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

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00821684051634), received between Sep 21, 2017 and Dec 22, 2025 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (19 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EVERFLEX ENTRUST 6X150X150, THERE WAS PARTIAL DEPLOYMENT AT THE TARGET SITE WITHIN THE PATIENT VASCULATURE. THE STENT DID NOT REMAIN IN THE PATIENT AND WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION (DEPLOYMENT THUMB WHEEL WOULD NOT MOVE DESCRIBED AS STUCK). THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT AND REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. NO VESSEL DAMAGE OCCURRED, AND NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, OR DEATHS WERE REPORTED. THE STENT MALFUNCTIONED AND WAS REMOVED BECAUSE IT WOULD NOT FULLY DEPLOY. DEPLOYMENT THUMB WHEEL WOULD NOT MOVE DESCRIBED AS STUCK GOT SO THEY REMOVED THE STENT AND STENT ENTRUST DELIVERY SYSTEM TOGETHER. THE PATIENT OUTCOME WAS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT IS MENTIONED THAT INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 23862960 ↗
• MalfunctionAug 13, 2025Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  LIMITED INFORMATION REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, THE EVERFLEX ENTRUST SELF-EXPANDING PERIPHERAL STENT DELIVERY SYSTEM MALFUNCTIONED. THE STENT COULD NOT BE REMOVED AFTER THE ATTEMPTED DEPLOYMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792192 ↗
• MalfunctionJun 10, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A SOFT TISSUE LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY WITH THE EVERFLEX ENTRUST 6X150X150 STENT, DIFFICULTY WAS NOTED DURING DEPLOYMENT. THE HANDLE WAS DELIBERATELY BROKEN AND THE STENT WAS MANUALLY DEPLOYED USING THE PIN AND PULL METHOD. A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS PRE-DILATED WITH AN EVERCROSS 3X100 BALLOON AND POST-DILATED WITH AN EVERCROSS 5X100 BALLOON. THE STENT WAS SUCCESSFULLY DEPLOYED AND REMAINS IMPLANTED. THE DELIVERY SYSTEM 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 22175857 ↗
• MalfunctionFeb 22, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN EVERFLEX ENTRUST WAS INTENDED TO BE IMPLANTED FOR THE TREATMENT OF A CALCIFIED LESION IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY POPLITEAL ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 5MM PRE-DILATION DEVICE. THE LOCK-PIN WAS CHECKED FOR SECUREMENT AND THEN REMOVED PRIOR TO DEPLOYMENT OF THE STENT. THERE WAS NO RESISTANCE DURING DELIVERY TO THE LESION AND THE DEVICE PASSED THOUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE DEVICE COULD NOT BE DEPLOYED. THE STENT SYSTEM AND 0.014 NON MEDTRONIC WIRE WERE REMOVED AS A UNIT. DEVICE WAS SAFELY REMOVED FROM PATIENT AND INTERVENTION WAS REQUIRED. NO PATIENT INJURY. STENT STRUTS WERE VISIBLE UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764058 ↗
• InjuryFeb 16, 2024Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX ENTRUST DURING TREATMENT OF A LESION IN THE PROXIMAL REGION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 6MM BALLOON. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT.  THE DEVICE  WAS BACKLOADED OVER THE 0.035" GUIDEWIRE. THE PHYSICIAN ADVANCED THE DEVICE INTO POSITION WITHIN THE RIGHT SFA AND REMOVED AND DISCARDED THE LOCKING PIN. THE PHYSICIAN SLOWLY ROTATED THE THUMBWHEEL AND THE STENT STARTED TO DEPLOY. AFTER A PORTION OF THE STENT WAS DEPLOYED, IT WAS NOTED THAT THE THUMBWHEEL WAS ROTATING BUT THE STENT WAS NO LONGER BEING DEPLOYED. THE PHYSICIAN WAS INSTRUCTED TO OPEN THE HOUSING THAT CONTAINED THE THUMBWHEEL AND TO USE THE DEPLOYMENT SYSTEM AS A "PINCH AND PULL DEPLOYMENT SYSTEM". AFTER STARTING THE "PINCH AND PULL", THE PHYSICIAN NOTED THAT THE STENT WAS MIGRATING PROXIMALLY. AT THIS POINT, IT WAS DECIDED TO ABORT THE DEPLOYMENT OF THE STENT. A VASCULAR SURGEON WAS CALLED TO TAKE THE PATIENT WENT TO THE OR WITH THE STENT PARTIALLY DEPLOYED. THE VASCULAR SURGEON SUCCESSFULLY DEPLOYED THE STENT WITHIN THE PATIENT'S RIGHT SFA.

  Patient problems: Insufficient Information

  MAUDE report 18719586 ↗
• MalfunctionAug 11, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX ENTRUST FOR TREATMENT OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE STENT WAS UNABLE TO DEPLOY. NO PATIENT INJURY WAS REPORTED. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE STENT STRUTS WERE EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510536 ↗
• MalfunctionJul 2, 2023Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX ENTRUST FOR THE TREATMENT OF A 200MM CALCIFIED LESION WITH 80% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A 6FR NON MEDTRONIC SHEATH AND A 035 ANGLED NON MEDTRONIC GUIDEWIRE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO DAMAGE NOTED TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT. THE LOCK PIN WAS REMOVED PRIOR TO DEPLOYMENT. THE LESION WAS PRE-DILATED WITH A 5X60 NON MEDTRONIC DEVICE AND A 5X200 NON MEDTRONIC DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THE STENT  DELIVERY WHEEL BECAME DIFFICULT TO ROLL AFTER STENT WAS PARTIALLY DEPLOYED. PHYSICIAN APPLIED MORE PRESSURE TO THE WHEEL AND THE WIRE BROKE AND PHYSICIAN COULDN¿T DEPLOY THE REMAINING DISTAL END OF THE STENT. THE PHYSICIAN REMOVED THE STRAIN, OPENED THE CLAM SHELL AND DEPLOYED THE REMAINING PORTION OF THE STENT. STENT WAS POST DILATED WITH NON MEDTRONIC 5X100 DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244486 ↗
• MalfunctionOct 18, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO DEPLOY AN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM. A SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE PRE-DILATION AND LASER ATHERECTOMY ALONE DID NOT ALLOW THE STENT TO BE POSITIONED CORRECTLY. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS MET. IT WAS STATED WHEN THE PHYSICIAN BEGAN TO SPIN THE WHEEL TO DEPLOY THE STENT, A WIRE WAS STARTED TO BEGIN TO COME OUT OF THE SEAM IN THE HANDLE NEAR THE THUMBWHEEL. THE STENT DID NOT DEPLOY CORRECTLY AND ELONGATED WHILE THE CATHETER WAS BEING WITHDRAWN FROM THE PATIENT. THE STENT ELONGATED BUT ANOTHER STENT WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624502 ↗
• InjuryJun 15, 2022Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED FIBROUS LESION IN THE RIGHT BRACHIAL ARTERY. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH WERE 6-7MM AND 100MM RESPECTIVELY. THERE WAS NO EMBOLIC PROTECTION 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS LEFT IN PATIENT AND WAS COVERED WITH TWO ONXY CORONARY STENTS (4X38). PARTIAL DEPLOYMENT OCCURRED. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISM OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. THE THUMBSWITCH/LOCK-PIN WERE CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE REMAINING STENT WAS COVERED BY TWO CORONARY STENT TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14698509 ↗
• MalfunctionSep 27, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, CALCIFIED FIBROUS LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER IS 6MM. LESION LENGTH IS 250MM. A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE WAS USED. NO EMBOLIC PROTECTION USED. DEVICE WAS PREPPED WITHOUT ISSUE. LESION WAS PRE-DILATED. IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED. STENT PARTIALLY DEPLOYED. THUMBSCREW WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. LOCK-PIN WAS REMOVED BEFORE DEPLOYMENT ONCE IT WAS IN POSITION. THEY WERE ABLE TO DEPLOY REST OF STENT MANUALLY BY PULLING BACK ON SHEATH. STENT ENDED UP BEING IN CORRECT PLACE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532091 ↗
• MalfunctionSep 20, 2021Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PHYSICIAN USED AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 55CM 6FR NON-MEDTRONIC SHEATH AND A 0.014 300CM NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A FIBROUS LESION IN THE PATIENT¿S LEFT MID PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). LITTLE VESSEL CALCIFICATION AND NO VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% 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. THE THUMBSCREW/LOCK-PIN CHECKED WAS FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK PIN WAS REMOVED JUST BEFORE DEPLOYMENT. PRE-DILATION WAS PERFORMED USING A 5X200 PACIFIC XTREME PTA BALLOON CATHETER. THE STENT WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT THE STENT WOULD ONLY PARTIALLY DEPLOY WITHIN THE SFA. THE THUMB WHEEL WOULD JUST SPIN AND CLICK, BUT NOT PULL BACK ON THE OUTER SHEATH ANYMORE SO WOULD NOT DEPLOY THE REST OF THE STENT. WHEN THE DEPLOYMENT HANDLE WAS BROKEN OPEN THE THUMBWHEEL STRING APPEARED TO HAVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495329 ↗
• MalfunctionJun 16, 2021Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S DISTAL S UPERFICIAL FEMORAL ARTERY (SFA). 80-90% LESION STENOSIS 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. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. BRACHIAL ACCESS WAS USED. THE LESION WAS NOT PRE-DILATED, IT WAS REPORTED TO BE ONLY ATHERECTOMY WITH A NON-MEDTRONIC DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE SFA WAS TREATED WITH A NON-MEDTRONIC ORBITAL ATHERECTOMY DEVICE FOLLOWED BY ATTEMPTED USE OF THE EVERFLEX ENTRUST. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. NO EXCESSIVE FORCE WAS USED. DEPLOYMENT ISSUES ARE REPORTED. NO DAMAGE WAS NOTED TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. IT IS REPORTED THE THUMBWHEEL JAMMED AT HALFWAY POINT DURING DEPLOYMENT. PRESSURE WAS APPLIED AND THE THUMBWHEEL BROKE. THE WHOLE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED AND TO SEE IF POSSIBLY IT COULD

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007096 ↗
• MalfunctionApr 30, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE EVERFLEX SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035% GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE VESSEL IS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM 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. THE DEVICE WAS NO PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT AFTER THE DEVICE WAS PREPPED AND LOADED ON THE WIRE, IT WAS ADVANCED TO THE TARGET LESION. THE RED SECURITY TAB WAS REMOVED AND THE PHYSICIAN STARTED DEPLOYING THE STENT USING THE THUMB WHEEL. AFTER HALF OF THE STENT WAS DEPLOYED THE THUMB WHEEL WOULD NO LONGER MOVE. THE PHYSICIAN TRIED AGAIN AND THE THUMB WHEEL STARTED TO MOVE AND THE STENT CONTINUED TO DEPLOY WITH NO I SSUES. WITH 95% OF THE STENT DEPLOYED THE THUMB WHEEL FROZE AGAIN AND WOULD NOT MOVE. THE PHYSICIAN THEN DECIDED TO PULL THE CATHETER BACK AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751949 ↗
• MalfunctionDec 23, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING PATIENT TREATMENT. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT ATTEMPT. DEPLOYMENT ISSUES ARE NOTED. IT IS REPORTED THE STENT PARTIALLY DEPLOYED. THE PHYSICIAN PULLED SHEATH BACK AND REMAINDER OF STENT DEPLOYED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11065095 ↗
• MalfunctionAug 24, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT SYSTEM DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS TOTAL OCCLUSION. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. THERE WAS NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. SEVERE RESISTANCE WAS ENCOUNTERED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. THE LOCK-PIN WAS REMOVED. IT IS REPORTED THE STENT COULD NOT BE DEPLOYED. THE STENT WAS EVENTUALLY DEPLOYED. THE WHEEL DID NOT SEEM TO BE WORKING CORRECTLY, IT WOULD STALL AND THEN CLICK AS THE PHYSICIAN TURNED THE DEPLOYMENT WHEEL. THE STENT ELONGATED AS IT WAS DEPLOYED AND AN ADDITIONAL STENT WAS USED TO COVER THE LESION AND OVERLAP WITH THE ORIGINAL STENT THAT ELONGATED TO COMPLETE THE PROCEDURE. THE DELIVERY CATHETER WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10441097 ↗
• InjurySep 16, 2019Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO IMPLANT AN EVERFLEX ENTRUST SELF EXPANDING STENT WITH A 7FR SHEATH TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT PROXIMAL COMMON ILIAC TO SFA WITH A CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH WAS 5MMAND 120MM RESPECTIVELY. THE VESSEL WAS SEVERELY TORTUOUS. THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THERE WAS DEPLOYMENT ISSUE, WITH THE STENT PARTIALLY DEPLOYED.. RESISTANCE WAS ENCOUNTERED DURING DELIVERY TO LESION WITH FORCE APPLIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LESION WAS PRE DILATED USING A 5.0 BALLOON. IT WAS REPORTED THAT STENT WAS ADVANCED PARTIALLY THROUGH A DISTAL SFA AND POPLITEAL LESION. STENT PARTIALLY DEPLOYED APPROXIMATELY 20MM OF THE STENT. THE STENT WAS DR AGGED THROUGH THE SHEATH AND RETRIEVED. AFTER STENT RETRIEVAL, IT WAS DISCOVERED THAT PART OF THE STENT (THE PART THAT HAD BEEN DEPLOYED), HAD SEPA

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9070537 ↗
• MalfunctionAug 20, 2019Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN USED AN EVERFLEX ENTRUST WITH A 6FR SHEATH AND 0.0335 GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. NO TORTUOSITY REPORTED AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 75-80% STENOSIS. IFU WAS FOLLOWED. EMBOLIC PROTECTION WAS NOT USED. DEVICE PREPPED WITHOUT ISSUE. PRE-DILATION PERFORMED USING A 5X120 PACIFIC BALLOON. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. IT IS REPORTED DURING DEPLOYMENT, WHEN THE STENT WAS PARTIALLY DEPLOYED, THE STENT THUMBWHEEL JAMMED AND STOPPED SPINNING. THE PHYSICIAN WAS SUCCESSFUL IN GETTING THE WHEEL UNJAMMED, BUT THE STENT WOULD NOT UNSHEATHE. THE STENT WAS DEPLOYED UNDERNEATH THE CATHETER SHEATH BUT WHEN THE CATHETER SHEATH WAS REMOVED, THE STENT WAS COMPLETELY ELONGATED. AFTER TIME, A BALLOON WAS ABLE TO BE USED FOR POST-DILATION. PROCEDURE COMPLETED SUCCESSFULLY. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8909660 ↗
• MalfunctionJul 15, 2019Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  PHYSICIAN USED AN EVERFLEX ENTRUST WITH A 5/6FR RADIAL SHEATH AND 0.035 GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION WITHIN THE PATIENT¿S ID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED. DIFFICULTY WAS EXPERIENCED WHEN TRYING TO CROSS. IT IS REPORTED STENT DEFORMATION DURING POSITIONING OCCURRED. THE STENT IS REPORTED TO HAVE PARTIALLY DEPLOYED AND AN AUDIBLE CLICK WAS HEARD. THE STENT THEN STOPPED DEPLOYING EVEN WHILE CRANKING THE THUMB ROLLER. THE RED SAFETY DEVICE WAS ATTEMPTED TO BE REMOVED AND REINSERTED. EVENTUALLY THE DELIVERY DEVICE WAS PULLED BACK AND THE STENT SNAPPED. EXCESSIVE FORCE WAS USED. DEVICE WAS REMOVED LEAVING THE DEPLOYED PORTION IN THE PATIENT. PROLONGED BALLOON INFLATION WAS PERFORMED TO COMPLETE THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 8788703 ↗
• MalfunctionApr 10, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE ARTERY WAS 5MM IN DIAMETER. NO EMBOLIC PROTECTION WAS USED. THE IFU WAS FOLLOWED DURING PREPARATION WITH NO ISSUES. IT WAS REPORTED THAT STENT FORESHORTENING WAS NOTED AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER EVERFLEX ENTRUST (6.0 X 120MM) WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8498908 ↗
• MalfunctionFeb 11, 2019Failure to Fire; Failure to Fire

  THE PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST TO TREAT A CALCIFIED PLAQUE CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE TORTUOSITY WAS REPORTED. A 6FR NON MEDTRONIC SHEATH AND A 0.014 X NON MEDTRONIC GUIDEWIRE WAS USED. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING OR THE DEVICE WHEN REMOVING FROM THE HOOP/TRAY. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISM OR HANDLE PRIOR TO DEPLOYMENT. THE THUMBSCREW/LOCK PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE AND THE LOCK PIN REMOVED WHEN THE PHYSICIAN WAS READY TO DEPLOY THE STENT. THE LESION WAS PREDILATED WITH A 4 X 150 DEVICE. THE ENTRUST DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE STENT WAS DEPLOYED ABOUT HALF WAY WHEN THE THUMB SWITCH STARTED TO TURN WITHOUT ANY FURTHER DEPLOYMENT. THE HANDLE WAS BROKEN OPEN AND THE STENT DEPLOYED MANUALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8324860 ↗
• MalfunctionDec 4, 2018Mechanical Problem; Mechanical Problem

  PHYSICIAN USED AN EVERFLEX ENTRUST WITH A 7F 45CM NON-MEDTRONIC SHEATH DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO PACKAGING OR ISSUE NOTED WHEN REMOVING DEVICE FROM PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. THE THUMBSCREW/LOCK-PIN CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE LOCK-PIN WAS REMOVED WHEN PHYSICIAN WAS READY TO DEPLOY THE STENT. THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, BUT DEPLOYMENT ISSUES WERE EXPERIENCED. THE PHYSICIAN HAD TO UNDO THE HANDLE OF THE STENT DELIVERY SYSTEM AND PULL THE SHEATH IN ORDER TO FULLY DEPLOY THE STENT. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET ARES. NO FURTHER TREATMENT WAS REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8127971 ↗
• MalfunctionAug 14, 2018Material Deformation; Material Deformation

  THE PHYSICIAN ATTEMPTED TO USE A EVERFLEX ENTRUST WITH A 6MM TERUMO AS PER THE IFU TO TREAT A 100MM MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS PRE-DILATED. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENTS ANATOMY. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THERE WAS DEPLOYMENT ISSUES. THE GUIDEWIRES WERE STUCK IN THE STENT DEPLOYMENT PORTION. THE STENT ELONGATED WHEN THE WIRE AND SYSTEM WAS REMOVED. THE LOCK PIN WAS REMOVED PRIOR TO DEPLOYMENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE NOR WAS EXCESSIVE FORCE USED. THE PROCEDURE WAS COMPLETED BY LEAVING THE ELONGATED STENT IN THE SFA. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7781893 ↗
• MalfunctionJun 26, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A 6 X 150 EVERFLEX ENTRUST DEVICE TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LEFT DISTAL SFA 120MM LESION EXHIBITING (B)(4)% STENOSIS. ACCESS WAS THROUGH THE LEFT BRACHIAL ARTERY. THE VESSEL DIAMETER WAS REPORTED TO BE 6MM IN DIAMETER. A NON-MEDTRONIC 6F SHEATH AND A NON-MDT 018 GUIDEWIRE WERE USED. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED DURING PREP. THE LESION WAS PREDILATED WITH A 4MM DEVICE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED AAA ENDOGRAFT STENT WHICH HAD A PRONOUNCED ANGLE IN THE AORTA AT THE LEVEL OF THE RENAL ARTERIES. IT WAS REPORTED THAT THE DEVICE WOULD NOT DEPLOY AND THE DEVICE WAS WITHDRAWN. THE LESION AREA WAS THEN REDILATED WITH A 6MM BALLOON. THE PHYSICIAN THEN OPENED A NEW 7 X 150 EVERLFEX ENTRUST DEVICE. THE PHYSICIAN ENCOUNTERED DIFFICULTY BUT DID SUCCEED IN DEPLOYING THE SECOND STENT. NO PATIENT INJURY WAS REPORTED. AFTER STENT DEPLOYMENT, THE LESION WAS POST DILATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7636987 ↗
• InjuryOct 20, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX SELF-EXPANDING STENT WITH AN ENTRUST DELIVERY SYSTEM TO TREAT A CTO (CHRONIC TOTAL OCCLUSION) IN THE MID SFA. THE LESION WAS 150MM AND SEVERELY CALCIFIED. THE DIAMETER OF THE VESSEL WAS 6MM AND THE VESSEL WAS DESCRIBED AS MODERATELY TORTUOUS. IT WAS REPORTED THAT THE ILIAC ARTERIES OF THE PATIENT COULD NOT BE CROSSED FROM THE CONTRALATERAL SIDE AND THE PHYSICIAN ACCESSED THE SFA FROM THE ARM. THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED AS PER THE IFU WITH NO ISSUES NOTED. THE LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. THE LESION WAS PRE-DILATED USING A NON-MEDTRONIC DEVICE. A 6 FR, 90 CM NON-MEDTRONIC SHEATH AND A 0.035" 260CM NON MEDTRONIC GUIDEWIRE WERE USED IN THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE DURING THE DELIVERY OF THE EVERFLEX ENTRUST STENT AND EXCESSIVE FORCE WAS USED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. THE ROTATING WHEEL OF THE DEPLOYMENT HANDLE OF THE CATHETER CRACKED DURING DEPLOYMENT AND THE STENT WOULD NOT DEPLOY. THE LOCK PIN WAS NOT REMOVED. THE UN-DEPLOYED STENT WAS REMOVED. THE PHYSICIAN ACCESSED THE DORSALIS PEDIS WITH A NEW 5FR SHEAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6964786 ↗
• MalfunctionSep 21, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  PHYSICIAN EMPLOYED THE USE OF AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 6 FR NON-MEDTRONIC SHEATH AND .014 NON-MEDTRONIC GUIDEWIRE FOR THE TREATMENT OF A SEVERELY CALCIFIED 300MM LESION IN DISTAL LOCATION IN THE MID RIGHT SFA. LESION EXHIBITED CHRONIC TOTAL OCCLUSION (CTO). EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS CARRIED OUT USING A 4MM/200MM PTA BALLOON. THE THUMBSCREW/LOCK-PIN CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT WAS REPORTED THAT THERE WERE DEPLOYMENT ISSUES EXPERIENCED. THE THUMB ROLL ON HANDLE STOPPED/WOULD NOT CONTINUE TO DEPLOY STENT. THE PHYSICIAN HAD TO BREAK OFF HANDLE FROM SHAFT AND MANUALLY PULL BACK OUTER SHEATH FROM INNER SHEATH TO COMPLETE DEPLOYMENT OF STENT. FURTHER STENTING WAS REQUIRED MORE PROXIMALLY DUE TO LESION BEING LONGER THAN THE STENT (WAS GOING TO NEED MULTIPLE STENTS ANYWAY). THE PROCEDURE COMPLETED WITHOUT ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881779 ↗

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