EverFlex Protégé EverFlexRecalls & reported problems across all models

We found 27 models of EverFlex Protégé EverFlex by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 94 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2018 and Apr 7, 2026 — classified as 1 death, 49 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EverFlex Protégé EverFlex problems

EverFlex Protégé EverFlex models

27 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EverFlex™ Protégé™ EverFlex™ PRB35-06-150-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 death21 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-06-200-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  20 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-06-120-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  6 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-06-060-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-06-080-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-060-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-080-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-150-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-200-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-08-060-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-06-020-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-06-040-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-06-040-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-06-100-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-040-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-060-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-080-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-120-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ Protégé™ EverFlex™ PRB35-07-020-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ Protégé™ EverFlex™ PRB35-07-030-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ Protégé™ EverFlex™ PRB35-08-030-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ Protégé™ EverFlex™ PRB35-08-040-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ Protégé™ EverFlex™ PRB35-08-080-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ Protégé™ EverFlex™ PRB35-08-080-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ Protégé™ EverFlex™ PRB35-08-100-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ Protégé™ EverFlex™ PRB35-08-120-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ Protégé™ EverFlex™ PRB35-08-150-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report

Recent EverFlex Protégé EverFlex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Premature Activation

  IT WAS REPORTED THAT, DURING AN ATTEMPTED PERIPHERAL ARTERY STENTING PROCEDURE INVOLVING A CALCIFIED TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (MID SEGMENT), A PROTEGE EVERFLEX STENT HAD A DEPLOYMENT ISSUE DESCRIBED AS PRE-DEPLOYMENT WHILE ON THE WAY TO THE TARGET SITE IN THE PATIENT. THE TARGET LESION WAS DESCRIBED AS SEVERELY CALCIFIED WITH 80% STENOSIS, A LESION LENGTH OF 40 MM, MINIMAL TORTUOSITY, AND AN ARTERY DIAMETER OF 6.5 MM. A 6F TERUMO DESTINATION SHEATH AND A TERUMO RUN THROUGH GUIDEWIRE WERE USED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE VESSEL WAS NOT PRE-DILATED OR POST-DILATED. THE STENT DID NOT REMAIN IN THE PATIENT AND WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION, AND NO VESSEL DAMAGE WAS REPORTED. THE PROCEDURE WAS COMPLETED USING A NEW PROTEGE EVERFLEX 7×60 DEVICE, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY AND NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798425 ↗
• MalfunctionMar 25, 2026Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX FOR TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. A 6FR NON MEDTRONIC SHEATH AND 0.014" NON MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS PRE-DILATED WITH A 5X40 NANOCROSS. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED (AT TARGET SITE) WITHIN THE PATIENT VASCULATURE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT. THE DEVICE WAS SUCCESSFULLY IN TANDEM WITH DELIVERY SYSTEM WITHOUT INJURY/INTERVENTION. ANOTHER EVERFLEX WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY OR INTERVENTION WAS ASSOCIATED WITH THIS EVENT. AN EVERCROSS WAS USED FOR POST-DILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685429 ↗
• InjuryMar 11, 2026Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF PLAQUE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (PROXIMAL AND MID SEGMENTS, LESION LENGTH GREATER THAN 190MM, ARTERY DIAMETER 6MM) WITH THE PROTEGE EF V10, STENT DEFORMATION WAS OBSERVED IN THE LATE STAGES OF DEPLOYMENT. THE STENT/STRUTS WERE DEFORMED IN VIVO, AND THE STENT ACCORDIONED. A KINK WAS NOTED IN THE PROXIMAL STENT DURING THE PROCEDURE. THE STENT WAS SURGICALLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573974 ↗
• InjuryMar 5, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE EP SPD2-US-050-320 SPIDER FX DEVICE, A PATIENT EXPERIENCED A 30-MINUTE DELAY IN SURGERY DUE TO A PRODUCT MALFUNCTION. THE PROCEDURE TARGETED A 100% STENOSED LESION WITH PLAQUE LOCATED IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, WITH A LESION LENGTH OF 200MM AND ARTERY DIAMETER OF 7MM. MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. A 7X40 NON-MEDTRONIC SHEATH WAS USED. THE VESSEL WAS POST-DILATED WITH A 6X80 EVERCROSS PTA BALLOON. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN RETRIEVING THE DEVICE. THE DISTAL PART OF SPIDER DETACHED AND REMAINS OF THE PRODUCT WERE LEFT ON THE STENT. THE DEPLOYED STENT WAS ALTERED AND CORRECTED BY STENT OVERLAP AND PTA. THE DEPLOYED STENT WAS AN 8X60 PROTEGE EVERFLEX STENT. THE RESIDUAL MATERIAL/ENDO-TRASH WAS STENTED OVER AND THE PROCEDURE WAS COMPLETED. NO VESSEL DAMAGE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517647 ↗
• 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 ↗
• InjuryFeb 16, 2026Fracture

  IT WAS REPORTED THAT THE STENT PRB35-08-060-120 PROTEGE EF V10 FRACTURED DURING A PROCEDURE. THE PHYSICIAN SNARED OUT THE FRACTURED STENT AND USED ANOTHER STENT ON THAT AREA THAT NEEDED STENTED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24349371 ↗
• MalfunctionFeb 16, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY USING THE STENT PR B35-08-150-120 PROTEGE EF V10 AND STENT PRB35-07-150-120 PROTEGE EF V10, THERE WERE DEPLOYMENT ISSUES. THE FIRST STENT COULD NOT BE DEPLOYED, AND THE HANDLE BROKE DURING THE ATTEMPTED DEPLOYMENT. WHEN A SECOND STENT WAS USED, THERE WAS DIFFICULTY DEPLOYING IT AS WELL. BOTH DEVICES WERE SAFELY REMOVED WITHOUT EXPOSING ANY STENT STRUTS OR REQUIRING INTERVENTION FOR REMOVAL. THE VESSEL WAS PRE-DILATED WITH A 4/80 NANO DEVICE AND POST-DILATED WITH A 6/120 PACIFIC PLUS DEVICE. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, INFECTIONS, DEATHS, OR IRREGULARITIES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342945 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTÉGÉ EVERFLEX WAS USED TO TREAT THE LEFT SUPERFICIAL FEMORAL DISTAL, POPLITEAL 1 SEGMENT. APPROXIMATELY 25 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT SUPERFICIAL FEMORAL ARTERY IN-STENT RE-STENOSIS. DUPLEX US SHOWED LEFT IN-STENT STENOSIS. PATIENT UNDERWENT LEFT ANGIOGRAM WITH LEFT FEMOROPOPLITEAL ATHERECTOMY AND BALLOON ANGIOPLASTY. PATIENT TOLERATED PROCEDURE WELL AND PULSE VOLUME RECORDINGS DEMONSTRATED NORMAL FLOW BILATERALLY. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 24317890 ↗
• 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 ↗
• MalfunctionJan 29, 2026Premature Activation; Difficult to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

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

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815340 ↗
• MalfunctionDec 11, 2025Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778207 ↗
• MalfunctionNov 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A STENT PRB35-07-060-120 PROTEGE EF V10 WAS USED DURING TREATMENT OF A SOFT TISSUE LESION WITH DISSECTION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (PROXIMAL LOCATION). THE LESION MEASURED 50MM IN LENGTH WITH AN ARTERY DIAMETER OF 6MM AND WAS C HARACTERIZED BY MINIMAL TORTUOSITY AND MINIMAL CALCIFICATION. A 6FR 45CM TERUMO DESTINATION WAS USED. A TERUMO 260CM ADVANTAGE WAS USED. VESSEL WAS PRE-DILATED WITH 6 X 200 EVERCROSS. VESSEL WAS POST-DILATED. MEASURED LESION WITH 7X60 BALLOON, DOCTOR REQUESTED 7 X 60 STENT, 7 X60X 120 EVERFLEX STENT WAS VERIFIED WITH SCRUB TECH AND GIVEN TO SCRUB TECH. STENT WAS PREPPED PER IFU AND ADVANCED TO LESION SITE TO EXTEND PREVIOUSLY DEPLOYED STENT AND DEPLOYED. PHYSICIAN NOTED THAT DEVICE DIDN'T LOOK LIKE A 60MM STENT. PUT IN THE 7 X 60 BALLOON TO COMPARE LENGTH OF BALLOON TO STENT LENGTH. UPON COMPARISON OF THE BALLOON WITH THE STENT THE PHYSICIAN SAID THE STENT CANNOT BE 60MM. STENT DEPLOYED WITHOUT ANY ISSUES. PHYSICIAN WOULD HAVE PREFERRED THE 60MM STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665651 ↗
• MalfunctionNov 7, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SOFT TISSUE, MODERATE TORTUOSITY, 100 MM LENGTH, 6 MM DIAMETER), A DEPLOYMENT ISSUE OCCURRED WITH THE PROTEGE EF, STENT PRE-DEPLOYED ON THE WAY TO THE TARGET SITE IN THE PATIENT. THE STENT WAS NEVER IMPLANTED AND WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, OR VESSEL DAMAGE WERE REPORTED. THE VESSEL WAS PRE-DILATED USING AN EVERCROSS DEVICE, AND THE SHEATH AND GUIDEWIRE DETAILS WERE PROVIDED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND NO RESISTANCE OR PACKAGING DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED USING A NEW PROTEGE EVERFLEX DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497090 ↗
• 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 ↗

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