EMBOSHIELD NAV6 22437-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 08717648137747), received between Jan 9, 2017 and Sep 30, 2026 — classified as 27 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Material Separation” (39 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50949636 ↗
• InjuryJun 30, 2026Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE LESION AND SIGNIFICANT RESISTANCE WAS NOTED AND THE FILTER PREMATURELY DEPLOYED. THE FILTER WAS RETRIEVED WITH A NON-ABBOTT GUIDING CATHETER AND NOT USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668274 ↗
• MalfunctionMay 4, 2026Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS LESION IN THE INTERNAL CAROTID ARTERY. THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE TORTUOSITY OF THE COMMON CAROTID ARTERY. DURING REMOVAL OF THE FILTER WITH THE RETRIEVAL CATHETER, THE FILTER BECAME STUCK IN THE SHEATH. THE TIP OF THE RETRIEVAL CATHETER BROKE IN TWO AND SEPARATED FROM THE CATHETER. THE BARE WIRE WAS STILL IN PLACE; THEREFORE THE FILTER AND RETRIEVAL CATHETER WERE REMOVED WITHOUT INCIDENCE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069791 ↗
• MalfunctionFeb 10, 2026Difficult to Insert; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT WHEN ATTEMPTING TO LOAD THE FILTRATION ELEMENT INTO THE DELIVERY CATHETER (DC) POD WITH A TORQUE DEVICE DURING PREPARATION OF A SMALL EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS), THE TIP OF THE DC WAS BENT; HOWEVER, THE FILTRATION ELEMENT LOADED INTO THE DC POD WITH DIFFICULTY. THE BAREWIRE TIP WAS OBSERVED TO BE SEPARATED. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT IS NOTED THAT BLOOD AND CONTRAST ON THE FILTER ELEMENT AND HANDLE WERE LIKELY LEFT DURING PREPARATION. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308450 ↗
• InjuryJan 29, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN INTERNAL CAROTID ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS USED. DURING REMOVAL OF THE EPS, RESISTANCE WAS NOTED WITH THE ANATOMY. FORCE WAS APPLIED AND THE DISTAL END OF THE BAREWIRE SEPARATED. A SNARE WAS USED TO REMOVE THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210703 ↗
• MalfunctionJan 27, 2026Break; Stretched; Failure to Advance

  RETURNED DEVICE ANALYSIS IDENTIFIED THE TIP WAS SEPARATED AND NOT RETURNED. THE ACCOUNT WAS NOT AWARE OF THE SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192939 ↗
• InjuryJan 5, 2026Material Separation; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORTS, IT WAS STATED THAT THE DETACHED TIP SEGMENT OF THE GUIDE WIRE WAS NOT REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23959875 ↗
• MalfunctionDec 1, 2025Break; Difficult to Insert; Deformation Due to Compressive Stress; Material Twisted/Bent; Break; Difficult to Insert; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE FILTER OF THE SMALL EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS BEING LOADED INTO THE DELIVERY CATHETER (DC) POD, THE TIP OF THE DC WAS NOTED TO BE BENT AND FRACTURED. BUNCHING WAS NOTED ON THE DC POD. THEREFORE, THE FILTER WAS NOT ABLE TO BE LOADED INTO THE DC POD AND THE DEVICE WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682519 ↗
• InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT INTERNAL CAROTID ARTERY WITH 90% STENOSIS. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS DEPLOYED NORMALLY IN THE CAROTID ARTERY BUT COULD NOT BE RETRIEVED AT THE END OF THE PROCEDURE AS WHEN THE INTACT BAREWIRE WAS REMOVED, THE FILTER REMAINED INSIDE THE PATIENT. AN ADDITIONAL STENT WAS IMPLANTED TO EMBED THE FILTER INTO THE VESSEL. THE PATIENT WAS HOSPITALIZED ADDITIONAL TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23512026 ↗
• InjurySep 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE INTERNAL CAROTID. AFTER A 190CM EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS DEPLOYED AT THE INTENDED LOCATION, THE TIP OF THE BAREWIRE WAS NOTED TO HAVE SEPARATED. THEREFORE, THE SEPARATED PORTION WAS SNARED FROM THE ANATOMY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137198 ↗
• MalfunctionAug 25, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 190CM EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS), THAT THE TIP OF THE BAREWIRE WAS NOTED TO BE BROKEN. THEREFORE A NEW EMBOSHIELD NAV 6 WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885621 ↗
• MalfunctionJul 22, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN AN UNKNOWN ARTERY. DURING PREPARATION OF THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS), THE FILTRATION ELEMENT WAS NOT COMPLETED PULLED INTO THE DELIVERY CATHETER (DC) POD. THE NAV6 EPS WAS NOT USED AND A NEW ONE WAS PREPARED. THE NAV6 EPS WAS ADVANCED INTO THE PATIENT ANATOMY AND DEPLOYED. DURING REMOVAL THE FILTER WAS NOT COMPLETELY RETRACTED INTO THE RETRIEVAL CATHETER THEREFORE THE FILTER CAME OUT OF THE RETRIEVAL CATHETER WHILE IN THE SHEATH. THE BAREWIRE WAS THEN REMOVED WHICH MADE THE STEP ON THE BAREWIRE PULL THE FILTER INTO THE RETRIEVAL CATHETER AND THE FILTER WAS REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563868 ↗
• MalfunctionJun 25, 2025Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED DE NOVO LESION IN THE INTERNAL CAROTID ARTERY. THE BAREWIRE OF THE SMALL EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED WITH DIFFICULTY DUE TO RESISTANCE WITH THE GUIDE CATHETER. THEN THE EPS WAS REMOVED FROM THE PATIENT AND THE BAREWIRE WAS NOTED TO BECOME UNRAVELED [BREAK AND STRETCHED]. THEREFORE, ANOTHER EMBOSHIELD EPS DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331181 ↗
• MalfunctionJun 5, 2025Activation Failure; Material Split, Cut or Torn; Activation Failure; Material Split, Cut or Torn

  THIS WILL BE FILED. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE INTERNAL CAROTID ARTERY. A 190CM EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, COMPLETELY FAILED TO DEPLOY, AND SUBSEQUENTLY FOLLOWING THE EPS REMOVAL THE DELIVERY CATHETER POD WAS NOTED TO HAVE RUPTURED [TORN]. THEREFORE, ANOTHER EMBOSHIELD NAV 6 WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153442 ↗
• MalfunctionJun 4, 2025Difficult to Flush; Contamination /Decontamination Problem; Difficult to Flush; Contamination /Decontamination Problem

  NMPA REPORT NUMBER IS (B)(4). IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CAROTID ARTERY WITH 90% STENOSIS. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS USED IN THE TARGET LESION. THE RETRIEVAL CATHETER WAS BEING FLUSHED WHEN SIGNIFICANT RESISTANCE WAS NOTED AND NO LIQUID FLOWING OUT OF THE QUICK EXCHANGE PORT. THE TIP OF THE RETRIEVAL CATHETER WAS OBSERVED TO HAVE A WHITE UNIDENTIFIED SUBSTANCE INSIDE. ANOTHER RETRIEVAL CATHETER FROM A NEW EMBOSHIELD NAV 6 EPS WAS USED TO RETRIEVE THE FILTER AND COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142499 ↗
• MalfunctionMar 13, 2025Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Deformation Due to Compressive Stress; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INTERNAL CAROTID ARTERY, DE NOVO, WITH MILD CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE LESION AND THE FILTER WAS DEPLOYED. REPORTEDLY DUE TO THE TORTUOUS ANATOMY, THE 6FR GUIDING CATHETER HAD INSUFFICIENT SUPPORT AND THE DELIVERY CATHETER AND FILTER OF THE EMBOSHIELD NAV6 FELL OFF [DISLODGED] FROM THE REST OF THE DEVICE BUT DID NOT SEPARATE OR BREAK. THE EMBOSHIELD NAV6 EPS FILTER AND DELIVERY CATHETER WERE REMOVED IMMEDIATELY WITH THE 6FR GUIDING CATHETER. AFTER REMOVAL FROM THE ANATOMY, IT WAS ATTEMPTED TO PULL THE FILTER INTO THE DELIVERY CATHETER AND IT WAS NOTED THE DELIVERY CATHETER TIP WAS BENT. AN 8FR GUIDING CATHETER WAS ADVANCED AND A NEW EMBOSHIELD NAV6 EPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596602 ↗
• MalfunctionJan 3, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE RIGHT INTERNAL CAROTID ARTERY. DURING PREPARATION OF THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS) THE FILTRATION ELEMENT COULD NOT BE LOADED INTO THE DELIVERY CATHETER POD. THE EPS WAS REMOVED AND REPLACED WITH ANOTHER NAV6 TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE FILTRATION ELEMENT WAS SEPARATED AT THE DISTAL NECK AREA LOCATED AT THE POINT WHERE PROXIMAL EDGE OF GOLD MARKER IS BONDED TO DISTAL NECK MATERIAL. THE GOLD MARKER AND DISTAL PORTION OF DISTAL NECK WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066210 ↗
• MalfunctionDec 3, 2024Break; Difficult to Insert; Deformation Due to Compressive Stress; Break; Difficult to Insert; Deformation Due to Compressive Stress

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF AN EMBOSHIELD NAV 6 THAT THE FILTER COULD NOT BE LOADED INTO THE DELIVERY CATHETER BECAUSE THE DELIVERY CATHETER WAS NOTED TO BE BROKEN. ANOTHER EMBOSHIELD WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS PROVIDED. THE TIP OF THE DELIVERY CATHETER WAS NOTED TO BE BENT DURING ATTEMPTS TO LOAD THE EMBOSHIELD NAV 6 FILTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830670 ↗
• InjuryNov 9, 2024Entrapment of Device; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Entrapment of Device; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20647843 ↗
• MalfunctionNov 6, 2024Difficult to Insert; Material Twisted/Bent; Material Split, Cut or Torn; Difficult to Insert; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED DURING THE PREPARATION OF A EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM, WHEN PULLING BACK TO LOAD THE FILTRATION ELEMENT INTO THE DELIVERY CATHETER (DC), THE DC BUCKLED ON ITSELF AT THE GUIDE WIRE EXIT NOTCH AND THE FILTRATION ELEMENT COULD NOT BE LOADED. THE DEVICE WAS REPLACED WITH A NEW EMBOSHIELD, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED AND THE ANALYSIS NOTED THE REPORTED KINKED/ BENDS, BUT ALSO NOTED A TEAR IN THE JACKET ALONG THE DELIVERY CATHETER. THE TEARS AND KINKED WERE CONFIRMED BY THE ACCOUNT TO OCCUR DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619799 ↗
• InjuryOct 8, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY. THE FIRST EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE LESION AND DEPLOYED. DURING THE PROCEDURE THE TECH ACCIDENTALLY PULLED ON THE BAREWIRE, MOVING THE FILTER DOWN THE CAROTID ARTERY. THE FILTER WAS RECAPTURED AND REMOVED AND A NEW EMBOSHIELD NAV6 EPS FILTER WAS DEPLOYED. AT THE END OF THE PROCEDURE IT WAS FOUND THAT THE RETRIEVAL CATHETER HAD BEEN DISCARDED SO A NON-ABBOTT CATHETER WAS USED TO CAPTURE THE FILTER AND REMOVE IT FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402461 ↗
• MalfunctionMay 7, 2024Device Difficult to Setup or Prepare; Material Separation; Stretched; Device Difficult to Setup or Prepare; Material Separation; Stretched

  IT WAS REPORTED THAT DURING PREPARATION OF THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS), DURING SHAPING, THE COILS OF THE BAREWIRE WERE NOTED TO BE STRETCHED. THE CORE AND COILS WERE INTACT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER EMBOSHIELD NAV6 EPS WAS PREPARED AND WHEN THE BAREWIRE WAS BEING SHAPED, IT WAS FOUND THAT THE COILS OF THE BAREWIRE WERE NOTED TO BE STRETCHED. THE CORE AND COILS WERE INTACT. ADDITIONALLY, THE DELIVERY CATHETER OF THE SECOND EMBOSHIELD NAV6 WAS SEPARATED DURING THE PROCESS OF PACKING THE DEVICE FOR RETURN. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A THIRD EMBOSHIELD NAV6 EPS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT BOTH DEVICES HAD SEPARATED TIP COILS AND THE CORE WAS SEPARATED AND A PORTION WAS NOT RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262968 ↗
• MalfunctionMay 7, 2024Device Difficult to Setup or Prepare; Material Separation; Stretched; Device Difficult to Setup or Prepare; Material Separation; Stretched

  IT WAS REPORTED THAT DURING PREPARATION OF THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS), DURING SHAPING, THE COILS OF THE BAREWIRE WERE NOTED TO BE STRETCHED. THE CORE AND COILS WERE INTACT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER EMBOSHIELD NAV6 EPS WAS PREPARED AND WHEN THE BAREWIRE WAS BEING SHAPED, IT WAS FOUND THAT THE COILS OF THE BAREWIRE WERE NOTED TO BE STRETCHED. THE CORE AND COILS WERE INTACT. ADDITIONALLY, THE DELIVERY CATHETER OF THE SECOND EMBOSHIELD NAV6 WAS SEPARATED DURING THE PROCESS OF PACKING THE DEVICE FOR RETURN. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A THIRD EMBOSHIELD NAV6 EPS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.RETURNED DEVICE ANALYSIS IDENTIFIED THAT BOTH DEVICES HAD SEPARATED TIP COILS AND THE CORE WAS SEPARATED AND A PORTION WAS NOT RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262819 ↗
• MalfunctionMay 1, 2024Break; Stretched; Material Too Soft/Flexible; Break; Stretched; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE CAROTID ARTERY. THE SMALL EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO IT'S INTENDED LOCATION; HOWEVER, THE PHYSICIAN NOTED THAT THE EPS DID NOT FEEL AS EXPECTED DURING ADVANCEMENT. THEREFORE, THE EPS WAS REMOVED FROM THE PATIENT AND THE TIP OF THE BAREWIRE WAS NOTED TO HAVE BECOME UNRAVELED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER EMBOSHIELD NAV 6 EPS WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222938 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INTERNAL CAROTID ARTERY THAT IS 95-99% STENOSED. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED AND DEPLOYED SUCCESSFULLY. ANGIOPLASTY WAS PERFORMED AND BLOOD FLOW WAS NOTED TO BE GOOD. AN UNSPECIFIED STENT WAS DEPLOYED, FOLLOWED BY A SECOND ANGIOPLASTY; HOWEVER, THE BLOOD WOULD FLOW UP THE COMMON CAROTID, BUT ONCE IT REACHED THE STENT IT WOULD STOP. ONCE THE FILTER WAS RETRIEVED BLOOD FLOW WAS RESTORED THROUGH THE STENT AND INTO THE BRAIN. IT IS BELIEVED THAT THE DEPLOYED FILTER WAS CAUSING AN OCCLUSION WITHIN THE STENT. THE PATIENT WAS NOTED TO EXPERIENCE SMALL STROKES FOLLOWING THE PROCEDURE AND WAS PROVIDED MEDICATION. THE PATIENT STAYED SEVERAL EXTRA DAYS OVERNIGHT IN THE HOSPITAL AS A RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Stroke/CVA

  MAUDE report 19158555 ↗