ENROUTE Transcarotid Neuroprotection System FG12531Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 00811311021062), received between Jun 11, 2024 and Aug 6, 2026 — classified as 2 deaths, 122 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jul 9, 2026Class IOpen, Classified

   Potential for arterial sheath tip separation or partial tip separation during use.

   Z-2978-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a dissection was identified requiring additional intervention. An ENROUTE Transcarotid Neuroprotection System was selected for use in a right sided Transcarotid Artery Revascularization (TCAR) procedure. During the procedure, a dissection was identified after arterial sheath placement. The physician was unable to advance the interventional wire through the dissection and elected to convert the procedure to a Carotid Endarterectomy (CEA).

  Patient problems: Vascular Dissection

  MAUDE report 50166918 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a dissection occurred, requiring additional intervention.The patient presented as asymptomatic for a left Transcarotid Revascularization (TCAR) procedure. An ENROUTE Transcarotid Neuroprotection System (NPS) was selected for use. During the procedure, a dissection was observed under fluoroscopy after placement of the arterial sheath. The physician elected to discontinue the TCAR procedure and convert to an open carotid endarterectomy (CEA). No patient complications were reported.

  Patient problems: Vascular Dissection

  MAUDE report 50087420 ↗
• MalfunctionJul 30, 2026Degraded

  It was reported the numerical markings 1, 2, and 3 were not present on the arterial sheath prior to the procedure. An ENROUTE Transcarotid Neuroprotection System was selected for use in a Transcarotid Artery Revascularization (TCAR) procedure. Upon removal of the sheath stopper for tunneling and before the arterial sheath was inserted into the patient, it was observed that the numerical pad-printed markings 1, 2, and 3 were not present on the sheath. The procedure was completed with the same device with no reported patient complications. No evidence of flaking was observed. The patient was stable post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085704 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED, REQUIRING STENT PLACEMENT. THE PATIENT PRESENTED AS SYMPTOMATIC FOR A LEFT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. DURING THE PROCEDURE, A PROXIMAL COMMON CAROTID ARTERY DISSECTION WAS NOTED ON ANGIOGRAM. THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE GUIDEWIRE AND BALLOON AND SUBSEQUENTLY SWITCHED TO A NON-BSC GUIDEWIRE AND CATHETER, WITH SLIGHT SHEATH MANIPULATION TO ACCESS THE TRUE LUMEN. A STENT WAS DEPLOYED TO COVER THE DISSECTION. THE PATIENT AWOKE NEUROLOGICALLY INTACT FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 25630743 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED RESULTING IN ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN THE LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT AFTER ARTERIAL SHEATH PLACEMENT, THERE WAS DIFFICULTY ADVANCING THE GUIDEWIRE AND IMAGING REVEALED THE ARTERIAL SHEATH APPEARED TO BE AGAINST BACK WALL OF THE ARTERY. THE ARTERIAL SHEATH WAS RE-POSITIONED BUT THE PHYSICIAN WAS UNABLE PASS THE WIRE AROUND THE DISSECTION. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA) AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Vascular Dissection

  MAUDE report 25512809 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED RETROPERITONEAL AND INTRAPERITONEAL BLEEDING. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN A LEFT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS. POST-PROCEDURE, IT WAS REPORTED THAT THE PATIENT DEVELOPED RETROPERITONEAL AND INTRAPERITONEAL BLEEDING. THE PATIENT RECEIVED THREE UNITS OF BLOOD OVERNIGHT AND INTO THE MORNING. THE PHYSICIAN SUSPECTED THE BLEEDING ORIGINATED FROM THE VENOUS ACCESS SITE, HOWEVER, THIS WAS NOT CONFIRMED. THE PATIENT REMAINS ALERT AND ORIENTED AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25449500 ↗
• MalfunctionJun 9, 2026Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT THE ARTERIAL SHEATH WAS DIFFICULT TO INSERT, AND THE TIP WAS FOUND TO BE DAMAGED. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ENGAGE THE ARTERY WITH THE ARTERIAL SHEATH. THE ARTERIAL SHEATH WAS REMOVED AND INSPECTED, AND IT WAS NOTICED THAT THE TIP HAD A SLIGHT BEVEL. THERE WAS NO REPORT OF VESSEL INJURY AND A NEW NPS DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448733 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED, RESULTING IN ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN THE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, A DISSECTION OCCURRED IN THE COMMON CAROTID ARTERY (CCA) WHILE INSERTING THE ARTERIAL SHEATH. THE DISSECTION WAS TREATED WITH A STITCH. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PATIENT COMPLICATIONS. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Vascular Dissection

  MAUDE report 25368554 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED RESULTING IN ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN THE LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, A DISSECTION WAS NOTED AND A NON- BSC GUIDEWIRE FAILED TO CROSS THE LESION. THE PROCEDURE WAS CONVERTED TO A CAROTID ENDARTERECTOMY (CEA) AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Vascular Dissection

  MAUDE report 25249818 ↗
• DeathMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE POST PROCEDURE NEUROLOGICAL CHECK, THE PATIENT DISPLAYED MOVEMENT IN ALL FOUR EXTREMITIES HOWEVER, THEY WERE NOT EQUAL. THE PATIENT'S LEFT EXTREMITIES SHOWED WEAKNESS. IMAGING REVEALED A NEW EMBOLIC STROKE AND THE STENT APPEARED PATENT. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT PASSED AWAY WHILE AT THE REHABILITATION CENTER. THE OFFICIAL CAUSE OF DEATH WAS NOT PROVIDED, AND NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 25236663 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE PATIENT WAS HYPERTENSIVE. POST TCAR PROCEDURE, THE PATIENT EXPERIENCED A STROKE WITH SPEECH ISSUES, HYPOTENSION, AND OTHER UNKNOWN RIGHT SIDED SYMPTOMS. THE PATIENT WAS REPORTED TO HAVE BEEN ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. THE PATIENT WAS EXPECTED TO FULLY RECOVER BUT HAD NOT YET RECOVERED AT THE TIME OF REPORTING. NO FURTHER INFORMATION WAS PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC (BSC).

  Patient problems: High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Speech Disorder; Stroke/CVA; Unspecified Tissue Injury

  MAUDE report 25222708 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE ELECTROENCEPHALOGRAM (EEG) SIGNALS DAMPENED, BUT RETURNED TO BASELINE POST PROCEDURE. POST PROCEDURE THE PATIENT EXPERIENCED A STROKE WITH LEFT HEMIPARESIS UPON WAKING FROM ANESTHESIA. IMAGING WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. THE STROKE EVENT WAS ASSESSED BY A MEDICAL PROFESSIONAL AS INTOLERANCE TO FLOW REVERSAL DUE TO UNDERLYING ANATOMY AND CEREBRAL PHYSIOLOGY, RESULTING IN A HYPOPERFUSION EVENT. NO ADDITIONAL PROCEDURES WERE PERFORMED AND THE PATIENT SYMPTOMS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 25144848 ↗
• MalfunctionMar 31, 2026Break; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT THE ARTERIAL SHEATH WAS DIFFICULT TO INSERT, AND THE TIP WAS FOUND TO BE DAMAGED. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PHYSICIAN REPORTED THAT THE ARTERIAL SHEATH WAS DIFFICULT TO INSERT. POST PROCEDURE, THE ARTERIAL SHEATH WAS REMOVED AND INSPECTED, AND IT WAS NOTICED THAT THE BLACK TIP OF CATHETER WAS BENT TO SIDE AND THE PLASTIC LUMEN WAS EXPOSED. THERE WAS NO REPORT OF VESSEL INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747697 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. WITHIN TWO TO THREE HOURS POST PROCEDURE, THE PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS. THE PATIENT WAS ADMITTED AND EVALUATED IN NEUROINTERVENTIONAL RADIOLOGY, AND IT WAS REPORTED THAT IMAGING DID NOT REVEAL A STROKE. THE PHYSICIAN FELT THE PATIENT DID NOT TOLERATE FLOW REVERSAL WELL. NO INTERVENTION WAS REQUIRED AND THE PATIENT RETURNED TO BASELINE WITHIN DAYS AFTER THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 24706026 ↗
• MalfunctionMar 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE ARTERIAL SHEATH BROKE OFF. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE FOR A RIGHT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. DURING REMOVAL OF THE ARTERIAL SHEATH, THE BLACK TIP WAS DETACHED FROM THE SHEATH. THE DETACHED TIP WAS FOUND OUTSIDE THE BODY ON THE DRAPE. NO PATIENT COMPLICATIONS WERE REPORTED. THE BREAK WAS NOT PRESENT UPON PACKAGE OPENING NOR NOTICED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644348 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED AS A RESULT OF ARTERIAL SHEATH RESULTING IN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE ARTERIAL SHEATH OF THE NPS WAS INSERTED OVER THE 0.035 AMPLATZ J-WIRE AND AN ANGIOGRAM WAS PERFORMED. IMAGING REVEALED THAT THE ARTERIAL SHEATH HAD CAUSED A DISSECTION IN THE COMMON CAROTID ARTERY (CCA). AN ADDITIONAL STENT WAS PLACED TO TREAT THE DISSECTION IN THE CCA.

  Patient problems: Vascular Dissection

  MAUDE report 24619281 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EMBOLIC STROKE AFTER THE PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. POST PROCEDURE, DURING RECOVERY, THE PATIENT BLOOD PRESSURE DROPPED TO 69MMHG AND REMAINED HYPOTENSIVE FOR APPROXIMATELY SEVEN TO TEN MINUTES. THE NEXT DAY, THE PATIENT EXPERIENCED LEFT SIDE SYMPTOMS AND HAD A STROKE. IMAGING REVEALED NEW WHITE LESIONS (NWL) IN THE RIGHT HEMISPHERE, IN THE INTERNAL WATERSHED ZONES AND BETWEEN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) AND MIDDLE CEREBRAL ARTERY (MCA) TERRITORIES. NO INTERVENTION WAS PERFORMED AND THE STROKE SYMPTOMS WERE RESOLVED WITHIN FOUR DAYS.

  Patient problems: Ischemia Stroke; Low Blood Pressure/ Hypotension

  MAUDE report 24598195 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED AS A RESULT OF THE 0.035" J-WIRE RESULTING IN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AFTER THE INITIAL STENT HAD BEEN PLACED, THE ANGIOGRAM REVEALED A DISSECTION IN THE MID/DISTAL COMMON CAROTID ARTERY (CCA). THE PHYSICIAN ELECTED TO PLACE AN ADDITIONAL STENT TO SUCCESSFULLY COVER THE DISSECTION. THE PHYSICIAN REPORTED THAT AFTER A REVIEW OF ALL THE ANGIOGRAMS DURING THE PROCEDURE, THEY BELIEVE THE 0.035" J-WIRE OF THE NPS CAUSED THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 24585037 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED IPSILATERAL MONOCULAR PARTIAL BLINDNESS REQUIRING HOSPITALIZATION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. IT WAS REPORTED THAT TEN HOURS AFTER A TCAR PROCEDURE, THE PATIENT DEVELOPED IPSILATERAL MONOCULAR PARTIAL BLINDNESS. IMAGING RESULTS WERE NEGATIVE AND THERE WAS NO LARGE VESSEL OCCLUSION (LVO) NOTED. THE PATIENT IS CURRENTLY HOSPITALIZED AND IS BEING MEDICALLY MANAGED.

  Patient problems: Embolism/Embolus; Loss of Vision

  MAUDE report 24584091 ↗
• MalfunctionMar 6, 2026Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO INSERT AND WAS SUBSEQUENTLY NOTED TO BE DAMAGED. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ARTERIAL SHEATH WAS INSERTED INTO THE LEFT COMMON CAROTID ARTERY AND DID NOT HAVE CONTACT WITH THE DISTAL CAROTID LESION. RESISTANCE WAS ENCOUNTERED, PROMPTING REMOVAL OF THE SHEATH. UPON INSPECTION, THE SHEATH TIP WAS OBSERVED TO BE FLARED AND DAMAGED. THERE WAS NO DISSECTION OR VESSEL TRAUMA NOTED. A SECOND NPS WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531302 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERTENSION REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED AS SYMPTOMATIC AND UNDERWENT A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. UPON CLOSURE, THE PATIENT'S SYSTOLIC BLOOD PRESSURE BRIEFLY REACHED THE 200S, AND MEDICATION WAS ADMINISTERED TO CORRECT IT. A DELAYED NEUROMUSCULAR RESPONSE WAS OBSERVED, WITH ABSENCE OF TWITCH.

  Patient problems: High Blood Pressure/ Hypertension; Paralysis

  MAUDE report 24524726 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. THE PATIENT PRESENTED AS ASYMPTOMATIC FOR A LEFT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. DURING THE PROCEDURE, NEUROMONITORING DEMONSTRATED SIGNS OF CHANGE PRIOR TO CLAMPING, AFTER WHICH THE PHYSICIAN PROCEEDED WITH CLAMPING AND COMPLETED THE INTERVENTION. STROKE SYMPTOMS APPEARED IMMEDIATELY POSTOPERATIVELY ON THE RIGHT SIDE AND INCLUDED SPEECH INVOLVEMENT AS WELL AS RIGHT ARM AND RIGHT LEG DEFICITS. IMAGING CONFIRMED AN ISCHEMIC STROKE. ALL SYMPTOMS RESOLVED WITHIN ONE HOUR EXCEPT FOR PERSISTENT ARM WEAKNESS.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy; Speech Disorder

  MAUDE report 24513777 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EMBOLIC STROKE AFTER THE PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. POST PROCEDURE, BETWEEN ONE TO TWO HOURS, THE PATIENT EXPERIENCED LEFT ARM WEAKNESS AND HAD A STROKE. IMAGING PERFORMED REVELED PUNCTATE NEW WHITE LESIONS (NWL) IN THE HEAD OF THE RIGHT BASAL GANGLIA REGION, RIGHT LATERAL PERIVENTRICULAR REGION AND IN THE MOTOR STRIP. THERE WAS NO INTERVENTION PERFORMED AND THE PATIENT SYMPTOMS HAVE RESOLVED.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 24513456 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED, RESULTING IN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. UPON INSERTION OF THE ARTERIAL SHEATH, THE 0.035" J-TIP GUIDEWIRE WITHDREW RESULTING IN A DISSECTION OF THE RIGHT COMMON CAROTID ARTERY (RCCA). THE ARTERIAL SHEATH WAS REMOVED, AND THE PRE-CLOSE STITCH WAS TIED DOWN. A NEW PROLENE PRE-CLOSE STITCH WAS PLACED PROXIMAL TO ORIGINAL ACCESS SITE TO CONTINUE WITH THE TCAR PROCEDURE. AN ADDITIONAL ENROUTE STENT WAS PLACED IN THE RCCA TO COVER THE AREA OF DISSECTION. THE PROCEDURE WAS COMPLETED IN THE NORMAL FASHION, AND THE PHYSICIAN ANTICIPATED A NORMAL RECOVERY FOR THE PATIENT.

  Patient problems: Vascular Dissection

  MAUDE report 24513453 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC STROKE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS NOTED THAT THE PATIENT DID EXPERIENCE BLOOD PRESSURE FLUCTUATION, WITH VALUES OF 123/66MMHG DURING FLOW REVERSAL, 137/67MMHG DURING PRE-DILATATION, AND 115/59MMHG DURING STENT PLACEMENT. POST PROCEDURE, THE PATIENT DID NOT PASS THE NEUROLOGICAL CHECK AND DID NOT HAVE A RIGHT ARM RESPONSE. NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 24509121 ↗