ENROUTE Transcarotid Stent SR-1040-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00811311020539), received between Mar 14, 2019 and Sep 9, 2026 — classified as 3 deaths, 50 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 FDA recall record name this device's identifier.

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. Jan 13, 2021Class IITerminated

   Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.

   Z-1146-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Fracture

  Patient problems: Dysphasia; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 50702619 ↗
• DeathSep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient did not move their left side and imaging revealed a brain bleed. An ENROUTE Transcarotid Stent was selected for use in a right sided Transcarotid Artery Revascularization (TCAR) procedure. The patient had multiple risk factors including a high lesion however, the procedure was completed as planned and the stent looked great. During extubation, patient did not move their left side, and the Computed Tomography Angiography (CTA) imaging revealed a brain bleed. Additionally, it was reported that the patient experienced Cerebral Hyperfusion Syndrome. The physician stated that the neurosurgeon reported the patient was "unsurvivable."

  Patient problems: Cerebral Hyperperfusion Syndrome; Hemorrhagic Stroke

  MAUDE report 50679512 ↗
• DeathJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a hemorrhagic stroke. The patient also expired.The patient presented as asymptomatic for a right Transcarotid Revascularization (TCAR) procedure. An ENROUTE Transcarotid Stent (TSS) System was selected for use. Prior to discharge, the patient experienced a hemorrhagic stroke. The patient subsequently died. The official cause of death was reported as hemorrhage.

  Patient problems: Cerebral Hyperperfusion Syndrome; Hemorrhagic Stroke

  MAUDE report 50092674 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NARROWING IN THE STENT AT THE DISTAL SEGMENT, REQUIRING MEDICATION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT FOUR DAYS AFTER A TCAR PROCEDURE, THE PATIENT WENT TO ANOTHER HOSPITAL WITH STROKE AND SEIZURE. IMAGING PERFORMED SUGGESTED AN ACUTE POSTERIOR TEMPORAL CEREBROVASCULAR ACCIDENT (CVA). THE STENT WAS PATENT. FURTHER INFORMATION INDICATED THAT IMAGING SHOWED NO LEFT SIDED CVA AND CONFIRMED THE FINDINGS REPRESENTED AN OLD STROKE, WITH NO THROMBUS PRESENT IN THE STENT. THE PHYSICIAN BELIEVED THIS WAS A POST REPERFUSION SEIZURE. THE PATIENT IS NEUROLOGICALLY INTACT. IT WAS ALSO NOTED THAT THERE WAS NARROWING IN THE STENT AT THE DISTAL SEGMENT WHERE THE INTERNAL CAROTID ARTERY (ICA) WAS STENOSED PRIOR TO THE TCAR PROCEDURE. ELIQUIS WAS RECOMMENDED FOR THE PATIENT. AT THIS TIME, IT IS NOT CONFIRMED IF THE MEDICATION WAS GIVEN DUE TO RESTENOSIS OR POSSIBLE ATRIAL FIBRILLATION.

  Patient problems: Convulsion/Seizure; Reperfusion Injury; Restenosis

  MAUDE report 24932870 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION WAS IDENTIFIED REQUIRING AN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. UPON DEPLOYMENT OF THE STENT, THE ANGIOGRAM NOTED A SLIGHT BLUSH, INDICATING A DISSECTION AND REQUIRING AN ADDITIONAL STENT PLACEMENT. AFTER THE TCAR PROCEDURE, THE PATIENT WOKE UP NEUROLOGICALLY INTACT RESPONDING TO VERBAL COMMANDS TO MOVE THE RIGHT AND LEFT EXTREMITIES. HOWEVER, THIRTY HOURS POST PROCEDURE, THE PATIENT EXPERIENCED LEFT SIDED NEGLECT. THE PATIENT WAS SENT FOR FURTHER IMAGING. NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Stroke/CVA; Vascular Dissection

  MAUDE report 24395366 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE, REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE, AND THE PATIENT PASSED THE POST PROCEDURE NEURO CHECK. APPROXIMATELY EIGHTEEN HOURS POST PROCEDURE, THE PATIENT EXPERIENCED A STROKE, AND THROMBOSIS WAS IDENTIFIED WITHIN THE STENT. INTERVENTIONAL RADIOLOGY (IR) TOOK THE PATIENT BACK TO SURGERY TO ADDRESS THE STENT THROMBOSIS. AFTER AN UNKNOWN SERIES OF EVENTS, THE PATIENT UNDERWENT A CRANIOTOMY, AND REMAINED HOSPITALIZED AT THE TIME OF REPORTING. THE REASON FOR THE CRANIOTOMY WAS NOT REPORTED TO BOSTON SCIENTIFIC.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 23998101 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST TCAR PROCEDURE, THE PATIENT WOKE UP SLOWLY AND COULD NOT MOVE THEIR RIGHT UPPER AND LOWER SIDE. AFTER A FEW MINUTES THE PATIENT WAS ABLE TO FULLY MOVE THEIR RIGHT LEG AND WIGGLE THEIR TOES BUT DID NOT HAVE THE ABILITY TO MOVE THEIR RIGHT ARM OR HAND. IMAGING REVEALED A PATENT STENT; HOWEVER, THE PHYSICIAN WAS NOT ENTIRELY SATISFIED WITH THE STENTS APPEARANCE AND SUSPECTED PLAQUE PROLAPSE. FURTHER ANALYSIS OF THE IMAGING CLASSIFIED THE EVENT AS A THROMBOTIC STROKE. THE PATIENT WAS GIVEN TPA ((TISSUE PLASMINOGEN ACTIVATOR), AND NO FURTHER INTERVENTION WAS PERFORMED. AT THE TIME OF REPORTING, THE PATIENT'S LOWER EXTREMITY MOVEMENT HAD IMPROVED, BUT THERE HAD BEEN NO IMPROVEMENT IN UPPER EXTREMITY MOVEMENT.

  Patient problems: Confusion/ Disorientation; Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 23598079 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED STROKE SYMPTOMS BILATERALLY. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TCAR PROCEDURE. POST PROCEDURE, THE PATIENTS BLOOD PRESSURE WAS AROUND BASE-LINE (127/60) AND THE PATIENT APPEARED STABLE. THE PATIENT PASSED THE POST-PROCEDURE NEUROLOGICAL CHECK. THE NEXT DAY, THE PATIENT EXPERIENCED BILATERAL STROKE SYMPTOMS. NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Stroke/CVA

  MAUDE report 23427278 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT HAD THROMBOSED. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED UNSTABLE HEMODYNAMICS. POST TCAR PROCEDURE, THE PATIENT'S LEFT SIDED MOTOR SKILLS WERE DEFICIENT. IMAGING REVEALED THAT THE DISTAL HALF OF THE STENT HAD OCCLUDED. HEPARIN WAS ADMINISTERED TO THE PATIENT, AND THE STENT WAS EXPLANTED. PATIENT OUTCOME INFORMATION WAS NOT AVAILABLE.

  Patient problems: High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Paralysis; Thrombosis/Thrombus

  MAUDE report 23290752 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS PREVIOUSLY SYMPTOMATIC IN RIGHT HEMISPHERE. THE PHYSICIAN WAS USING NEUROIMAGING/NEUROMONITORING (EVALUATION OF MOTOR FUNCTIONS) DURING THE TCAR PROCEDURE. THE FINAL COMPLETION ANGIOGRAM SHOWED PLAQUE PROLAPSE; THEREFORE, A SECOND STENT TO WAS ADDED TO RELINE THE FIRST STENT. NEUROMONITORING WENT OFF TO THE LEFT ARM AND LEFT LEG DURING PLACEMENT OF THE SECOND STENT. APPROXIMATELY ONE HOUR POST PROCEDURE, AS THE PATIENT WAS WAKING UP, THE PATIENT EXPERIENCED LEFT ARM WEAKNESS. MAGNETIC RESONANCE IMAGING (MRI) REVEALED THAT THE PATIENT HAD EXPERIENCED A RIGHT SIDED EMBOLIC STROKE. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. NO INTERVENTION WAS REQUIRED DUE TO THE STROKE EVENT.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion

  MAUDE report 22913822 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A THROMBOTIC STROKE TWO HOURS POST PROCEDURE REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. TWO HOURS POST PROCEDURE THE PATIENT EXPERIENCE STROKE LIKE SYMPTOMS. THE PHYSICIAN EXPLANTED THE STENT, PATCHED THE RIGHT CAROTID ARTERY AND NOTED VERY SMALL PLATELET AGGREGATES AT THE DISTAL END OF THE STENT. IMAGING WAS PERFORMED AND THERE WERE NO ABNORMALITIES. THE PATIENT WOKE UP NEUROLOGICALLY INTACT AFTER THE PROCEDURE WITH NO SYMPTOMS.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 22913494 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE (220 SYSTOLIC) AND STROKE SYMPTOMS. IMAGING REVEALED AN OCCLUDED STENT. THROMBECTOMY WAS PERFORMED AND THE PATIENT WAS ADMINISTERED A CANGRELOR INFUSION AND SWITCHED TO BRILINTA. THE PATIENT HAS MADE A COMPLETE RECOVERY. ADDITIONAL INFORMATION STATED THAT THE PATIENT MIGHT HAVE BEEN RESISTANT TO PLAVIX BUT WAS NOT CONFIRMED AS A P2Y12 PLATELET FUNCTION TEST WAS NOT PERFORMED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: High Blood Pressure/ Hypertension; Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 21506778 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED RIGHT HAND WEAKNESS. ADDITIONAL INFORMATION STATED THE PATIENT HAS MADE A COMPLETE RECOVERY, HOWEVER THE TIMELINE OF THE RECOVERY IS UNCLEAR AND IT IS NOT BELIEVED TO BE A STROKE BY THE PHYSICIAN. SINCE THE SYMPTOM OF CONTRALATERAL HAND WEAKNESS IS OFTEN ASSOCIATED WITH STROKE AND PATIENT'S RECOVERY TIMELINE IS UNCLEAR, AND IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED AGAINST THE TSS OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 21351209 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EIGHT HOURS AFTER THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED APHASIA AND HAD A STROKE. POST-OPERATION IMAGING DID NOT REVEAL ANY ABNORMALITIES AND THE STENT WAS NOTED TO BE WIDELY PATENT. HOWEVER, A REVIEW OF THE MAGNETIC RESONANCE IMAGING (MRI) REVEALED AN EMBOLIC EVENT. THE PATIENT'S SYMPTOMS HAVE NOT RESOLVED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Dysphasia; Ischemia Stroke

  MAUDE report 21339551 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED AN INCREASED WEAKNESS IN THEIR LEFT ARM. IMAGING REVEALED THAT THE STENT WAS OCCLUDED AND THE PHYSICIAN ELECTED TO EXPLANT THE STENT. THE PATIENT'S SYMPTOMS IMPROVED AND THEY ALMOST RETURNED TO BASELINE THE NEXT MORNING. ADDITIONAL INFORMATION STATED THAT THE PHYSICIAN DETERMINED THAT THE SYMPTOMS EXPERIENCED BY THE PATIENT WERE AN EXTENSION OF THE SYMPTOMS FROM A PREVIOUS STROKE AND THERE WERE NO NEW SYMPTOMS POST TCAR PROCEDURE. THE REPORTED EVENT OF LEFT ARM WEAKNESS IS RELATED TO THE PATIENT'S RECRUDESCENCE OF SYMPTOMS (PRE-EXISTING CONDITION) AND NOT RELATED TO THE TCAR PROCEDURE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT OF A THROMBOSED STENT REQUIRING SURGICAL INTERVENTION IS DUE TO PROCEDURAL COMPLICATIONS, PATIENT RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE IT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Muscle Weakness/Atrophy; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21154638 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED LEFT-SIDED UPPER EXTREMITY WEAKNESS AND SEIZURES. IMAGING REVEALED THROMBUS WITHIN THE STENT. THE PATIENT'S SEIZURES HAVE RESOLVED HOWEVER, THE STATUS OF THE PATIENT'S UPPER EXTREMITY MUSCLE WEAKNESS IS UNKNOWN. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Convulsion/Seizure; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 20078509 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED LEFT-SIDED UPPER EXTREMITY WEAKNESS AND SEIZURES. IMAGING REVEALED THROMBUS WITHIN THE STENT. THE PATIENT'S SEIZURES HAVE RESOLVED HOWEVER, THE STATUS OF THE PATIENT'S UPPER EXTREMITY MUSCLE WEAKNESS IS UNKNOWN. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Convulsion/Seizure; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 20078499 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS VISUALIZED POST STENT PLACEMENT. AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 19823305 ↗
• InjuryJul 3, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, UPON WAKING, THE PATIENT EXPERIENCED LEFT-SIDED WEAKNESS. FURTHER, IT WAS NOTED THAT THE ARTERIAL LINE WAS NOT TRANSMITTING AND THERE WAS DIFFICULTY GETTING A NON-INVASIVE BLOOD PRESSURE. DUE TO THE LEFT SIDED WEAKNESS, BLOOD PRESSURE & STRIDOR WITH BREATHING ISSUE, A STROKE CODE WAS INITIATED, AND THE PHYSICIAN PLACED A FEMORAL ARTERIAL LINE TO MAINTAIN BLOOD PRESSURE. IMAGING REVEALED PERFUSION DEFICIT AND DEFORMATION OF THE STENT POST-IMPLANTATION. THE DEFORMATION OF THE STENT WAS LATER FOUND TO BE DUE TO PATIENT'S ANATOMY AND CALCIFICATION. DURING THE INITIAL TCAR, THE PHYSICIAN CHOSE TO PRE-DILATE THE LESION, BUT NOT TO POST-DILATE THE STENT. THUS, THE PHYSICIAN ELECTED TO RE-TREAT THE PATIENT VIA TCAR TO POST-DILATE THE STENT. AFTER THE TREATMENT, THE PATIENT'S MOVEMENT ON THE LEFT SIDE IMPROVED. THE PHYSICIAN INITIALLY BELIEVED THE PATIENT HAD A PERFUSION DEFICIT AND STROKE, BUT MRI IMAGING WAS NEGATIVE FOR STROKE. CT PERFUSION INDICATED STENT PATENCY WITH NO EMBOLIZATION, PLAQUE PROLAPSE OR THROMBUS. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PA

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 19669392 ↗
• InjuryJun 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED UP TO THE LESION IN THE LEFT INTERNAL CAROTID ARTERY (ICA). DURING DEPLOYMENT, THE USER PULLED THE DEVICE CAUSING THE STENT TO DEPLOY AT AN UNINTENDED LOCATION. THE ANGIOGRAM AFTER STENT DEPLOYMENT REVEALED THE STENT TO BE AT AN INCORRECT LOCATION AS 80% OF THE STENT WAS DEPLOYED WITHIN THE SHEATH, AND 20% OF THE STENT WAS DEPLOYED IN THE VESSEL. ADDITIONAL INFORMATION STATED THAT A DISSECTION WAS ALSO VISUALIZED ON IMAGING IN THE DISTAL ICA, WHICH IS OF NO RELEVANCE TO THE REPORTED EVENT, AS A DISSECTION IN THE DISTAL ASPECT OF THE ICA WOULD NOT AFFECT THE DEPLOYMENT OF THE STENT IN THE COMMON CAROTID ARTERY (CCA). THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO CAROTID ENDARTERECTOMY (CEA) AND THE STENT WAS EXPLANTED SURGICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473069 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 50 DAYS AFTER A LEFT TCAR PROCEDURE, THE PATIENT WAS FOUND UNRESPONSIVE AND DROOLING. THIS PATIENT WAS SYMPTOMATIC FROM A MIDDLE CEREBRAL ARTERY (MCA) REGION STROKE PRIOR TO TRANSCAROTID ARTERY REVASCULARIZATION PROCEDURE. IMAGING REVEALED INTRALUMINAL THROMBOTIC DEBRIS WITHIN THE STENT. THE PATIENT WAS ADMITTED TO A STROKE REHABILITATION FACILITY AND CONTINUED TO EXHIBIT STROKE SYMPTOMS (WORD FINDING AND WEAKNESS). IT WAS ALSO REPORTED THAT THE PATIENT HAD A BRADYCARDIC EVENT IN THE REHABILITATION FACILITY, HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONALLY, IT WAS NOTED THAT THIS PATIENT WAS ON TRIPLE THERAPY POST TCAR PROCEDURE (ELIQUIS, ASPIRIN AND PLAVIX) AND HAD DISCONTINUED ASPIRIN THREE WEEKS POST PROCEDURE. THE PATIENT WAS RESUMED ON ASPIRIN AND PRESCRIBED BRILINTA. THE PATIENT'S SYMPTOMS HAVE NOT YET RESOLVED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO DAPT NON-ADHERENCE, PATIENT'S UNDERLYING CONDITION, RESISTANCE TO MEDICATION OR A SILK ROAD MEDICAL DEVICE, HENCE, THIS EVENT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Dysphasia; Ischemia Stroke; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 19347672 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WOKE UP WITH LEFT ARM WEAKNESS. IMAGING REVEALED ACUTE STENT THROMBOSIS AND THE PHYSICIAN ELECTED TO PERFORM THROMBECTOMY. THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY (DAPT), AND IT IS UNCLEAR IF A P2Y12 PLATELET FUNCTION TEST WAS PERFORMED. FURTHER, IT WAS NOTED THAT THE PATIENT WAS HYPOTENSIVE FOR APPROXIMATELY 6 MINUTES AND HAD HEART RATE VARIABILITY POST TCAR. THE PATIENT'S SYMPTOMS HAVE IMPROVED, BUT THE PATIENT HAD NOT MADE A COMPLETE RECOVERY. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS DUE TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Arrhythmia; Ischemia Stroke; Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 19240073 ↗
• InjuryApr 3, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT 9 DAYS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED MILD LEFT ARM WEAKNESS. THE SYMPTOMS HAVE NOT YET RESOLVED. IMAGING REVEALED STENT WAS OVALIZED (COMPRESSED) AND A DISSECTION WAS IDENTIFIED IN THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN DID NOT INDICATE WHICH DEVICE CAUSED THE DISSECTION AND NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE DISSECTION. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED STENT COMPRESSION AND STROKE SYMPTOMS ARE RELATED TO PATIENT'S RESISTANCE TO MEDICATION/NON-COMPLIANCE OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 19035694 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 34 DAYS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, DURING A ROUTINE FOLLOW UP VISIT, IMAGING REVEALED PROLAPSED PLAQUE AND MOBILE THROMBUS INSIDE THE ENROUTE TRANSCAROTID STENT. THE PATIENT WAS ASYMPTOMATIC AND WAS SWITCHED TO BRILLINTA AND IV HEPARIN. THE PHYSICIAN PLACED AN ADDITIONAL STENT VIA TCAR PROCEDURE TO ADDRESS THE ISSUE. THE PATIENT WAS NEURO INTACT POST INTERVENTION. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED THROMBUS IS RELATED TO PATIENT'S RESISTANCE TO MEDICATION/NON-COMPLIANCE OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18918645 ↗
• MalfunctionFeb 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT PRESENTED WITH PSEUDOANEURYSM AND LINEAR FRACTURE OF THE ENROUTE TRANSCAROTID STENT. THE PHYSICIAN PERFORMED TRANSFEMORAL CAROTID ARTERY STENTING (TF-CAS) AND PLACED AN ADDITIONAL STENT OVER THE FRACTURED ENROUTE STENT. THE CAUSE OF THE STENT FRACTURE AND PSEUDOANEURYSM IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPIRED FROM HEART ISSUES. THE REPORTED EVENT OF DEATH IS NOT RELATED TO THE TCAR PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18636249 ↗