ENROUTE Transcarotid Stent SR-0940-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00811311020508), received between Jun 23, 2017 and Jun 8, 2026 — classified as 5 deaths, 48 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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 58 reports, in the reporter's own words as published by the FDA.

• DeathJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STROKE SYMPTOMS, BLOOD CLOT, AND A HEMORRHAGIC BLEED, WHICH REQUIRED ADDITIONAL INTERVENTION. THE PATIENT SUBSEQUENTLY DIED. THE PATIENT PRESENTED AS SYMPTOMATIC FOR A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID STENT SYSTEM (TSS) WAS SELECTED FOR USE. DURING THE PROCEDURE, A STATIONARY PROLAPSE WAS IDENTIFIED AT THE DISTAL END OF THE DEPLOYED STENT. THE PHYSICIAN ELECTED TO RELINE THE VESSEL WITH AN ADDITIONAL ENROUTE STENT. REPEAT DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND ORTHOGONAL IMAGING DEMONSTRATED RESOLUTION OF THE PROLAPSE WITH NO RESIDUAL FINDINGS, AND THE PROCEDURE WAS COMPLETED. FOLLOWING COMPLETION OF A NEUROLOGICAL EXAMINATION, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. APPROXIMATELY ONE HOUR AFTER ARRIVAL IN THE ICU, THE PATIENT DEVELOPED THROMBOSIS AND A HEMORRHAGIC BLEED AND SUBSEQUENTLY UNDERWENT THROMBECTOMY AND COILING. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD NOT BEEN TAKING PRESCRIBED BLOOD-THINNER MEDICATIONS. THE PATIENT WAS PLAVIX-RESISTANT AND HAD MISSED TWO DOSES OF BRILINTA ON THE SATURDAY AND SUNDAY PRIOR TO THE PROCE

  Patient problems: Intracranial Hemorrhage; Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 25437404 ↗
• InjuryJun 2, 2026Positioning Problem

  IT WAS REPORTED THAT NO FLOW WAS OBSERVED FOLLOWING STENT DEPLOYMENT. THE PATIENT PRESENTED AS ASYMPTOMATIC FOR A RIGHT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID STENT (TSS) SYSTEM WAS SELECTED FOR USE. FOLLOWING STENT DEPLOYMENT AT THE LESION SITE, IMAGING DEMONSTRATED CONTRAST INFLOW INTO THE STENT WITH NO DISTAL OUTFLOW BEYOND THE STENT. AN ADDITIONAL ENROUTE STENT WAS PLACED, FOLLOWED BY DEPLOYMENT OF A THIRD ENROUTE STENT; HOWEVER, SUBSEQUENT IMAGING CONTINUED TO DEMONSTRATE ABSENCE OF DISTAL FLOW. A CUTDOWN WITH STENT EXPLANTATION WAS PERFORMED BY THE PHYSICIAN; HOWEVER, THE NUMBER OF STENTS REMOVED COULD NOT BE CONFIRMED. THE PHYSICIAN SUBSEQUENTLY PROCEEDED WITH CAROTID ENDARTERECTOMY (CEA). IMAGING CONTINUED TO DEMONSTRATE LACK OF FLOW TO THE BRAIN. THE PATIENT REQUIRED HOSPITALIZATION BEYOND THE STANDARD OF CARE. THE PATIENT OUTCOME WAS REPORTED AS EXPECTED TO FULLY RECOVER. UPON REVIEW OF THE PRE-PROCEDURE COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY, THERE WAS CONCERN THAT THE TREATED LESION MAY HAVE REPRESENTED LONG-SEGMENT DISEASE. IT WAS FURTHER REPORTED THAT IT WAS UNCLEAR WHETHER THE STENTS WERE DEPLOYED WITHIN THE TRUE LUMEN OR FALSE LUMEN.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 25365595 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM HAD UNRAVELED AND A BLACK FRAGMENT WAS FOUND IN THE NEUROPROTECTION SYSTEM(NPS) FILTER FOLLOWING THE PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED WITH NO ISSUES REPORTED. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE SPRING HAD UNRAVELED AT THE DISTAL TIP. POST PROCEDURE, A BLACK FRAGMENT WAS FOUND IN THE NPS FILTER. UPON FURTHER INSPECTION OF THE STENT DELIVERY SYSTEM, THE BLACK FRAGMENT FOUND IN THE FILTER APPEARS TO HAVE BROKEN OFF THE DELIVERY SYSTEM. NO INTERVENTION WAS REQUIRED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311227 ↗
• DeathMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HEMORRHAGIC STROKE OCCURRED APPROXIMATELY TWO HOURS POST-PROCEDURE, AND THE PATIENT SUBSEQUENTLY EXPIRED. THE PATIENT PRESENTED AS SYMPTOMATIC WITH A LEFT HEMISPHERIC CEREBROVASCULAR ACCIDENT (CVA) INVOLVING THE LEFT INTERNAL CAROTID ARTERY DISTRIBUTION, AS WELL AS A RIGHT HEMISPHERIC CVA RELATED TO RIGHT INTERNAL CAROTID ARTERY AND MIDDLE CEREBRAL ARTERY STENOSIS ONE MONTH PRIOR TO THE LEFT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID STENT SYSTEM (TSS) WAS SELECTED FOR USE. DURING THE PROCEDURE, BLOOD PRESSURE WAS REPORTED TO BE ACCEPTABLE PRIOR TO UNCLAMPING, WITH SYSTOLIC READINGS IN THE 150S. POST-OPERATIVELY, THE PATIENT'S BLOOD PRESSURE WAS REPORTED TO BE ELEVATED (SYSTOLIC READINGS IN THE 180S), AND IT WAS NOTED THAT THE POST-OPERATIVE ORDER SET WAS ENTERED INCORRECTLY TO MONITOR HEART RATE RATHER THAN BLOOD PRESSURE. POST-PROCEDURE, THE PATIENT INITIALLY PASSED THE NEUROLOGICAL CHECK AND WAS FOLLOWING COMMANDS. APPROXIMATELY TWO HOURS POST-OPERATIVELY, THE PATIENT DEVELOPED NEUROLOGICAL SYMPTOMS AND BECAME UNRESPONSIVE TO VOICE OR TOUCH. THE PATIENT REMAINED INTUBATED WITH AN EXTERNAL VENTRICULAR DRAIN (EVD) IN PLACE. THE

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhagic Stroke; High Blood Pressure/ Hypertension

  MAUDE report 24590205 ↗
• InjuryFeb 23, 2026Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS PLACED OUTSIDE OF THE TARGET LESION, RESULTING IN DEVICE EXPLANT AND ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE TRYING TO ENGAGE THE EXTERNAL CAROTID ARTERY (ECA), THE 0.035" J-TIP GUIDEWIRE INADVERTENTLY MOVED LIKELY CAUSING AN INJURY TO THE VESSEL. AN ENROUTE 0.014 GUIDEWIRE WAS USED TO WIRE THE INTERNAL CAROTID ARTERY (ICA) BUT IT COULD NOT CROSS THE LESION, A V-14 GUIDEWIRE WAS USED SUCCESSFULLY AND STENT WAS PLACED. FINAL IMAGING REVEALED THAT THE STENT WAS PLACED OUTSIDE THE ICA. THE PHYSICIAN EXPLANTED THE STENT AND NOTED THAT THE STENT HAD PERFORATED THE ICA. THE PHYSICIAN PERFORMED A CAROTID ENDARTERECTOMY (CEA) AND PLACED A PATCH TO TREAT THE PERFORATION. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Perforation

  MAUDE report 24420915 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AFTER THE TCAR PROCEDURE, THE PATIENT EXPERIENCED RIGHT-HAND TINGLING, PERIPHERAL NEUROPATHY, AND ORTHOSTATIC HYPOTENSION. SUBSEQUENT IMAGING REVEALED A PATENT STENT AND TINY PUNCTATE INFARCT IN THE LEFT PRECENTRAL GYRUS. THE PHYSICIAN DIAGNOSED THE PATIENT WITH METABOLIC ENCEPHALOPATHY, AND THE PHYSICIAN BELIEVED THE EVENT WAS ATTRIBUTED TO ANESTHESIA AND POST OPERATION MANAGEMENT. NO MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT WAS DISCHARGED AT 48 HOURS AT BASELINE.

  Patient problems: Ischemia Stroke; Low Blood Pressure/ Hypotension; Neuropathy; Paresthesia

  MAUDE report 24323242 ↗
• InjuryJan 28, 2026Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DEPLOYED IN A DISSECTION PLANE, WHICH REQUIRED ADDITIONAL INTERVENTION AND DEVICE EXPLANTATION. THE PATIENT PRESENTED AS SYMPTOMATIC WITH SEVERE TORTUOSITY IN THE DISTAL RIGHT INTERNAL CAROTID ARTERY (ICA) FOR A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID STENT SYSTEM (TSS) WAS SELECTED FOR USE. DURING THE PROCEDURE, IMAGING REVEALED THAT THE STENT WAS DEPLOYED IN A DISSECTION PLANE. THE PHYSICIAN CONVERTED TO A CAROTID ENDARTERECTOMY (CEA) AND SURGICALLY EXPLANTED THE STENT. A SUCCESSFUL CEA WAS PERFORMED, AND THE PATIENT WAS NEUROLOGICALLY INTACT POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205657 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. BRILINTA WAS USED BASED ON THE P2Y12 INHIBITOR RESULTS FOR PLAVIX. HOWEVER, DAYS AFTER THE TCAR PROCEDURE, THE PATIENT EXPERIENCED APHASIA. NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Dysphasia; Stroke/CVA

  MAUDE report 23696843 ↗
• InjuryNov 18, 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, REQUIRING ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT EXPERIENCED NEUROLOGICAL DEFICIT. IMAGING PERFORMED REVEALED AN EMBOLIC STROKE IN THE LEFT HEMISPHERE AND THE PHYSICIAN NOTED THAT THE PROXIMAL END OF THE SECOND STENT WAS PLACED IN A DISSECTION PLANE IN THE COMMON CAROTID ARTERY (CCA). THE PHYSICIAN PERFORMED A CEA TO EXPLANT THE STENTS AND PATCHED THE CAROTID ARTERY.

  Patient problems: Ischemia Stroke

  MAUDE report 23582809 ↗
• InjuryNov 18, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC STROKE, REQUIRING ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT EXPERIENCED NEUROLOGICAL DEFICIT. IMAGING PERFORMED REVEALED AN EMBOLIC STROKE IN THE LEFT HEMISPHERE AND THE PHYSICIAN NOTED THAT THE PROXIMAL END OF THE SECOND STENT WAS PLACED IN A DISSECTION PLANE IN THE COMMON CAROTID ARTERY (CCA). THE PHYSICIAN PERFORMED A CEA TO EXPLANT THE STENTS AND PATCHED THE CAROTID ARTERY.

  Patient problems: Ischemia Stroke

  MAUDE report 23582708 ↗
• InjuryOct 20, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE STENT WAS COMPRESSED, AND THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE TARGET VESSEL WAS SIGNIFICANTLY CALCIFIED. DURING THE TCAR PROCEDURE, THERE WAS INADEQUATE IMAGING AND POST-DILATION AS A RESULT OF PATIENT AGITATION. APPROXIMATELY 45 MINUTES POST PROCEDURE, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE AND IMAGING IDENTIFIED CALCIUM COMPRESSING THE STENT. NEUROLOGY INTERVENTIONAL RADIOLOGISTS PERFORMED A THROMBECTOMY AND SUCCESSFULLY POST-DILATED THE STENT. NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 23336154 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STROKE OCCURRED. NO INTERVENTION HAS BEEN PERFORMED OR PLANNED. AN ENROUTE TRANSCAROTID STENT SYSTEM WAS SELECTED FOR USE. FOLLOWING THE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A STROKE. UPON WAKING, THE PATIENT EXHIBITED STROKE SYMPTOMS, SPECIFICALLY WEAKNESS. THE PATIENT WAS RESPONSIVE DURING THE POST-PROCEDURE NEUROLOGICAL CHECK; HOWEVER, RESPONSES APPEARED SLOWER THAN BASELINE. THE SYMPTOMS HAVE NOT COMPLETELY RESOLVED. THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT). NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 22947688 ↗
• MalfunctionJul 31, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE STENT WAS IN-FOLDING. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST TCAR PROCEDURE, THE PATIENT EXPERIENCED A HEADACHE AND AN ADDITIONAL COMPUTED TOMOGRAPHY (CT) WAS PERFORMED. HYPER PROFUSION AND SIGNS STROKE WERE NOT IDENTIFIED AND THE HEADACHE RESOLVED. IMAGING DID REVEAL THAT THE STENT HAD AN IN-FOLD APPEARANCE. ADDITIONAL INFORMATION PROVIDED BY BOSTON SCIENTFIC (BSC) SENIOR MEDICAL DIRECTOR INDICATED THAT THE PATIENTS COMMON CAROTID ARTERY, DISTAL TO THE STENTED SEGMENT, HAD EXTENSIVE DISEASE. THE PATIENT HAD A HISTORY OF THYROID SURGERY, AND THE NECK WAS NOTED TO BE THICK AND LIKELY FIBROTIC. THE PATIENT HAS UNTREATED HEPATITIS C AND HUMAN IMMUNODEFICIENCY VIRUS (HIV), AFFECTING THE PATIENT'S VASCULATURE. THE STENT COLLAPSED DUE TO THICK TISSUE AND NOT DUE TO CALCIFICATION. ALTHOUGH THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC FROM THE STENT COLLAPSE, THE PATIENT WAS TREATED WITH MEDICATION. THE REASON FOR MEDICATION BEING ADMINISTERED AND THE DETAILS OF MEDICATION TYPE AND DOSE WERE NOT REPORTED TO BSC.

  Patient problems: Headache; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674793 ↗
• DeathJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BRAIN BLEED WITHIN 24 HOURS OF THE TCAR PROCEDURE AND SUBSEQUENTLY PASSED AWAY. THE PATIENT WAS PRESENTED AS SYMPTOMATIC WITH A VERY TIGHT STENOSIS FOR A HIGH SURGICAL RISK FOR THE RIGHT-SIDED TCAR PROCEDURE. THE TCAR PROCEDURE WAS COMPLETED. FOLLOWING THE PROCEDURE, ACCORDING TO THE NURSE PRACTITIONER, THE PATIENT RECEIVED LOVENOX POST-PROCEDURE. THE PATIENT WAS ALERT AND FOLLOWING COMMANDS BUT EXHIBITED SIGNS OF LEFT ARM WEAKNESS, WHICH WAS PRESENT PRIOR TO THE PROCEDURE, ACCORDING TO THE PHYSICIAN. DURING THE NIGHT, THE PATIENT DEVELOPED A BRAIN BLEED, AND THE FOLLOWING MORNING, THE FAMILY OPTED TO REPLACE THE CARE CONSENT WITH COMFORT CARE. A CT SCAN AND NEUROLOGY CONSULTATION WERE ALSO CONDUCTED. THE PATIENT ULTIMATELY EXPIRED.

  Patient problems: Hemorrhagic Stroke; Muscle Weakness/Atrophy

  MAUDE report 22395410 ↗
• MalfunctionJun 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE STENT FRACTURED AND A DISSECTION OCCURRED. THE PATIENT UNDERWENT A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE ON (B)(6) 2019 AND WAS IMPLANTED WITH AN ENROUTE TRANSCAROTID STENT. ON (B)(6) 2025, THE PATIENT PRESENTED FOR SCHEDULED FOLLOW-UP. THE PATIENT WAS COMPLETELY ASYMPTOMATIC, WITH NO ABNORMAL NECK PHYSICAL FINDINGS. HOWEVER, THE DUPLEX ULTRASOUND SCAN REVEALED AN APPARENT STENT FRACTURE WITH A SMALL DISSECTION OUTSIDE OF THE STENT AND CAROTID. A REPEAT ULTRASOUND WAS PERFORMED ON (B)(6) 2025, WHICH CONFIRMED THE SAME FINDINGS. NO ADDITIONAL INTERVENTION WAS PLANNED AS A RESULT OF THE ULTRASOUND FINDINGS. THE PATIENT EXPERIENCED NO FURTHER COMPLICATIONS.

  Patient problems: Vascular Dissection

  MAUDE report 22181583 ↗
• InjuryMay 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS COMPRESSED, RESULTING IN ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE ON (B)(6) 2024. THE LESION WAS PREDILATED USING A BALLOON, AND THE STENT WAS PLACED. THE STENT WAS POST-DILATED USING A BALLOON WITH NO REPORTED ISSUES. DURING ROUTINE FOLLOW-UP, CTA IMAGING REVEALED THE STENT HAD GONE DOWN AND WAS COMPRESSED IN MORE THAN ONE AREA. ON (B)(6) 2025, THE PATIENT UNDERWENT A REDO TCAR PROCEDURE. AN AGGRESSIVE PRE-DILATATION OF THE STENT WAS PERFORMED USING A NON-BOSTON SCIENTIFIC BALLOON. NO ADDITIONAL STENT WAS PLACED. BLOOD FLOW IMPROVED, AND THE PATIENT WOKE UP FINE AND WAS MOVING THEIR ARMS AND LEGS. THE PATIENT WAS ADMINISTERED LEVOPHED TO KEEP SYSTOLIC BLOOD PRESSURE ABOVE 100 OVERNIGHT BUT WAS TAKEN OFF THE MEDICATION BY 12PM THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984557 ↗
• InjuryFeb 18, 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 PASSED THE POST PROCEDURE NEUROLOGICAL CHECK, BUT EXPERIENCED STROKE SYMPTOMS APPROXIMATELY EIGHT HOURS LATER. IMAGING REVEALED AN EMBOLIC EVENT WITH NEW WHITE LESIONS ON THE TREATED SIDE AND DID NOT REVEAL ANY ABNORMALITIES WITH THE STENT. THE PATIENT'S SYMPTOMS LASTED FOR 48 HOURS BEFORE RETURNING TO BASELINE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS SWITCHED TO BRILLINTA TWENTY DAYS PRIOR TO THE TCAR PROCEDURE BECAUSE A P2Y12 PLATELET FUNCTION TEST REVEALED THE PATIENT WAS A NON-RESPONDER WITH A PRU VALUE OF 267. 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: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 21397038 ↗
• InjuryJun 26, 2024Adverse 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, DURING THE NEUROLOGICAL EXAM, THE PATIENT WAS NOT MOVING HIS CONTRALATERAL LIMBS. IMAGING REVEALED AN OCCLUDED VESSEL, AND THE PHYSICIAN EXPLANTED THE STENTS AND CONVERTED THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). AFTER EXPLANATION OF THE STENT, IT WAS CONFIRMED THAT THERE WAS NO THROMBUS WITHIN THE STENT. DURING THE CEA PROCEDURE, IMAGING FURTHER REVEALED A CLOT OCCLUDING THE DISTAL INTERNAL CAROTID ARTERY (ICA) FOR WHICH THE PHYSICIAN PERFORMED A THROMBECTOMY USING A THIRD-PARTY ASPIRATION CATHETER. THE PATIENT'S STROKE SYMPTOMS HAVE COMPLETELY RESOLVED. IT WAS NOTED THAT THIS PATIENT HAD PRESENCE OF INTRALUMINAL THROMBUS EXTENDING TO THE PETROUS RIDGE AT THE SKULL BASE. THE ENROUTE TRANSCAROTID STENT SYSTEM IFU WARNS UNDER THE 'PATIENT SELECTION WARNINGS' : "SAFETY AND EFFECTIVENESS OF THE ENROUTE TRANSCAROTID STENT SYSTEM HAS NOT YET BEEN ESTABLISHED FOR PATIENTS WITH EVIDENCE OF INTRALUMINAL THROMBUS THOUGHT TO INCREASE THE RISK OF PLAQUE FRAGMENTATION AND DISTAL EMBOLIZATION". HOWEVER, THESE LESIONS ARE NOT CONTRAINDICATED IN THE IFU. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EV

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

  MAUDE report 19620452 ↗
• InjuryMay 14, 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, IMAGING REVEALED A FLAP OF DISEASE AT THE DISTAL END OF THE ENROUTE TRANSCAROTID STENT AND COMMON CAROTID ARTERY WAS OCCLUDED. FURTHER, IT WAS NOTED THAT THERE WAS THROMBUS PRESENT ON THE RIGHT SIDE OF THE STENT. THE PHYSICIAN PERFORMED A STENT EXPLANT AND CONVERTED TO A CAROTID ENDARTERECTOMY PROCEDURE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE OR NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 19312152 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A STROKE WITHIN 48 HOURS AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IMAGING REVEALED STENT WAS THROMBOSED. THE PATIENT WAS PLACED ON HEPARIN DRIP AND NO ADDITIONAL INTERVENTION WAS PERFORMED. FURTHER, ADDITIONAL INFORMATION INDICATED THAT EIGHT DAYS POST-TCAR PROCEDURE, THE PATIENT EXPIRED ON PALLIATIVE CARE. THE PHYSICIAN STATED THAT THE PRIMARY CAUSE OF DEATH WAS STROKE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE OR NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

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

  MAUDE report 19272044 ↗
• InjuryMay 3, 2024Adverse 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 DYSPHASIA AND RIGHT LEG WEAKNESS. IMAGING REVEALED MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION, AND IT WAS NOTED THAT THE CAROTID STENT WAS NOT PLACED DISTAL TO COVER THE LESION. THE PHYSICIAN PERFORMED SUCTION THROMBECTOMY, EXTENDED THE CAROTID STENT AND PLACED AN ADDITIONAL STENT TO COVER THE LESION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLIANT WITH ASPIRIN AND WAS LOADED WITH ASPIRIN PRIOR TO TCAR PROCEDURE. THE PATIENT HAS RETURNED TO BASELINE WITH NO DEFICITS. BASED ON THIS INFORMATION, IT IS UNCLEAR IF THE EVENT IS DUE TO DAPT NEGLIGENCE BY THE PATIENT, RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE AND WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

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

  MAUDE report 19241474 ↗
• MalfunctionApr 26, 2024Difficult to Remove; Material Deformation; Unintended Movement; Difficult to Remove; Material Deformation; Unintended Movement

  THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO UPDATE THE H11 DEVICE INVESTIGATION RESULTS FOR THE INITIAL REPORT SUBMITTED ON 04/26/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19196933 ↗
• InjuryApr 16, 2024Adverse 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, A SYMPTOMATIC PATIENT PRESENTED WITH THE SAME STROKE SYMPTOMS (DISORIENTATION AND SPEECH ISSUES) AND HAD STENT THROMBOSIS. THIS PATIENT HAD A VERY TIGHT LESION AND CALCIUM BURDEN. THE PHYSICIAN ADMINISTERED THROMBOLYTICS FOR SHORT TERM AND THE STENT WAS RE-BALLOONED TWO DAYS POST PROCEDURE. THE PATIENT'S STROKE SYMPTOMS HAVE RESOLVED, AND HE IS BACK TO BASELINE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL COMPLICATIONS, PATIENT RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Confusion/ Disorientation; Ischemia Stroke; Speech Disorder; Thrombosis/Thrombus

  MAUDE report 19121917 ↗
• InjuryApr 2, 2024Adverse 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 AN ACUTE STROKE WITH STENT THROMBOSIS. THE PHYSICIAN PERFORMED A MECHANICAL THROMBECTOMY AND RE-BALLOONED THE STENT. THE PATIENT'S SYMPTOMS HAVE NOT YET RESOLVED AND THE PATIENT HAS RIGHT HEMIPARESIS AND APHASIA. A P2Y12 TEST WAS PERFORMED AND THE PATIENT WAS REPORTED TO BE A LOW RESPONDER TO CLOPIDOGREL, HOWEVER NO TEST RESULTS WERE PROVIDED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE OR NON-COMPLIANCE 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; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 19029543 ↗
• InjuryMar 28, 2024Adverse 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 ISCHEMIC STROKE AND THE STENT HAD THROMBOSED. IMAGING REVEALED SOME COMPRESSION IN STENT. A THROMBECTOMY WAS PERFORMED TO ADDRESS THE ISSUE. THERE WAS NO P2Y12 INHIBITOR TEST PERFORMED, AND IT IS UNKNOWN IF THE PATIENT'S SYMPTOMS HAVE COMPLETELY RESOLVED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, 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: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 19001044 ↗