ENROUTE Transcarotid Stent SR-1030-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00811311020522), received between Jan 23, 2021 and Sep 14, 2026 — classified as 2 deaths, 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (2 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50765895 ↗
• DeathSep 10, 2026Use of Device Problem; Positioning Problem

  It was reported that the patient developed an occlusion secondary to a dissection, requiring additional intervention. The patient subsequently suffered a stroke and later died.The patient presented as symptomatic for a left Transcarotid Artery Revascularization (TCAR) procedure. An ENROUTE Transcarotid Stent System (TSS) was selected for use. Following the procedure, imaging reportedly demonstrated sluggish flow toward the distal circulation; however, the flow was determined as acceptable, and the patient was closed. The patient later became symptomatic, and computed tomography angiography (CTA) identified occlusion of the left internal carotid artery (ICA) at the petrous and cavernous segments. A thrombectomy was performed but did not improve the patient's symptoms. Subsequently, stent removal and carotid endarterectomy (CEA) were performed. A repeat CTA reportedly demonstrated ICA dissection and a non-occlusive stroke, after which the patient was placed on comfort care. A subsequent CTA reportedly showed ischemic changes in the left frontal lobe. The patient later died, and the official cause of death not provided.Further review of the CTA images dated (b)(6)2026 identified contr

  Patient problems: Ischemia Stroke; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 50703259 ↗
• 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; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 25436563 ↗
• InjuryFeb 19, 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 RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. 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

  MAUDE report 24395356 ↗
• InjuryFeb 11, 2026Positioning Problem; Activation Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE, REQUIRING ADDITIONAL INTERVENTION.AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AFTER THE STENT WAS PLACED, THE PHYSICIAN WAS INSTRUCTED TO TAKE AN ORTHOGONAL VIEW, BUT DID NOT FEEL IT WAS NECESSARY. THE STENT APPEARED COMPLETELY OPEN. THE PATIENT WENT TO THE POST ANESTHESIA CARE UNIT (PACU) AND WAS DOING WELL THE NEXT MORNING. POST TCAR PROCEDURE, THE PATIENT EXPERIENCED A STROKE. SUBSEQUENT IMAGING REVEALED CALCIFICATION AT THE BASE OF THE STENT, WHICH IMPINGED ON THE STENT AND PREVENTED IT FROM OPENING COMPLETELY. ADDITIONALLY, IT WAS NOTED THAT THE STENT WAS POSITIONED TOO HIGH. THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL CENTER, AND THE ARTERY WAS REVASCULARIZED WITH ANOTHER STENT.

  Patient problems: Stroke/CVA

  MAUDE report 24314168 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A STROKE POST PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER THE PROCEDURE, THE PATIENT HAD A STROKE. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. THE SYMPTOMS HAVE NOT BEEN RESOLVED YET. AT THIS TIME, THE ETIOLOGY OF THE STROKE AND WHETHER ANY INTERVENTION WAS PERFORMED ARE UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE TO BOSTON SCIENTIFIC.

  Patient problems: Stroke/CVA

  MAUDE report 23658722 ↗
• MalfunctionNov 20, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED WITH THE STENT DELIVERY SYSTEM AND GUIDEWIRE. AN ENROUTE TC STENT SYSTEM 10MM X 30MM WAS SELECTED FOR USE WITH AN ENROUTE 0.014 GUIDEWIRE. AFTER SUCCESSFUL STENT DEPLOYMENT, WHEN REMOVING THE STENT DELIVERY SYSTEM, THE GUIDEWIRE CAME BACK AND WAS STUCK WITH THE DELIVERY SYSTEM. BOTH THE DELIVERY SYSTEM AND THE GUIDEWIRE WERE REMOVED TOGETHER AS A UNIT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610541 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT THROMBOSED AND THE PATIENT EXPERIENCED SPEECH ISSUES. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AFTER IMPLANTATION OF THE STENT, THERE WAS PLAQUE PROLAPSE IDENTIFIED AND THE PHYSICIAN PLACED AN ADDITIONAL STENT TO COVER THE PLAQUE PROLAPSE. THE DAY FOLLOWING THE TCAR PROCEDURE THE PATIENT EXPERIENCED SPEECH ISSUES AND IMAGING REVEALED THROMBUS WITHIN THE STENT. THE PATIENT WAS PLACED ON HEPARIN.

  Patient problems: Obstruction/Occlusion; Speech Disorder; Thrombosis/Thrombus

  MAUDE report 22978820 ↗
• 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 21351206 ↗
• InjuryOct 4, 2024Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, AFTER DEPLOYMENT OF THE FIRST ENROUTE STENT, THE PHYSICIAN CHOSE TO DEPLOY AN ADDITIONAL STENT TO COVER THE LESION. IMAGING REVEALED THAT THE SECOND STENT WAS PARTIALLY DEPLOYED OUTSIDE THE LEFT COMMON CAROTID ARTERY, AS THE SHEATH WAS ONLY 1-2 CM INSIDE THE VESSEL. THE PHYSICIAN EXPLANTED THE SECOND ENROUTE STENT, AND THE FOLLOWING ANGIOGRAM DID NOT REVEAL ANY ABNORMALITIES. THE PATIENT WAS NEUROLOGICALLY INTACT AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372057 ↗
• 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 19121948 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED NEUROLOGICAL CHANGES. IMAGING REVEALED THROMBUS IN THE STENT. THE PHYSICIAN ELECTED TO RE-LINE THE STENT WITH A 3RD PARTY STENT VIA TRANSFEMORAL APPROACH TO ADDRESS THE ISSUE. 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: Thrombosis/Thrombus

  MAUDE report 17584980 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WAS EXPERIENCED STROKE SYMPTOMS THAT INCLUDED WEAKNESS AND APHASIA. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING PERFORMED SHOWED THAT THE STENT WAS PATENT, AND THERE WAS NO ACUTE BLOCKAGE OR HEMORRHAGE. ADDITIONALLY, MAGNETIC RESONANCE IMAGING (MRI) REVEALED MIDDLE CEREBRAL ARTERY (MCA) INFARCTS. ADDITIONAL INFORMATION OBTAINED INDICATED THAT THE DURING THE TCAR PROCEDURE, THE PHYSICIAN BALLOONED THE OVERLAP ZONE BETWEEN THE TWO STENTS WITH A 6X30 BALLOON. ON THE ANGIOGRAM, PLAQUE IDENTIFIED ON ONE VIEW. A SECOND VIEW WAS TAKEN WITH CONTRAST INJECTED. WHEN THE PHYSICIAN WENT BACK TO THE FIRST VIEW, THE ORIGINAL IMAGE DID NOT LOOK THE SAME. NO FURTHER INTERVENTION WAS REPORTED, AND PATIENT WAS NOTED TO BE AT BASELINE TWO DAYS POST-PROCEDURE. AT THIS TIME, IT IS UNCLEAR IF THE STROKE SYMPTOMS EXPERIENCED BY THE PATIENT IS RELATED TO A DEVICE ISSUE HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke

  MAUDE report 14323525 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS IDENTIFIED ON THE LEFT INTERNAL CAROTID ARTERY DURING STENT PLACEMENT ANGIOGRAM WHICH LED THE PHYSICIAN TO INTERVENE BY COVERING THE DISSECTION WITH A SECONDARY STENT TO RESOLVE. PER SILK ROAD MEDICAL'S FIELD REPRESENTATIVE, IT WAS NOTED THAT THE PHYSICIAN WASN'T SURE IF THE DISSECTION WAS CAUSED BY THE BALLOON OR STENT, AND IT IS BELIEVED THAT THE PHYSICIAN LEANED TOWARD THE STENT. HOWEVER, HE DID NOT PERFORM IMAGING AFTER THE BALLOON ANGIOPLASTY SO THERE IS NO WAY TO BE CERTAIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT'S CLINICAL CONDITION AFTER THE PROCEDURE COMPLETION REMAINED NEUROLOGICALLY INTACT.

  Patient problems: Vascular Dissection

  MAUDE report 12551133 ↗
• InjuryJan 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER THE COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO APHASIA/SEIZURES. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DEMONSTRATED CRITICAL STENOSIS. THE PHYSICIAN REMOVED THE IMPLANTED STENTS DURING CAROTID REPAIR TO RESOLVE THE REPORTED ISSUE. THERE WAS NO CLINICAL HEMISPHERIC DEFICITS BUT SLOW CLEARING ENCEPHALOPATHY.

  Patient problems: Brain Injury; Convulsion/Seizure

  MAUDE report 11220031 ↗