ENROUTE Transcarotid Stent SR-0740-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00811311020447), received between Sep 20, 2017 and Jun 18, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 other recall cover devices cleared under the same FDA submission (P140026); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMORRHAGIC STROKE FOLLOWING THE PROCEDURE, RESULTING IN ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT WAS SEEN BY NEUROSURGERY FOR A BRAIN BLEED/HEMATOMA. AN EMERGENCY CRANIOTOMY AND EVACUATION WERE PERFORMED. IT WAS NOTED THAT THE PATIENT APPEARED TO BE IMPROVING.

  Patient problems: Hematoma; Hemorrhagic Stroke

  MAUDE report 22285715 ↗
• InjuryMar 5, 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 LATER THE PATIENT EXPERIENCED HYPOTENSION WITH SYSTOLIC PRESSURES RANGING IN THE 70'S-60'S, BECAME INCOHERENT, AND WAS UNABLE TO FOLLOW COMMANDS. IMAGING REVEALED AN OCCLUDED STENT WITH THROMBUS. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND PERFORMED A CAROTID ARTERY ENDARTERECTOMY (CEA) WITH A PATCH ANGIOPLASTY. DURING STENT EXPLANT, THE PATIENT EXPERIENCED HYPERTENSION WITH SYSTOLIC PRESSURES RANGING IN THE 80S - 220S SYSTOLIC. AFTER THE STENT EXPLANT, THE PATIENT SUFFERED A HEMORRHAGIC STROKE. THE PATIENT IS CURRENTLY IN AN INDUCED COMA. THE HEMORRHAGIC STROKE WAS DETERMINED BY THE PHYSICIAN TO BE DUE TO THE PATIENT'S HIGH BLOOD PRESSURE AND NOT DUE TO THE TCAR PROCEDURE. ADDITIONAL INFORMATION STATED THAT THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK (TIA) ONE WEEK PRIOR TO THE TCAR PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT OF AN OCCLUDED STENT AND SUBSEQUENT STROKE IS DUE TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION OR A SILK ROAD MEDICAL DEVICE, HENCE IT WILL BE

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

  MAUDE report 21528472 ↗
• InjuryNov 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ONE DAY AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS AND FACIAL DROOP. BEFORE THE STROKE, THE PATIENT EXPERIENCED A BRIEF PERIOD OF HYPERTENSION OVER 200 SYSTOLIC FOR APPROXIMATELY FIVE MINUTES. IMAGING REVEALED A COMPRESSED STENT DUE TO THE CALCIFIED LESION. THE PATIENT'S SYMPTOMS HAD RESOLVED HOWEVER, THE PHYSICIAN ELECTED TO RELINE THE STENT WITH AN ADDITIONAL THIRD-PARTY STENT. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, THE PATIENT'S PRE-EXISTING CONDITION, PATIENT RESISTANCE/NON-COMPLIANCE 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; Muscle Weakness/Atrophy

  MAUDE report 20724072 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX DAYS AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT PRESENTED WITH APHASIA. IMAGING REVEALED RESIDUAL RESTENOSIS IN THE STENT. THE PATIENT'S SYMPTOMS HAVE COMPLETELY RESOLVED HOWEVER, IT IS UNKNOWN HOW LONG THE SYMPTOMS LASTED. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED DUE TO THE EVENT. AT THIS TIME, IT IS UNCLEAR IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE/NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Dysphasia; Restenosis; Stroke/CVA

  MAUDE report 19515223 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO WEEKS POST TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT PRESENTED WITH STROKE SYMTOMS, INCLUDING DIFFICULTY SPEAKING AND DROOLING AND HAD A RIGHT HEMISPHERIC STROKE. THE PHYSICIAN DETERMINED THAT THE STENT REQUIRED AN ANGIOPLASTY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT'S SYMPTOMS HAVE COMPLETELY RESOLVED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, 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; Restenosis

  MAUDE report 18052247 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE WEEKS AFTER A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT HAD A STROKE. IMAGING REVEALED THROMBUS WITHIN THE STENT. THE PHYSICIAN PERFORMED THROMBECTOMY TO ADDRESS THE ISSUE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO PROCEDURAL ISSUES, NON-COMPLIANCE TO MEDICATION, 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 17759865 ↗
• InjuryFeb 7, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A TCAR PROCEDURE, THE TIP OF THE STENT DELIVERY SYSTEM (SDS) WAS STUCK IN THE LESION WITHIN THE STENT. MULTIPLE MANIPULATIONS AND INTERVENTIONS WERE USED TO FREE THE TIP OF THE SDS AND THE PHYSICIAN CONVERTED TO A CAROTID ENDARTERECTOMY (CEA) PROCEDURE TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315125 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 7-8 DAYS AFTER THE COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE PERFORMED ON (B)(6) 2022, THE PATIENT EXHIBITED LIMB SHAKING TRANSIENT ISCHEMIC ATTACKS (TIA). MAGNETIC RESONANCE IMAGING (MRI) SHOWED INFARCTS ON THE LEFT SIDE, AND COMPUTED TOMOGRAPHY (CT) SHOWED THE ENROUTE STENT WAS OPEN BUT HAD NARROWED BY 80-90%. THE PHYSICIAN ELECTED TO REPEAT TCAR TO DILATE THE NARROWING WITH A 6MM BALLOON. THE PATIENT BECAME HYPOTENSIVE AFTER RECEIVING PROTAMINE, AND THE FOLLOWING DAY, THE PATIENT EXPERIENCED RIGHT HAND SHAKING, HEADACHES, AND NAUSEA. THE PHYSICIAN STATED THE PATIENT HAD A MAJOR STROKE. CT SHOWED THE STENT WAS OPEN, BUT THE PHYSICIAN ELECTED TO EXPLANT THE STENT VIA CAROTID ENDARTERECTOMY (CEA). MRI PERFORMED ON (B)(6) 2022 SHOWED TWO WHITE SPOTS ON THE LEFT FRONT PARIETAL LOBES. THE PATIENT WAS NOTED TO BE RECOVERING IN THE INTENSIVE CARE UNIT (ICU) AND WAS NOT ABLE TO USE HER RIGHT ARM AND WAS NOT ABLE TO SWALLOW. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT OF NEW WHITE LESIONS IS RELATED TO PROCEDURAL INTERVENTIONS (TCAR OR CEA), OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF

  Patient problems: Ischemia Stroke

  MAUDE report 15215064 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SUBSEQUENT TO A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE REP FOLLOWED UP WITH SITE AND IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGHT LOSS DUE TO A LACK OF BLOOD FLOW COMING FROM THE EXTERNAL CAROTID ARTERY (ECA). THE PATIENT HAD A CHRONICALLY OCCLUDED OPHTHALMIC ARTERY, WHICH WAS OCCLUDED EVEN FURTHER DUE TO PLAQUE SHIFT INTO THE ECA CAUSED BY ONE OF THE TWO STENTS USED IN THE PROCEDURE. AT THIS IS TIME, IT IS UNKNOWN WHICH STENT CAUSED THE PLAQUE SHIFT. IT WAS NOTED THAT THE PATIENT'S UNDERLYING CONDITION MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Loss of Vision; Stroke/CVA

  MAUDE report 12640553 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED SEVERE STENT COMPRESSION. THE PHYSICIAN ELECTED TO REMOVE THE STENT TO RESOLVE THE REPORTED ISSUE. THE LESION WAS CALCIFIED AND NO P2Y12 INHIBITOR TEST WAS PERFORMED ON THIS PATIENT. THE PATIENT WAS NEUROLOGICALLY INTACT AFTER THE PROCEDURE.

  Patient problems: Ischemia Stroke

  MAUDE report 12046236 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) YEAR OLD FEMALE UNDERWENT A RIGHT TRANSCAROTID REVASCULARIZATION PROCEDURE ON (B)(6) 2020. PATIENT HAS A HISTORY OF PRIOR CEA. PRE OP SCAN WAS PERFORMED WHICH APPEARED TO HAVE NONE TO MILD CALCIUM IN THE LESION. THERE WAS HOWEVER, VISIBLE DISEASE WITHIN THE CEA PATCHED AREA FROM THE INTERNAL CAROTID ARTERY ICA TO THE DISTAL COMMON CAROTID ARTERY (CCA). ALL TCAR INSTRUMENTS WERE PUT IN PLACE WITHOUT INCIDENCE. PHYSICIAN PRE DILATED BALLOON. THE PHYSICIAN DEPLOYED A 0740 STENT WITHOUT COMPLICATION, UNDER PROPER FLOW REVERSAL. IMPLANT APPEARED TO HAVE NO RESIDUAL STENOSIS POST ANGIOGRAM. HOWEVER, POST OP CT SCAN SHOWED THAT THE STENT WAS COMPRESSED TO THE POINT WHERE THE PHYSICIAN EXPLANTED THE DAY AFTER IMPLANT. PATIENT IS STABLE POST EXPLANT. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9751315 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BASELINED AT THE END OF THE PROCEDURE ON 17JUL2019. THE PHYSICIAN INFORMED A SILK ROAD MEDICAL PRINCIPAL THERAPY DEVELOPMENT SPECIALIST, THAT THE PATIENT SUFFERED A STROKE OVERNIGHT. THE PATIENT WAS SENT TO ALLEGHENY GENERAL HEALTH FOR NEURO RESCUE, AS BOTH STENTS HAD THROMBOSED. IT WAS ALSO OBSERVED THAT THERE WAS A SMALL DISSECTION AT THE SHEATH TIP DURING THE PROCEDURE. HOWEVER, THE PHYSICIAN INDICATED THAT IT DID NOT NEED TO BE TREATED. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 8903577 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACUTE STENT OCCLUSION POST LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR). PATIENT REQUIRED SURGICAL RE-INTERVENTION (THROMBECTOMY) AFTER PATIENT UNABLE TO DEMONSTRATE MOVEMENT OF R-ARM AND R-LEG UPON AWAKENING. PATIENT SENT FOR FOLLOW-UP CTA IMMEDIATELY POST-SURGICAL RE-INTERVENTION.

  Patient problems: Thrombosis

  MAUDE report 6881498 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140026. One submission often covers many models, so check the product and lot details in each record.

• Z-1146-2021 · Jan 13, 2021 · Terminated
  ENROUTE Transcarotid Stent System REF SR-XXYY-CS