ENROUTE Transcarotid Stent SR-0930-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00811311020492), received between Aug 26, 2020 and Sep 24, 2026 — classified as 1 death, 16 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891902 ↗
• 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 25365598 ↗
• MalfunctionApr 13, 2026Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT THE DEVICE ENCOUNTERED RESISTANCE UPON ADVANCEMENT AND DIFFICULTY DURING REMOVAL. THE PATIENT PRESENTED AS ASYMPTOMATIC FOR A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE TREATED VESSEL EXHIBITED SEVERE CALCIFICATION, AND VESSEL TORTUOSITY WAS DESCRIBED AS MILD. THE TARGET LESION DEMONSTRATED APPROXIMATELY 90% STENOSIS. THE ENROUTE TRANSCAROTID STENT SYSTEM (TSS) WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE DELIVERY SYSTEM INTO THE SHEATH AND, AS IT EXITED THE SHEATH TIP, FELT RESISTANCE. THE PHYSICIAN REPORTED THAT REMOVAL DIFFICULTY WAS NOT RELATED TO VESSEL ANATOMY OR LESION CHARACTERISTICS. FLUOROSCOPY CONFIRMED THAT THE STENT HAD NOT DEPLOYED. THE PHYSICIAN APPLIED ADDITIONAL FORCE BUT WAS UNABLE TO ADVANCE THE DELIVERY SYSTEM AND SUBSEQUENTLY ATTEMPTED TO WITHDRAW IT, AT WHICH POINT THE DELIVERY SYSTEM WAS NOTED TO BE STUCK ON THE WIRE. THE DELIVERY SYSTEM AND GUIDEWIRE WERE REMOVED TOGETHER AS A UNIT, AFTER WHICH THE PHYSICIAN REMOVED THE DELIVERY SYSTEM FROM THE GUIDEWIRE OUTSIDE THE BODY USING HEMOSTATS AND FORCE. THE PHYSICIAN EXCHANGED THE DEVICE AND SUCCESSFULLY ADVANCED AND DEPLOYED A STENT IN THE INTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859472 ↗
• InjuryAug 26, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE STENT WOULD NOT EXPAND POST DEPLOYMENT. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE STENT WOULD NOT EXPAND POST DEPLOYMENT. POST-DILATION WAS ATTEMPTED AND DID NOT RESOLVE THE ISSUE. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893819 ↗
• InjuryMay 23, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE STENT DID NOT FULLY EXPAND WITHIN THE LUMEN, RESULTING IN ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE. THE PATIENT PRESENTED AS SYMPTOMATIC AND HAD SEVERE TORTUOSITY IN THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE PATIENT UNDERWENT A SUCCESSFUL TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. HOWEVER, THERE WERE SOME STENT PLACEMENT DIFFICULTIES, WHEN THE PATIENT WOBBLED DURING THE PROCEDURE. THE BLOOD PRESSURE OF THE PATIENT WAS ALSO VERY LOW. POST PROCEDURE THE PATIENT AWOKE FINE. HOURS LATER, IT WAS REPORTED THAT THE PATIENT HAD RIGHT SIDED WEAKNESS, HYPOTENSION, AND WAS EXPERIENCING A POSSIBLE TRANS ISCHEMIC ATTACK (TIA). IT WAS SUSPECTED THAT THE ENROUTE 0.014 GUIDEWIRE HAD GONE SUB-PLAQUE IN THE COMMON CAROTID ARTERY (CCA) AND THEN BACK INTO THE TRUE LUMEN. EVEN THOUGH THE GUIDEWIRE DID NOT BEHAVE IN AN ODD FASHION TO INDICATE A DISSECTION. THE PHYSICIAN ELECTED TO PERFORM A REPEAT CT WHICH REVEALED NO SIGNS OF STROKE, BUT DID REVEAL THAT THE PROXIMAL PORTION OF THE STENT APPEARED COMPRESSED, BECAUSE THE STENT WAS PLACED PARTIALLY IN THE ATHEROMA. THE DISTAL PORTION OF THE STENT WAS OPEN. LATER THAT DAY, THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079507 ↗
• MalfunctionFeb 19, 2025Difficult to Remove; Material Deformation; Material Split, Cut or Torn; Difficult to Remove; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, UPON DEPLOYMENT OF THE ENROUTE TRANSCAROTID STENT SYSTEM (TSS), THE STENT DELIVERY SYSTEM (SDS) COULD NOT BE REMOVED AND WAS STUCK WITHIN THE STENT. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SDS AND RECAPTURE THE NOSECONE, ATTEMPTED TO ADVANCE A BUDDY WIRE, AND ATTEMPTED GENTLE MANIPULATION OUTSIDE OF THE SKIN TO FACILITATE REMOVING THE SDS WITHOUT SUCCESS. THE PHYSICIAN ELECTED TO PERFORM A LARGER CUT DOWN AND APPLIED DIRECT MANIPULATION TO THE OUTSIDE OF THE CAROTID ARTERY AND SUCCESSFULLY REMOVED THE SDS FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414592 ↗
• InjuryJun 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, 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 19639015 ↗
• InjuryJun 21, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT DID NOT WAKE UP FROM ANESTHESIA. IMAGING REVEALED THROMBOSIS IN THE MIDDLE OF THE STENT, AND STENT COMPRESSION. FURTHER INTERNAL IMAGE REVIEW INDICATED OCCLUSION IN THE RIGHT INTERNAL CAROTID ARTERY (RICA), POSTERIOR WALL COMPRESSION BY EXTERNAL CALCIUM AND EXTENSIVE MURAL THROMBUS AT THE ARCH. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND PERFORM CAROTID ENDARTERECTOMY (CEA) PROCEDURE. ADDITIONALLY, THE STENT WAS 62% NARROWED BY NORTH AMERICAN SYMPTOMATIC CAROTID ENDARTERECTOMY TRIAL (NASCET) CRITERIA. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND PERFORM CAROTID ENDARTERECTOMY (CEA) PROCEDURE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENTS ARE RELATED TO PROCEDURAL COMPLICATIONS, 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; Loss of consciousness; Stenosis; Thrombosis/Thrombus

  MAUDE report 19589710 ↗
• InjuryMay 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT TWO DAYS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A MINOR STROKE. THE PHYSICIAN REPORTED THAT THE STENT HAD APPEARED RECOILED AS THE STENT WAS CONSTRICTED WITH A NARROWED LUMEN IN THE AREA WHERE CALCIUM WAS PRESENT AND THROMBUS WAS IDENTIFIED. THE PATIENT WAS ADMINISTERED HEPARIN, AND NO ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT'S SYMPTOMS HAVE RESOLVED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED FAILURE 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: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 19226842 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED ALTERED MENTAL STATUS, AND IMAGING REVELED THROMBUS IN THE COMMON CAROTID ARTERY (CCA) AND INTERNAL CAROTID ARTERY (ICA) EXTENDING TO SKULL BASE. BOTH STENTS WERE EXPLANTED, AND THE CCA/ICA WERE ENDARTERECTOMIZED. IT WAS ALSO NOTED THAT DURING CLOSING, THE PATIENT'S BLOOD PRESSURE WAS 70-90MMHG AND DID NOT RISE ABOVE 90 MMHG UNTIL LEAVING THE OPERATING ROOM (OR). HYPOTENSION CAN INCREASE THE RISK OF PERIPROCEDURAL THROMBUS FORMATION, AND IT WAS ALSO REPORTED THE PATIENT HAD A HIGHLY CALCIFIED LESION THAT IMPINGED THE STENT AT THE LESION. THE INFORMATION PROVIDED INDICATES THAT THE EVENTS WERE LIKELY RELATED TO BLOOD PRESSURE MISMANAGEMENT AND THE ANATOMICAL/UNDERLYING CONDITION OF THE PATIENT AND NOT A SILK ROAD MEDICAL DEVICE FAILURE. HOWEVER, WE ARE UNABLE TO ELIMINATE THE STENT AS A POTENTIAL CONTRIBUTING FACTOR TO THE THROMBOSIS FORMATION AS THE PHYSICIAN TOOK ACTION TO REMOVE THE STENT AS PART OF THE ACTION TO PREVENT PERMANENT IMPAIRMENT.

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

  MAUDE report 18909417 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HOURS AFTER A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT'S STENT HAD THROMBOSED AND HE EXPERIENCED VISUAL DEFICITS. THE PHYSICIAN TREATED MEDICALLY, AND THE PATIENT'S SYMPTOMS RESOLVED WITHIN 36 HOURS. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, MEDICATION NON-COMPLIANCE OR RESISTANCE, 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 18307159 ↗
• InjuryNov 9, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT 16 DAYS AFTER THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED DIZZINESS UPON STANDING. IMAGING INDICATED THAT THE STENTS EXTENDING FROM DISTAL COMMON CAROTID ARTERY (CCA) TO THE INTERNAL CAROTID ARTERY (ICA) WERE COMPRESSED DUE TO CALCIFICATION, RESULTING IN 80% STENOSIS. THE PHYSICIAN PERFORMED A CAROTID ENDARTERECTOMY (CEA) AND EXPLANTED THE STENTS. 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 PATIENT CONDITION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Dizziness; Stenosis

  MAUDE report 18107900 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT HAD A STROKE. IMAGING REVEALED A THROMBOSED STENT. THE PHYSICIAN EXPLANTED THE STENT TO ADDRESS THE ISSUE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED FAILURE 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: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 17484754 ↗
• InjuryJun 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED VISUAL CHANGES. THE STENT WAS IDENTIFIED TO HAVE BEEN PLACED SUBINTIMALLY. THE STENT WAS SURGICALLY EXPLANTED, AND THE PATIENT RETURNED TO BASELINE.

  Patient problems: Vascular Dissection

  MAUDE report 17131695 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO UPDATE SECTION B5 AND B7 PER INTERNAL REVIEW: IT WAS REPORTED THAT POST-BYPASS GRAFT SURGERY, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE AND EXPIRED. THE BYPASS GRAFT WAS TO REDIRECT FLOW AROUND THE STENT AND WAS A HIGHLY INVASIVE PROCEDURE, HENCE THE POST-BYPASS STROKE AND DEATH WERE NOT ATTRIBUTED TO THE ENROUTE TRANSCAROTID STENT.

  Patient problems: Ischemia Stroke

  MAUDE report 16753956 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT HAD SOME HYPOTENSION AND BECAME APHASIC. THE BLOOD PRESSURE WAS INCREASED, AND THE APHASIA RESOLVED. HOWEVER, THE FOLLOWING MORNING, THE PATIENT AGAIN DISPLAYED APHASIA AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) INDICATED COMPRESSION OF THE CAROTID STENT. MAGNETIC RESONANCE IMAGING (MRI) REVEALED BILATERAL NEW WHITE LESIONS. THE PHYSICIAN PERFORMED ANOTHER TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE TO BALLOON THE PRIOR PLACED STENT. AS THE MAGNETIC RESONANCE IMAGING (MRI) RESULTS ARE NOT CONSISTENT WITH LEFT CAROTID TREATMENT (NEW LESIONS ON BOTH HEMISPHERES VS. NEW LESIONS ON THE LEFT HEMISPHERE) IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO A PATIENT MEDICAL CONDITION, OR A SILK ROAD MEDICAL DEVICE FAILURE SILK ROAD MEDICAL WILL REPORT THE EVENT OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke

  MAUDE report 16708017 ↗
• DeathJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS AFTER COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT'S STENT THROMBOSED. A STROKE OCCURRED, AND THE PATIENT WAS PARALYZED ON THE RIGHT LEG AND ARM. THE PHYSICIAN PERFORMED A THROMBECTOMY AND BALLOON ANGIOPLASTY AND PLACED THE PATIENT ON TICAGRELOR/BRILINTA. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 INDICATED THAT PATIENT WAS IN THE HOSPITAL FOR 30 DAYS AND THEN WAS DISCHARGED. THE PATIENT WENT TO A REHABILITATION FACILITY AND SUBSEQUENTLY PASSED AWAY. THE CAUSE AND DATE OF DEATH ARE UNKNOWN. AT THIS TIME, THERE IS NO INDICATIONS AS TO WHAT MAY HAVE CAUSED THE THROMBUS, OR IF THE REPORTED FAILURE IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO DUAL ANTIPLATELET THERAPY (DAPT) 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 14593468 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE COMPLETION OF A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED STROKE LIKE SYMPTOMS THAT INCLUDED LEFT SIDE WEAKNESS LASTING LONGER THAN 24 HOURS. A CTA WAS PERFORMED SHOWING ACUTE STENT THROMBOSIS. NO P2Y12 INHIBITOR TEST WAS PERFORMED ON THE PATIENT PRIOR TO THE TCAR PROCEDURE. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION, AS IT IS UNCLEAR IF THE ADVERSE EVENT WAS CAUSED BY THE PROCEDURE, PATIENT RESPONSE OR THE MANUFACTURER'S DEVICE.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 12181677 ↗
• InjuryFeb 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, AFTER STENT DEPLOYMENT, THE DISTAL TIP (NOSECONE) WAS DETACHED FROM THE STENT DEPLOYMENT SYSTEM (SDS). A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE TIP FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355313 ↗
• MalfunctionOct 13, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A TRANS-CAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE STENT WOULD NOT PASS THROUGH THE LESION. WHILE PULLING THE STENT BACK, THE DISTAL TIP OF THE STENT DELIVERY SYSTEM CAME OFF, AND REMAINED IN THE CAROTID ARTERY. THE PHYSICIAN MADE THE DECISION TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA), AND SUCCESSFULLY REMOVED THE MARKER, AND THE CAROTID WAS FIXED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10674067 ↗
• InjuryAug 26, 2020Collapse; Collapse

  A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE WAS COMPLETED SUCCESSFULLY ON (B)(6) 2020. THE PATIENT RETURNED ON JULY 29, 2020 FOR A STENT THAT WAS SEVERELY COMPRESSED AND NEAR OCCLUSIVE. REPORTEDLY SINGLE PLANE FULL COMPRESSION ON CT SCAN WITH INTRALUMINAL THROMBUS AND DISEASE DISTAL TO STENT THAT CAN BE TREATED VIA CAROTID ENDARTERECTOMY (CEA). THE PATIENT SOUGHT A DIFFERENT SURGEON, WAS SEEN AS AN OUTPATIENT IN THE OFFICE WITH UPCOMING EXPLANT SCHEDULED, AND IS REPORTEDLY HEALTHY WITH NO CURRENT STROKE SYMPTOMS. THE CALCIUM BURDEN WAS NOT PROHIBITIVE PRIOR TO THE CASE. THE PHYSICIAN ALSO USED A 5X20 BALLOON FOR PRE-DILATATION AND NO POST-DILATATION WAS DONE.

  Patient problems: Occlusion

  MAUDE report 10455611 ↗