ENROUTE Transcarotid Stent SR-0840-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00811311020478), received between Nov 30, 2016 and Aug 3, 2026 — classified as 2 deaths, 56 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• DeathAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a stroke and the patient passed away.An ENROUTE Transcarotid Stent was selected for use in a right sided Transcarotid Artery Revascularization (TCAR) procedure. After the TCAR procedure, the patient experienced a hemorrhage stroke with left sided deficit after extiubation. The physician reported that the patient did not have high-risk features for cerebral hyperperfusion syndrome. It was further reported that the patient passed away.

  Patient problems: Cerebral Hyperperfusion Syndrome; Hemorrhagic Stroke; Muscle Weakness/Atrophy

  MAUDE report 50124309 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced stent thrombosis and stroke post procedure.An ENROUTE Transcarotid Stent was selected for use in a left side Transcarotid Artery Revascularization (TCAR) procedure. During the procedure, plaque prolapse was noted within the stent and a second stent was placed to reline the vessel. The procedure was completed with no notable issues. Six days post procedure, the patient returned with right side numbness. The patient was admitted and administrated with heparin drip. Imaging performed revealed stent thrombosis and an embolic stroke. There was no P2y12 test performed but the patient was switched from Plavix to Brilinta and Eliquis. Additionally, it was reported that the patient had an intraluminal filling defect noted prior to the TCAR procedure.

  Patient problems: Ischemia Stroke; Numbness; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 25449544 ↗
• InjuryMay 26, 2026Use of Device Problem

  It was reported that the stent was inadvertently deployed in the right carotid artery instead of the left carotid artery, requiring additional surgical intervention.An ENROUTE Transcarotid Stent was selected for use in a left side Transcarotid Artery Revascularization (TCAR) procedure. Procedure was completed successfully with no complications. At the one month follow up visit, the physician noted that the stent had been inadvertently deployed in the right carotid artery instead of the left carotid artery. The physician explained that the incision was made using on table duplex ultrasound guidance and believes the location was closer to the sternal notch and the patients right subclavian passed over it. The physician performed another TCAR to treat the left side and the procedure was completed successfully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283904 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT VESSEL WAS OCCLUDED REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. POST PROCEDURE, THE PATIENT EXPERIENCED RIGHT ARM WEAKNESS WHICH THE PHYSICIAN ATTRIBUTED TO A PREVIOUS RIGHT SIDED STROKE. IMAGING PERFORMED REVEALED NO NEW WHITE LESIONS, BUT DID REVEAL SOME CONTAINED LOW-DENSITY MATERIAL, CONSISTENT WITH POSSIBLE PLAQUE PROLAPSE AND POSSIBLE THROMBUS. THE STENT WAS EXPLANTED AND AN ENDARTERECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME DESPITE REQUEST BY BOSTON SCIENTIFIC (BSC).

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 25233465 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A STROKE AND THROMBUS WAS IDENTIFIED WITHIN THE STENT. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO APPARENT ISSUES, AND THE PATIENT PASSED THE POST PROCEDURE NEUROLOGICAL CHECK. APPROXIMATELY 18 DAYS POST PROCEDURE, THE PATIENT EXPERIENCED A STROKE WITH THE INABILITY TO MOVE THEIR RIGHT EXTREMITY AND WAS READMITTED TO THE HOSPITAL. IMAGING REVEALED THROMBUS WITHIN THE STENT. THE PATIENT WAS TAKING PLAVIX BUT WAS SWITCHED TO BRILINITA. NO INTERVENTION WAS PERFORMED AS A RESULT OF THE EVENT.

  Patient problems: Paralysis; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 24967582 ↗
• InjuryFeb 4, 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 LEFT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. THE PATIENT WAS ON PLAVIX FOR TWO MONTHS AND IMAGING SHOWED A PATENT STENT. ONE YEAR AFTER THE TCAR PROCEDURE, THE PATIENT PRESENTED WITH SYMPTOMS AND WAS ADMITTED. IMAGING REVEALED STENT THROMBOSIS AND OCCLUSION. FURTHER IMAGING REVIEW REVEALED THAT THERE WAS LOW-DENSITY MATERIAL INSIDE THE STENT THAT WAS CONSISTENT WITH NEOINTIMAL HYPERPLASIA (NIH). THE STENT WAS EXPLANTED, AND THE CAROTID WAS PATCHED. THE PHYSICIAN NOTED SUBSTANTIAL INFLAMMATION OF THE PERIVASCULAR TISSUES AT THE TIME OF DEVICE EXPLANT, WHICH CAN BE SEEN IN PATIENTS WITH A NICKEL ALLERGY, THOUGH THIS ALLERGY WAS NOT CONFIRMED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK (TIA), BUT THE RESOLUTION OF SYMPTOMS WAS NOT CONFIRMED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 24262113 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IN-STENT THROMBOSIS, LEADING TO DEVICE EXPLANT. THE PATIENT PRESENTED WITH SYMPTOMS. AN ENROUTE TRANSCAROTID STENT SYSTEM WAS SELECTED FOR A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. APPROXIMATELY 26 HOURS POST-PROCEDURE, THE PATIENT EXPERIENCED A TIA, WITH SYMPTOMS MANIFESTING ON THE LEFT SIDE. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED A FILLING DEFECT, INDICATING THE PRESENCE OF THROMBUS AND PLAQUE PROLAPSE MATERIAL WITHIN THE STENT LUMEN. ALTHOUGH THE PATIENT HAD PASSED THE POST-PROCEDURE NEUROLOGICAL CHECK, POSTOPERATIVE BLOOD PRESSURE EXCEEDED 230 MMHG. COMPLIANCE WITH DUAL ANTIPLATELET THERAPY (DAPT) WAS CONFIRMED; HOWEVER, NO P2Y12 INHIBITOR TEST HAD BEEN PERFORMED. THE STENT WAS SUBSEQUENTLY EXPLANTED. IMAGES OF THE EXPLANTED STENT DEMONSTRATED PLAQUE PROLAPSE AND PLATELET AGGREGATES WITHIN THE STENT. THE PATIENT WAS REPORTEDLY DOING WELL.

  Patient problems: High Blood Pressure/ Hypertension; Obstruction/Occlusion; Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 23414453 ↗
• InjuryOct 23, 2025Positioning Problem; Positioning 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. DURING THE TCAR PROCEDURE, THE PHYSICIAN HAD INADVERTENTLY PLACED THE STENT IN A DISSECTION PLANE THAT WAS CAUSED BY A NON-BOSTON SCIENTIFIC WIRE. SIX HOURS POST PROCEDURE, THE PATIENT EXPERIENCED AN EMBOLIC STROKE. POST PROCEDURE IMAGING REVEALED THAT THE LEFT OPHTHALMIC ARTERY WAS OCCLUDED. NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC. IT WAS FURTHER REPORTED THAT NO INTERVENTION WAS PERFORMED.

  Patient problems: Embolism/Embolus; Ischemia Stroke

  MAUDE report 23372793 ↗
• InjuryOct 15, 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 POST PROCEDURE REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST PROCEDURE, THE PATIENT FAILED TO MOVE RIGHT UPPER EXTREMITIES AND EXPERIENCED FACIAL DROOP. IMAGING PERFORMED REVEALED A THROMBOTIC STROKE. THE PHYSICIAN PERFORMED A THROMBOTIC ASPIRATION AND ADMINISTRATED THE PATIENT WITH CANGRELOR.

  Patient problems: Facial Paralysis; Ischemia Stroke; Paralysis; Thrombosis/Thrombus

  MAUDE report 23303667 ↗
• MalfunctionOct 15, 2025Break; Positioning Failure; Difficult to Remove; Activation Failure; Break; Positioning Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM. THE PATIENT PRESENTED AS SYMPTOMATIC. AN ENROUTE TRANSCAROTID STENT SYSTEM WAS SELECTED FOR USE FOR A RIGHT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AS THE SURGEON UNKNOWINGLY PINNED THE CATHETER NEAR THE SHEATH HUB. AFTER REPOSITIONING THE DELIVERY SYSTEM, THE INTERVENTIONAL CARDIOLOGIST ATTEMPTED DEPLOYMENT BUT MISTAKENLY PUSHED THE HYPOTUBE FORWARD INSTEAD OF USING THE PIN-AND-PULL TECHNIQUE, RESULTING IN A BROKEN HYPOTUBE AND FAILED STENT DEPLOYMENT. THE PHYSICIAN PROCTOR THEN RECOMMENDED REMOVING THE DELIVERY SYSTEM. RESISTANCE WAS FELT DURING REMOVAL OVER THE GUIDEWIRE, BUT THE DELIVERY SYSTEM WAS ULTIMATELY REMOVED AND FOUND TO BE DAMAGED. THE DEVICE WAS EXCHANGED, AND A NEW STENT WAS SUCCESSFULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301823 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED, WHICH WAS TREATED USING AN ADDITIONAL STENT. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE 8MM X 40MM WAS ADVANCED, AND THEN A TCAR TIMEOUT WAS PERFORMED TO TAKE SOME IMAGES. THE SURGEON SUSPECTED THERE WAS A SMALL DISSECTION, AND ELECTED TO PLACE AN ADDITIONAL ENROUTE STENT, 7MM X 30MM, DISTALLY TO THE 8MM X 40MM, OVERLAPPING. FURTHER IMAGING WAS REVIEWED, AND THE SURGEON WAS SATISFIED WITH THE STENT PLACEMENT. THE TCAR PROCEDURE WAS COMPLETED, AND THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 22290505 ↗
• InjuryJun 6, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS INADVERTENTLY DEPLOYED IN THE EXTERNAL CAROTID, REQUIRING ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE SURGEON ACCESSED THE VESSEL, AND THE LESION WAS PREDILATED. THE STENT WAS DEPLOYED. AT THIS POINT, IT WAS OBSERVED THAT THE STENT WAS INADVERTENTLY DEPLOYED IN THE LEFT EXTERNAL CAROTID RATHER THAN THE LEFT INTERNAL CAROTID. THE LEFT EXTERNAL CAROTID RAN ALONGSIDE THE LEFT INTERNAL CAROTID AND BOTH TOOK THE SAME BEND. AS A RESULT, THE EXTERNAL CAROTID WAS OPENED AND THE STENT WAS REMOVED. THE PROCEDURE WAS CONVERTED TO A CAROTID ENDARTERECTOMY (CEA). THE PATIENT WAS REPORTED AS STABLE AND DID WELL POST-PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159157 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT OCCLUDED POST TCAR, RESULTING IN HOSPITALIZATION, AND ADDITIONAL INTERVENTION. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2025 WITH RIGHT SIDE WEAKNESS AND FACIAL DROOP. THE PATIENT WAS ADMITTED AND HAD A MASSIVE WATERSHED STROKE THAT NIGHT. ANEMIC TO 6, MASSIVE STROKE, NIH SCORE 15. THE SURGEON WAITED OVER A WEEK TO DO PERFORM A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE DUE TO THE PATIENT SPIKING A FEVER AND UNCONTROLLED SYSTOLIC PRESSURE. SYSTOLIC PRESSURE WENT AS HIGH AS 250 SYSTOLIC WHEN NOT ON PROPER MEDICATIONS TO CONTROL. ON (B)(6) 2025, SYSTOLIC WAS CONTROLLED, BUT IT WAS DIFFICULT FOR ANESTHESIA TO GET THE PRESSURE WITHIN THE 140-160 TARGET AND REQUIRED LOTS OF MEDICATION. THE PATIENT HAD OVER 70% STENOSIS ON BOTH CAROTIDS. ACT WAS OVER 250. THE TCAR PROCEDURE WAS COMPLETED WITH GOOD RESULTS, AND THE STENT WAS PATENT. THE PHYSICIAN HELPED FROM THE PHONE DURING THE CASE AND SUGGESTED KEEPING SYSTOLIC PRESSURE 100-140 POST-PROCEDURE. FOUR HOURS POST PROCEDURE, THE STENT OCCLUDED. PLAVIX RESISTANCE TEST WAS CONDUCTED, AND THE PATIENT WAS NORMAL. THE PHYSICIAN SUSPECTED THE OCCLUSION COULD BE FROM HYPOTENSION, BECAUSE

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 22155640 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MYOCARDIAL INFARCTION OCCURRED. AN ENROUTE TRANSCAROTID STENT WAS IMPLANTED IN AN ASYMPTOMATIC PATIENT, DURING A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. SOMETIME LATER, THE PATIENT SUFFERED FROM A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION WAS AVAILABLE TO BOSTON SCIENTIFIC. IT WAS FURTHER REPORTED THAT THE STUDY SUBJECT DID NOT, IN FACT, EXPERIENCE A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079835 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WATERSHED STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT SUFFERED FROM HYPERTENSION. DURING THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE WAS LABILE AND HIGH (203/70). POST PROCEDURE, THE PATIENT WAS HYPERTENSIVE. THE PATIENT WAS DISCHARGED THE NEXT DAY AND CAME BACK THE FOLLOWING DAY WITH DYSARTHRIA. A COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) WAS PERFORMED, AND IT WAS CLEAN. THE PATIENT COMPLAINED OF A MASSIVE HEADACHE. AN MRI WAS PERFORMED WHICH REVEALED WATERSHED INFARCTS AND SMALL PETECHIAL HEMORRHAGE. THE PATIENT WAS STABLE AND RESPONSIVE. THE PATIENT'S SYMPTOMS RESOLVED WITHIN A FEW DAYS, AND THEY WERE DISCHARGED ON MEDICAL MANAGEMENT.

  Patient problems: Dysphasia; High Blood Pressure/ Hypertension; Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 22035283 ↗
• InjuryMar 19, 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 CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND AFTER THE PATIENT WAS STABILIZED, THEY EXPERIENCED HYPOTENSION AND THE PATIENT'S EJECTION FRACTION (EF) WAS 5 PERCENT. IMAGING REVEALED A SMALL THROMBUS IN THE STENT. THE PHYSICIAN ELECTED TO RE-LINE THE STENT WITH A THIRD PARTY STENT (GORE VIABAHN). ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT) AND IT IS UNKNOWN IF A P2Y12 PLATELET FUNCTION TEST WAS PERFORMED. THERE WERE NO DISSECTIONS OR OTHER PROCEDURAL ISSUES REPORTED AND THE PATIENT DID NOT EXPERIENCE ANY STROKE SYMPTOMS. THE REPORTED EVENT OF CARDIAC ARREST IS RELATED TO THE PATIENT'S UNDERLYING CONDITION, AND NOT RELATED TO A SILK ROAD MEDICAL DEVICE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED THROMBUS EVENT WAS DUE TO THE PATIENT'S UNDERLYING CONDITION, PATIENT RESISTANCE TO MEDICATION OR A SILK ROAD MEDICAL DEVICE, HENCE IT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

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

  MAUDE report 21649025 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO WEEKS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A STROKE AND IMAGING REVEALED THROMBUS WITHIN THE STENT. A P2Y12 RESISTANCE TEST REVEALED THE PATIENT WAS THERAPEUTIC. NO INTERVENTION WAS PERFORMED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, MEDICATION NON-COMPLIANCE OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 21646875 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WAS FOUND UNRESPONSIVE AT THEIR HOME. IMAGING REVEALED BILATERAL MULTIFOCAL LESIONS AND A PATENT STENT. THE PATIENT HAS NOT MADE A COMPLETE RECOVERY. 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; Loss of consciousness

  MAUDE report 20919462 ↗
• InjurySep 4, 2024Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED RIGHT ARM WEAKNESS. THE PHYSICIAN IDENTIFIED VIA IMAGING THAT THE STENT WAS COMPRESSED AS IT WAS DEPLOYED IN A DISSECTION PLANE. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND THE PATIENT'S SYMPTOMS RESOLVED.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 20137837 ↗
• InjurySep 4, 2024Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED RIGHT ARM WEAKNESS. THE PHYSICIAN IDENTIFIED VIA IMAGING THAT THE STENT WAS COMPRESSED AS IT WAS DEPLOYED IN A DISSECTION PLANE. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND THE PATIENT'S SYMPTOMS RESOLVED.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 20137804 ↗
• InjuryAug 6, 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 RIGHT SIDED WEAKNESS. IMAGING REVEALED AN OCCLUDED STENT THROMBOSED FROM MID PORTION TO THE TERMINAL LEFT INTERNAL CAROTID ARTERY (LICA) AND NO FLOW IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) BEYOND THE STENT. PRE-PROCEDURE, THE PATIENT HAD A VERY TIGHT LESION. THE PHYSICIAN DID NOT PERFORM ADDITIONAL INTERVENTION AND, AS OF TWO DAYS POST-PROCEDURE, THE PATIENT'S STROKE SYMPTOMS HAD ALMOST COMPLETELY RESOLVED. ADDITIONALLY, PLATELET REACTIVITY TEST PERFORMED SEVEN DAYS PRIOR TO THE TCAR PROCEDURE INDICATED PLATELET INHIBITION. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT ANATOMY OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 19921573 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 6 DAYS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE THE PATIENT PRESENTED WITH STROKE LIKE SYMPTOMS. IMAGING REVEALED FILLING DEFECT/THROMBUS WITHIN THE STENT. IT WAS NOTED THAT THE LESION WAS NOT FULLY COVERED BY THE STENT. THE PHYSICIAN PERFORMED CLOT ASPIRATION AND RELINED THE ARTERY WITH AN ADDITIONAL STENT. THE PATIENT'S SYMPTOMS HAVE NOT YET 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, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 19397459 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  18 MONTHS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT CONTACTED SILK ROAD MEDICAL AND STATED THEY WERE ALLERGIC TO NICKEL AND REQUESTED A STENT EXPLANTATION. THE STENT WAS EXPLANTED ON (B)(6) 2023. SILK ROAD MEDICAL HAS NOT RECEIVED EVIDENCE OF THE PATIENT'S NICKEL ALLERGY. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO A SILK ROAD MEDICAL DEVICE. HOWEVER, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18188555 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HOURS AFTER THE SUCCESSFUL COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED STROKE SYMPTOMS AND THE STENT HAD OCCLUDED. THE PHYSICIAN RE-BALLOONED THE STENT AND PERFORMED A MECHANICAL THROMBECTOMY. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S SYMPTOMS WERE RESOLVING. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO MEDICATION/PATIENT RESPONSE (PLAVIX RESISTANCE), A PROCEDURAL ISSUE, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18136736 ↗
• 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 18107887 ↗

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