ENROUTE Transcarotid Neuroprotection System FG12522Recalls & reported problems

Summary

The FDA's MAUDE database contains 688 adverse event reports that list this exact device (DI 00811311020829), received between Aug 30, 2017 and Apr 24, 2025 — classified as 4 deaths, 676 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Jul 9, 2026Class IOpen, Classified

   Potential for arterial sheath tip separation or partial tip separation during use.

   Z-2977-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 688 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHORTLY AFTER THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WOKE UP AND WAS UNABLE TO RAISE THEIR ARM ON COMMAND. IMAGING PERFORMED REVEALED AN EMBOLIC STROKE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT), HOWEVER, A P2Y12 PLATELET FUNCTION TEST WAS NOT PERFORMED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED, AND THE PATIENT HAS NOT MADE A COMPLETE RECOVERY. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS DUE TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION OR A SILK ROAD MEDICAL DEVICE, HENCE IT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 21903337 ↗
• InjuryApr 24, 2025Adverse 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 WAS SLOW TO WAKE UP AND EXPERIENCED LEFT SIDE WEAKNESS WITH FACIAL DROOP. IT WAS ALSO NOTED THAT THE PATIENT'S PULSE OXIMETER DROPPED ON RIGHT SIDE AND THE PATIENT ALSO EXPERIENCED BRADYCARDIA FOR A SHORT DURATION DURING THE PROCEDURE. THE PATIENT'S SYMPTOMS HAVE RESOLVED AND IS BACK TO BASELINE. ADDITIONAL INFORMATION INDICATED THAT THERE WAS SUSPICION OF PATIENT HAVING AN ISOLATED HEMISPHERE, BUT WAS NOT CONFIRMED AND THE ETIOLOGY OF THE STROKE IS UNKNOWN AT THIS TIME AT THIS TIME IT IS UNCLEAR IF THE REPORTED EVENT IS DUE TO PATIENT'S RESISTANCE TO MEDICATION, PROCEDURAL COMPLICATIONS OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 21900443 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, AN INTRAMURAL HEMATOMA OCCURRED, POSSIBLY WITH THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). THE PHYSICIAN PLACED AN UNPLANNED ADDITIONAL STENT TO ADDRESS THE HEMATOMA. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Hematoma

  MAUDE report 21780284 ↗
• InjuryApr 2, 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 FAILED THE POST PROCEDURE NEUROLOGICAL CHECK AND WAS UNABLE TO MOVE THEIR RIGHT HAND. THE PATIENT WAS ON PLAVIX AND ASPIRIN BUT NOT ON STATINS DUE TO STATIN ALLERGIES. ADDITIONAL INFORMATION STATED THAT EMBOLI WAS NOTED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), CONTRALATERAL TO THE TREATMENT SIDE. THE PHYSICIAN ELECTED TO PERFORM A THROMBECTOMY AND THE PATIENT HAS NOT RETURNED TO BASELINE. IT WAS DETERMINED BY THE PHYSICIAN THAT THE EVENT WAS DUE TO THE PATIENT'S UNDERLYING CONDITION OF ATRIAL FIBRILLATION. HOWEVER, THE SILK ROAD MEDICAL EXECUTIVE MEDICAL DIRECTOR REVIEWED THE MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2025 AND NOTED THAT NEW WHITE LESIONS WERE PRESENT IN THE CEREBELLUM, IN WATERSHED ZONES, AND THE LEFT MOTOR STRIP. THE CEREBELLUM IS SUPPLIED BY THE VERTEBROBASILAR ARTERIES WHICH ARE NOT INTERACTED WITH DURING THE TCAR PROCEDURE, HENCE THE EMBOLI IN THE CEREBELLUM ARE UNRELATED TO THE PROCEDURE. THE MOTOR STRIP IS SUPPLIED BY THE CAROTID ARTERIES, AND THE APPROXIMATE AGE OF THE LESIONS IN THE MOTOR STRIP INDICATED THAT THEY MAY BE RELATED TO THE TIMING OF THE TCAR

  Patient problems: Atrial Fibrillation; Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 21756795 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) CAUSED A DISSECTION. THE PHYSICIAN CONVERTED THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA) AND USED A GORE GRAFT TO REPAIR THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21703326 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EIGHT HOURS AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED WEAKNESS AND AN EMBOLIC STROKE. THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT) AND NO THROMBUS WAS NOTED. THE PATIENT HAS MADE A COMPLETE RECOVERY. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS DUE TO PROCEDURAL COMPLICATIONS, PATIENT'S RESISTANCE TO MEDICATION OR A SILK ROAD MEDICAL DEVICE, HENCE IT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 21643116 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS OBSERVED AFTER PLACEMENT OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). THE DISSECTION WAS REPAIRED WITH A SURGICAL PATCH AND THE PROCEDURE WAS COMPLETED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21563434 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WAS UNABLE TO SEE OUT OF HIS LEFT EYE PRIOR TO STENT PLACEMENT. THE PHYSICIAN DEPLOYED THE STENT AND COMPLETED THE PROCEDURE. ADDITIONAL INFORMATION STATED THAT THERE WAS NO THROMBUS NOTED, AND 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 TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Visual Disturbances

  MAUDE report 21562223 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, IT WAS IDENTIFIED THAT THE ARTERIAL SHEATH TIP OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS IN A DISSECTION PLANE. THE DISSECTION WAS TRAVERSED AND AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21516760 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS IDENTIFIED POST INSERTION OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). THE PHYSICIAN CONVERTED THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21435108 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS IDENTIFIED POST INSERTION OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21434887 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED WITH THE 0.035" J-TIP GUIDEWIRE OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21405127 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS IDENTIFIED AT THE INSERTION SITE OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21395533 ↗
• InjuryFeb 11, 2025Adverse 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 FAILED THE POST-PROCEDURE NEUROLOGICAL CHECK AND EXPERIENCED RIGHT ARM WEAKNESS AND SPEECH DIFFICULTIES. IMAGING REVELED NEW AREAS OF WATERSHED AND WAS SUSPECTED BY THE PHYSICIAN TO BE A WATERSHED EVENT. HOWEVER, A REVIEW OF THE IMAGING PROVIDED TO SILK ROAD MEDICAL'S EXECUTIVE MEDICAL DIRECTOR INDICATED THAT THERE WERE EMBOLI FOUND IN THE WATERSHED ZONE RESULTING IN A MIXED PATTERN EVENT. 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 FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

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

  MAUDE report 21355454 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED IN THE MID COMMON CAROTID ARTERY (CCA) WITH THE 0.035" J-TIP GUIDEWIRE OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) RESULTING IN DIFFICULTY ADVANCING THE 0.014" ENROUTE GUIDEWIRE INTO THE TARGET LESION. AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21276828 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED WITH THE 0.035" J-TIP GUIDEWIRE OR ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21276677 ↗
• InjuryJan 28, 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 FAILED THE POST-PROCEDURE NEUROLOGICAL CHECK AND EXPERIENCED RIGHT SIDED WEAKNESS AND APHASIA. IMAGING DID NOT REVEAL ANY ABNORMALITIES, AND THE STENT APPEARED PATENT. THE PATIENT WAS SWITCHED TO BRILINTA AND THE PATIENT'S SYMPTOMS HAVE IMPROVED BUT THEY HAVE NOT MADE A COMPLETE RECOVERY. ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN BELIEVED THE EVENT WAS EMBOLIC. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO THE PATIENT'S PRE-EXISTING CONDITION, PROCEDURAL COMPLICATIONS, PATIENT RESISTANCE TO MEDICATION OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

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

  MAUDE report 21252882 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED DURING THE INSERTION OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). THE PHYSICIAN CONVERTED THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21225559 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED DURING THE INSERTION OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21160709 ↗
• InjuryDec 6, 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 FAILED THE NEUROLOGICAL CHECK AND WAS UNABLE TO SQUEEZE THEIR RIGHT HAND. IMAGING REVEALED MULTIPLE NEW WHITE LESIONS IN THE LEFT HEMISPHERE. THE PATIENT'S SYMPTOMS HAVE NOT BEEN RESOLVED. THE ENROUTE NEUROPROTECTION SYSTEM (NPS) INSTRUCTIONS FOR USE (IFU) STATES THAT THE NPS IS CONTRAINDICATED IN PATIENTS WITH SEVERE DISEASE OF THE IPSILATERAL COMMON CAROTID ARTERY AS POTENTIAL EMBOLI COULD BE DISLODGED DURING INITIAL ACCESS AND POSITIONING OF A GUIDEWIRE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS DUE TO OFF LABEL USAGE, PATIENT RESISTANCE/ NON-COMPLIANCE TO MEDICATION OR A SILK ROAD MEDICAL DEVICE, HENCE WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 20872064 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED IN THE COMMON CAROTID ARTERY (CCA) WITH THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). THE PHYSICIAN REPAIRED THE DISSECTION WITH A PATCH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 20867971 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED IN THE COMMON CAROTID ARTERY WITH THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). THE PHYSICIAN CONVERTED TO TRANSFEMORAL CAROTID ARTERY STENTING (TF-CAS) AS A RESULT OF THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 20856160 ↗
• InjuryNov 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE 0.035" J-TIP GUIDEWIRE RETRACTED DURING INSERTION OF THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS), RESULTING IN A DISSECTION. THE PHYSICIAN CONVERTED THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 20800717 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE 0.035" J-TIP GUIDEWIRE OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) CAUSED A DISSECTION. THE PHYSICIAN CONVERTED THE PROCEDURE TO A TRANSFEMORAL CAROTID ARTERY STENTING (TF-CAS). THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 20797892 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION OCCURRED IN THE COMMON CAROTID ARTERY WITH THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 20797795 ↗