ENROUTE Transcarotid Stent SR-0830-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00811311020461), received between Aug 16, 2018 and Jun 9, 2026 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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; Thrombosis/Thrombus

  MAUDE report 25449518 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED STROKE POST PROCEDURE;AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DUE TO THE SOFT CHARACTERISTICS OF THE PATIENTS PLAQUE, A SECOND STENT WAS PLACED. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. NEXT MORNING, THE PATIENT EXPERIENCED RIGHT ARM WEAKNESS AND APHASIA. IMAGING PERFORMED REVEALED A SMALL AMOUNT OF LOW-DENSITY MATERIAL (A NARROW RIM) WITHIN THE STENT, AND THE HOUNSFIELD UNITS WERE CONSISTENT WITH PLAQUE PROLAPSE. IT WAS ALSO NOTED THAT THE ACTIVATED CLOTTING TIME (ACT) WAS NOT IN RANGE. THE PATIENT REMAINED HOSPITALIZED BEYOND THE STANDARD OF CARE. THERE WAS NO P2Y12 TEST PERFORMED BUT THE PATIENT WAS SWITCHED TO 100 MG ASPIRIN AND BRILINTA. THE PATIENT SYMPTOMS HAD IMPROVED BUT NOT COMPLETELY RESOLVED THE FOLLOWING DAY, AND THEY WERE DISCHARGED TO CONTINUE TO HEAL AT HOME.

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

  MAUDE report 24471446 ↗
• InjuryOct 20, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS INADVERTENTLY DEPLOYED IN THE EXTERNAL CAROTID, REQUIRING AN UNPLANNED ADDITIONAL STENT PLACEMENT. THE PATIENT PRESENTED AS ASYMPTOMATIC. AN ENROUTE TRANSCAROTID STENT SYSTEM WAS SELECTED FOR USE FOR A RIGHT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. DURING THE INITIAL CONTRAST RUN, THE EXTERNAL CAROTID ARTERY (ECA) APPEARED OCCLUDED, AS NO FLOW WAS OBSERVED TO ANY OF ITS BRANCHES. THE PHYSICIAN PROCEEDED TO CROSS THE LESION, AND THE GUIDEWIRE FOLLOWED WHAT APPEARED TO BE THE NORMAL CURVATURE. UPON STENT DEPLOYMENT AND SUBSEQUENT IMAGING, IT WAS REVEALED THAT THE STENT HAD BEEN INADVERTENTLY PLACED IN THE ECA. THE PHYSICIAN THEN SUCCESSFULLY NAVIGATED THROUGH THE STENT INTO THE INTERNAL CAROTID ARTERY (ICA), BALLOONED OPEN THE INITIAL STENT, AND DEPLOYED AN ADDITIONAL STENT INTO THE ICA. IMAGING CONFIRMED THAT ALL STRUCTURES REMAINED INTACT, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336228 ↗
• InjuryMay 15, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT WAS SURGICALLY EXPLANTED. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE STENT WAS DEPLOYED WITHOUT ISSUE, BUT THE DELIVERY SYSTEM WAS UNABLE TO BE REMOVED. THE PHYSICIAN USED THE 0.014 BUDDY WIRE TECHNIQUE, AND POST-DILATED WITH ANOTHER BALLOON. THE PHYSICIAN MOVED THE CAROTID ARTERY MEDIALLY AND LATERALLY WHILE THE ANESTHESIOLOGIST MOVE THE PATIENT'S HEAD RIGHT AND LEFT WITH CHIN TOWARD CHEST. THE DELIVERY SYSTEM WAS STILL UNABLE TO BE REMOVED. THE PHYSICIAN ELECTED TO CONVERT THE TCAR PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA) AND SURGICALLY EXPLANT THE STENT. THE STENT WAS REMOVED IN ONE PIECE, AND THERE WAS NO VESSEL TRAUMA. FOLLOWING THE CEA, THE PATIENT WAS NEUROLOGICALLY INTACT. REMOVAL DIFFICULTY WAS ATTRIBUTED TO LESION CHARACTERISTICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029777 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE. THE PATIENT UNDERWENT A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE WITH NO NOTABLE ISSUES. THE FOLLOWING DAY, GREATER THAN 24 HOURS FOLLOWING THE TCAR PROCEDURE, FOLLOW UP WITH A HEALTHCARE PROFESSIONAL REVEALED THE PATIENT WAS EXPERIENCING A STROKE, WITH NOTABLE FACIAL DROOP AND RIGHT SIDED WEAKNESS. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE FOR MONITORING. NO ADDITIONAL INTERVENTION WAS PERFORMED. AT THE TIME OF REPORTING, THE SYMPTOMS HAD NOT RESOLVED.

  Patient problems: Facial Paralysis; Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 21963624 ↗
• InjuryMar 3, 2025Adverse 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 EXPERIENCED NUMBNESS ON THEIR LEFT HAND. IMAGING REVEALED A SMALL EMBOLIC STROKE AND NO EVIDENCE OF THROMBUS WERE OBSERVED. ADDITIONALLY, THE PATIENT HAD A PREEXISTING CONDITION OF ATRIAL FIBRILLATION, WHICH COULD HAVE CONTRIBUTED TO THE EVENT BY PROVIDING AN ALTERNATIVE SOURCE FOR EMBOLI. ANTI-COAGULANTS WERE DISCONTINUED AFTER THE PROCEDURE. AT THIS TIME, IT IS UNCLEAR IF THE REPORTED EVENT IS DUE TO PROCEDURAL COMPLICATIONS, 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: Ischemia Stroke; Numbness

  MAUDE report 21505816 ↗
• MalfunctionNov 13, 2024Fracture; Fracture

  IT WAS REPORTED, THREE YEARS AFTER A RIGHT TCAR PROCEDURE, DURING AN UNRELATED PHYSICIAN VISIT RELATED TO A SUBCLAVIAN BYPASS, THE ANGIOGRAM REVEALED A RIGHT CAROTID STENT FRACTURE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT REPORTED AS A RESULT OF THE EVENT. THERE WAS NO INTERVENTION PERFORMED NOR PLANNED FOR THE RIGHT FRACTURED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679783 ↗
• InjuryOct 24, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED CONFUSION AND RIGHT-SIDED WEAKNESS. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN OCCLUDED STENT. THE PHYSICIAN REPORTED THAT THE PATIENT HAD A HEAVILY CALCIFIED LESION, AND THE STENT APPEARED CRUSHED BY PLAQUE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY, AND IT IS UNKNOWN IF THE SYMPTOMS HAVE COMPLETELY RESOLVED. ADDITIONALLY, THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT) AND HAD A PLATELET REACTIVITY UNIT (PRU) OF 165. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS DUE TO THE PATIENT'S ANATOMY OR A SILK ROAD MEDICAL DEVICE, HENCE IT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Confusion/ Disorientation; Ischemia Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion

  MAUDE report 20523831 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW DAYS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT PRESENTED WITH STROKE LIKE SYMPTOMS. IMAGING REVEALED STENT RESTENOSIS AND THE PHYSICIAN NOTED A DISEASED CLOT WITHIN THE STENT. THE PATIENT WAS THEN PLACED ON LYTIC THERAPY TO TREAT THE DISEASED CLOT, WHICH LED TO A HEMORRHAGIC BLEED AND SUBSEQUENT PATIENT'S DEMISE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT OF STROKE AND RESTENOSIS ARE RELATED TO PATIENT'S UNDERLYING CONDITION, PROCEDURAL ISSUES, RESISTANCE/NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THIS EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 19397446 ↗
• InjuryFeb 1, 2024Adverse 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 SUFFERED A STROKE WITH LEFT SIDE STROKE SYMPTOMS. IT IS UNCLEAR IF THROMBUS WAS PRESENT IN THE STENT. THE PHYSICIAN PERFORMED A THROMBECTOMY. 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: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 18625525 ↗
• InjuryJun 22, 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 EXPERIENCED BLURRED VISION AND RIGHT-SIDED WEAKNESS. COMPUTED TOMOGRAPHY (CT) REVEALED AN OCCLUDED STENT. A CAROTID ENDARTERECTOMY (CEA) WAS PERFORMED, AND THE STENT WAS EXPLANTED, RESULTING IN A FULL RESOLUTION OF SYMPTOMS WITHIN 24 HOURS OF ONSET. 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 17184841 ↗
• InjuryApr 11, 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 RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT HAD NO MOVEMENT ON THE LEFT SIDE. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED THROMBUS IN THE STENT. THE PATIENT WAS TAKEN BACK TO THE OR ROOM, AND THE TCAR SITE WAS REOPENED TO PLACE AN ADDITIONAL STENT. MOVEMENT ON THE LEFT SIDE RETURNED. 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 16711163 ↗
• InjuryMar 7, 2023Adverse 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 TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A THROMBOSED STENT AND NEUROLOGICAL SYMPTOMS WHICH LED THE PHYSICIAN TO EXPLANT THE ENROUTE STENT. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED FAILURE IS RELATED TO A ENROUTE TRANSCAROTID STENT SYSTEM (TSS) FAILURE OR PATIENT RESISTANCE TO MEDICATION, OR A PROCEDURAL COMPLICATION, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 16499723 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 24 HOURS AFTER THE COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED THAT THE PROXIMAL PORTION OF THE ENROUTE STENT APPEARED TO BE SUBINTIMAL. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND PERFORM A CAROTID ENDARTERECTOMY (CEA). THE PATIENT WAS RECOVERING FROM THE CEA PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 15567518 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE DAYS AFTER THE COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED SUDDEN ONSET OF WEAKNESS AND SLURRED SPEECH. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE A STROKE WAS CONFIRMED AND RE-ADMITTED TO THE HOSPITAL WHERE IT WAS REPORTED THAT THE STENT COLLAPSED IN THE CENTER AND THE STENT HAD THROMBUS. THE PHYSICIAN PERFORMED A THROMBECTOMY, FOLLOWED BY ANGIOPLASTY, AND A SECONDARY 8X30 STENT WAS PLACED TO RESOLVE THE REPORTED ISSUE. IT WAS REPORTED THAT THE PATIENTS MEDICATION WAS SWITCHED FROM PLAVIX TO BRILLINTA. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HOWEVER NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Brain Injury; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 11029485 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PHYSICIAN STATED THAT THE PATIENT BECAUSE HYPOTENSIVE (~50-60 SYSTOLIC) IN THE RECOVERY ROOM. AFTER TREATING THE HYPOTENSION, SHE BECAME HYPERTENSIVE (~200-225 SYSTOLIC). THE PHYSICIAN NOTED THAT THE PATIENT EXPERIENCED A STROKE. THE PATIENT WAS TAKEN BACK TO SURGERY TO HAVE STENT REMOVED. THE PHYSICIAN REMOVED BLACK ULCERATED PLAQUE WITH WHITE SPECKS OF CALCIUM FROM THE STENT. THE PATIENT EXPERIENCED SLURRED SPEECH, FACIAL DROOP, AND LEFT SIDE WEAKNESS. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR RE-INTERVENTION AND POST-DILATION WAS PERFORMED. THE PATIENT WAS RETURNED TO THE ICU. THE FOLLOWING DAY, THE PATIENTS FACIAL DROOP AND LEG MOBILITY IMPROVED, HOWEVER THE LEFT ARM WEAKNESS REMAINED. THE PHYSICIAN NOTED THAT THERE WERE BLOOD PRESSURE ISSUES WITH THIS PATIENT THAT MAY HAVE CONTRIBUTED TO THE PATIENT HAVING A STROKE AND SUBSEQUENTLY HAVING THE STENT REMOVED.

  Patient problems: Brain Injury; Stroke/CVA

  MAUDE report 10846139 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX DAYS AFTER THE COMPLETION OF A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A STROKE. THE PATIENT HAS SINCE RECOVERED AND IS NEURO INTACT.

  Patient problems: Brain Injury; Stroke/CVA

  MAUDE report 10730740 ↗
• MalfunctionOct 22, 2020Break; Fracture; Break; Fracture

  AN ASYMPTOMATIC PATIENT SUCCESSFULLY RECEIVED A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE IN (B)(6) 2020 WITH NO REPORTED ISSUES. A ROUTINE ULTRASOUND PERFORMED ON (B)(6) 2020 REVEALED THAT THE PATIENT HAD ELEVATED VELOCITIES. IN (B)(6) 2020, IT WAS DETERMINED THAT THE STENTS INTEGRITY WAS UNCERTAIN AND THE PHYSICIAN RECOMMENDED TO EXPLANT THE STENT. THE STENT INTEGRITY WAS COMPROMISED UPON STENT EXPLANT. THE PATIENT REMAINED ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10718795 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. UPON REMOVAL OF ENROUTE ARTERIAL SHEATH PROTAMINE WAS REQUESTED BY THE PHYSICIAN. AFTER THE ACCESS SITE WAS CLOSED, THE PATIENT WAS AWAKE, ABLE TO SPEAK AND MOVE ARMS AND LEGS. THE PATIENT THEN BECAME HYPOTENSIVE, TACHYCARDIC, AND ITCHY. THE ANESTHESIOLOGIST STARTED EPINEPHRINE DRIP TO STABILIZE THE PATIENT AND THE PATIENT WAS ABLE TO RESPOND TO ALL COMMANDS WITH ALL EXTREMITIES. LATER THAT SAME DAY, THE PATIENT WAS NOT MOVING HER LEFT SIDE AND RECEIVED A CT SCAN WITH CONTRAST. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM TO HAVE THE ENROUTE STENT REMOVED. THE PATIENT'S STATUS DID NOT CHANGE POST EXPLANT, AND THE PATIENT EXPERIENCED SEIZURES AND INTRAPARENCHYMAL BLEEDS OVERNIGHT. THE FOLLOWING DAY, THE PATIENT WAS SPEAKING AND ABLE TO MOVE HER LEFT LEG. A VIDEO REVIEW WAS PERFORMED AFTER THE TCAR PROCEDURE THAT SHOWED STENT COMPRESSION AT THE PROXIMAL INTERNAL CAROTID ARTERY (ICA) WITH WHAT APPEARED TO BE MURAL THROMBUS IN THE DISTAL END OF THE STENT. THE ANGIOGRAMS TAKEN FROM FEMORAL ARTERY ACCESS DURING RE-INTERVENTION SHOWED THE STENT PATENT WITH APPROXIMATELY 30-50% RESIDUAL STENOSIS. THE PHYS

  Patient problems: Brain Injury; Convulsion/Seizure; Thrombosis/Thrombus

  MAUDE report 10505207 ↗
• MalfunctionMar 22, 2019Material Separation; Material Separation

  PATIENT HAD A TEVAR IN 2014 WITH THE PROXIMAL LANDING ZONE COVERING THE SUBCLAVIAN ARTERY. THE SUBCLAVIAN NEVER THROMBOSED OFF, AND THERE WAS A LARGE SEGMENT OF THROMBUS SITTING IN THE SC PROXIMAL TO HIS LEFT VERTEBRAL ARTERY AND LIMA (WHICH WAS BYPASSED TO HIS LAD). LEFT AXILLARY ARTERY WAS EXPOSED WITH CUTDOWN AND ACCESS WITH OUR ENHANCE MPK AND ENROUTE NPS ARTERIAL SHEATH WAS PLACED. REVERSE FLOW WAS ESTABLISHED WITH A VENOUS SHEATH IN THE RIGHT FEMORAL VEIN AND PROXIMAL CLAMPING OF THE AXILLARY ARTERY. THE LEFT VERTEBRAL ARTERY WAS WIRED AND A 6X30 ENROUTE STENT WAS PLACED. THE GOAL WAS TO SNORKLE THE STENT DOWN INTO THE SUBCLAVIAN TOWARDS THE AXILLARY ARTERY TO ACT AS A FILTER FOR ANY POTENTIAL THROMBUS. AN ADDITIONAL STENT (8X30) WAS LAID PROXIMALLY. UPON REMOVING THE SECOND STENT, THE TIP OF THE STENT BROKE OFF -- THE REST OF THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, AND WE WERE ABLE TO VISUALIZE THE DISTAL RADIOPAQUE TIP ON THE WIRE. A SECOND WIRE WAS PLACED INTO THE VERTEBRAL, AND THE SDS TIP WAS JAILED WITH A MDT ONYX CORONARY STENT. POST STENT ANGIO SHOWED FLOW TO THE BRAIN STEM. THERE WERE NO EEG CHANGES DURING THE CASE, AND THE PATIENT WOKE UP NEUROLOGICA

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 8446403 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TCAR PERFORMED. ONCE PATIENT REACHED RECOVERY ROOM, RIGHT SIDE WEAK. PATIENT RETURNED TO PROCEDURE ROOM AND STENT WAS OCCLUDED. CEA WAS PERFORMED AND STENTS WERE EXPLANTED.

  Patient problems: Patient Problem/Medical Problem; Thrombosis

  MAUDE report 8423247 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE COMPLETED SUCCESSFULLY ON FRI (B)(6) 2018. THE NEXT MORNING THE PATIENT'S BLOOD PRESSURE HAD DROPPED AFTER BEING GIVEN A CALCIUM CHANNEL BLOCKER FOR HIGH BLOOD PRESSURE. THE STENT THROMBOSED SHORTLY AFTERWARDS. PATIENT WAS BROUGHT TO NEURO-RADIOLOGY INTERVENTION WHERE THE STENT WAS DECLOTTED WITH A DEVICE WHICH BECAME STUCK ON THE ENROUTE STENT EDGE. VIGOROUS ATTEMPTS TO DISLODGE THE CLOTTING CATHETER CREATED A DISSECTION WHICH REQUIRED A SECOND STENT TO SEAL THE DISSECTION.

  Patient problems: Patient Problem/Medical Problem; Thrombosis; Vascular Dissection

  MAUDE report 7787955 ↗

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