XACT™ 82090-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 08717648010262), received between Aug 31, 2016 and May 18, 2026 — classified as 1 death, 25 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Premature Activation

  IT WAS REPORTED THAT WHEN THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS OPENED, THE STENT HEAD WAS NOTED TO BE EXPOSED AND NOT FLOWERING/OPENING. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SAME SIZE XACT SESS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210005 ↗
• MalfunctionFeb 19, 2026Difficult to Remove; Mechanical Jam; Activation Failure

  IT IS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 8TX40MM XACT CAROTID STENT SYSTEM WAS ADVANCED TO THE TARGET LESION ON A 0.014 ABBOTT GUIDE WIRE (GW). THE STENT WAS PARTIALLY RELEASED; HOWEVER, THE HANDLE BECAME STUCK AND THE STENT COULD NOT BE COMPLETELY RELEASED. THEREFORE, CAROTID STENT SYSTEM WAS REMOVED WITH THE SHEATH AND GUIDE CATHETER AS A SINGLE UNIT. THE PROCEDURE WAS CONTINUED WITH ANOTHER XACT STENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393028 ↗
• MalfunctionFeb 5, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS INTERNAL CAROTID ARTERY THAT IS 80% STENOSED. WHEN ROTATING THE RELEASE KNOB [HANDLE] OF THE 8X40MM XACT CAROTID SELF-EXPANDING STENT (SES), THE STENT WAS PARTIALLY DEPLOYED (EXPOSED). A NEW 6-8X40MM ACCULINK CAROTID SES WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273035 ↗
• MalfunctionJan 2, 2026Activation Failure

  SUBSEQUENT TO THE INITIALLY FILED REPORTS THE DEVICE WAS RECEIVED AND THE STENT WAS NOT DEPLOYED AT ALL. THE ACCOUNT STATED THAT THE PARTIAL DEPLOYMENT WAS REPORTED IN ERROR AND THE STENT COMPLETELY FAILED TO DEPLOY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950822 ↗
• MalfunctionDec 5, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE INTERNAL CAROTID ARTERY. THE 8-6X40MM XACT SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED OVER THE BAREWIRE HOWEVER RESISTANCE WAS MET AND THE SES WAS UNABLE TO ADVANCE. THE SES WAS REMOVED AND THE SHAFT SEPARATED AND THE STENT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER XACT STENT AND THE SAME BAREWIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727744 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2025, TO TREAT A MODERATELY CALCIFIED RIGHT COMMON CAROTID ARTERY AND RIGHT INTERNAL CAROTID ARTERY. THE 8X40MM XACT CAROTID STENT WAS SUCCESSFULLY DEPLOYED IN THE COMMON CAROTID ARTERY. AFTER DEPLOYMENT, THROMBUS WAS NOTED INSIDE THE STENT. THROMBECTOMY WAS PERFORMED AND IMAGING SHOWED "NO FLOW" TO THE BRAIN. THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK WITH FACIAL DROOPING, LEFT SIDE WEAKNESS, THE INABILITY TO SPEAK, PAIN, AND HYPERTENSION. TISSUE PLASMINOGEN ACTIVATOR WAS GIVEN FOR TREATMENT AND THROMBECTOMY WAS PERFORMED AGAIN. BLOOD FLOW WAS RESTORED AND 2 ACUTE CLOTS WERE CAPTURED BY THE FILTER. COMPUTED TOMOGRAPHY SCAN WAS PERFORMED WHICH WAS NEGATIVE FOR EMBOLI. ON (B)(6) 2025, THE PATIENT WAS SENT TO THE ICU FOR FURTHER CARE. THERE WERE NO RESIDUAL DEFICITS AND THE PATIENT WAS ABLE TO PASS NEUROLOGICAL EXAMS. THE HYPERTENSION WAS NOT TREATED, NOR DID IT RESOLVE DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension; Pain; Paresis; Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 23633866 ↗
• MalfunctionNov 20, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY. THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS OPENED BUT IT WAS FOUND THAT THE INNER PACKAGING WAS ALREADY OPENED. THEREFORE THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY ONLY. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607190 ↗
• MalfunctionOct 16, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CAROTID ARTERY WITH MILD TORTUOSITY. THE 8TX40X136 XACT SELF EXPANDING STENT (SES) WAS DEPLOYED BUT THERE WAS RESISTANCE AS THE DELIVERY SYSTEM WAS CAUGHT ON THE DISTAL END OF THE IMPLANTED STENT. UPON REMOVAL, AN EMBOSHIELD NAV 6 FILTER WAS ALSO IN THE PATIENT AND THE WIRE GOT KINKED AND THE FILTER MOVED PROXIMALLY DURING REMOVAL OF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM AND EMBOSHIELD WERE REMOVED TOGETHER. THERE WERE NO ISSUES WITH THE IMPLANTED STENT AND IT IS IN THE INTENDED LOCATION. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS A SLIGHT DELAY DUE TO NAVIGATING FOR REMOVAL BUT NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312723 ↗
• MalfunctionJan 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE RIGHT INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION. THE XACT 8TX40X136MM CAROTID ARTERY STENT SYSTEM WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT WAS NOTED TO SLIP BACK ON THE DELIVERY SYSTEM DURING ADVANCEMENT. THEREFORE, THE XACT STENT SYSTEM WAS REMOVED FROM THE PATIENT. ANOTHER SAME SIZE XACT STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21070528 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CAROTID ARTERY. AN EMBOSHIELD NAV6 WAS PREPPED SUCCESSFULLY AND ADVANCED IN THE ANATOMY WITHOUT ISSUE. THE FILTER WAS DEPLOYED WITHOUT ISSUE. AN 8X40X136 XACT STENT WAS ADVANCED AND DEPLOYED WITHOUT ISSUE. POST DILATATION WAS PERFORMED WITH 5.0 UNSPECIFIED BALLOON AND THEN WITH A 5.5 NON-COMPLIANT BALLOON. HOWEVER AFTER THE POST DILATATION WITH THE SECOND BALLOON WAS PERFORMED A SMALL AMOUNT OF BLOOD (PERFORATION) WAS OBSERVED. BALLOON TAMPONED WAS PERFORMED ALONG WITH APPLYING PRESSURE ON THE NECK PHYSICALLY AND NO MORE BLOOD WAS VISIBLE. HOWEVER, IT WAS NOTED PRIOR TO THE PROCEDURE MEDICATION WAS GIVEN TO THE PATIENT AS THEY HAD VERY HIGH BLOOD PRESSURE. ONCE THE TAMPONED WAS PERFORMED BLOOD PRESSURE DECREASED RAPIDLY, ST ELEVATIONS WERE NOTED, MEDICATION WAS GIVEN, BUT PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA LEADING INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED HOWEVER, UNSUCCESSFUL AND PATIENT EXPIRED. IT WAS NOTED PATIENT WAS FINE POST CAROTID PROCEDURE AND PER THE PHYSICIAN'S OPINION THE DEATH WAS NOT RELATED TO THE ABBOTT DEVICE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFO

  Patient problems: Perforation of Vessels

  MAUDE report 20612618 ↗
• InjuryMay 22, 2024Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE INTERNAL CAROTID ARTERY. THE 8-6-40 XACT STENT WAS IMPLANTED WITHOUT ISSUE. TWO MONTHS POST PROCEDURE THE PATIENT PRESENTED WITH DIZZINESS AND IT WAS NOTED THE STENT HAD FRACTURED. A SECOND XACT STENT WAS IMPLANTED AS TREATMENT.

  Patient problems: Dizziness

  MAUDE report 19377038 ↗
• InjuryMar 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A XACT SELF EXPANDING STENT WAS IMPLANTED ON A BEND TO TREAT THE LEFT INTERNAL CAROTID ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. ONE YEAR LATER AT FOLLOW UP ON (B)(6) 2024, THE STENT WAS NOTED TO BE SEPARATED AND THERE WAS THROMBOSIS INSIDE THE STENT CONFIRMED BY ANGIOGRAPHY, AND SEVERE STENOSIS OCCURRED. NO TREATMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 18987897 ↗
• MalfunctionSep 12, 2023Difficult or Delayed Activation; Mechanical Jam; Difficult or Delayed Activation; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LEFT INTERNAL CAROTID ARTERY THAT IS 90% STENOSED. THE VESSEL WAS PREPPED WITH 4X30MM VIATRAC BALLOON TO ATMOSPHERES FOR 3 SECONDS. THE 8TX40X136 XACT STENT KNOB DID NOT ROTATE DURING DEPLOYMENT; THEREFORE, THE TWO SURGEONS JOINTLY USED VERY LARGE FORCES TO COMPLETE THE RELEASE OF THE STENT. THE STENT WAS IMPLANTED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729777 ↗
• MalfunctionJul 24, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS, 75% STENOSED, DE NOVO LESION IN THE DISTAL INTERNAL CAROTID ARTERY. DURING PRE-OPERATIVE INSPECTION OF AN 8TX40X136 XACT SELF-EXPANDING STENT SYSTEM (SESS), IT WAS NOTED THAT THE TIP OF THE STENT DELIVERY CATHETER WAS EXPOSED AND COULD NOT BE USED. A NEW SAME SIZE XACT SESS WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379975 ↗
• MalfunctionJan 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING REMOVAL OF THE EXACT CAROTID STENT DELIVERY SYSTEM (SDS) FROM THE TRAY, IT WAS NOTED THAT THE DELIVERY SYSTEM WAS BROKEN IN TWO SEPARATE PIECES. ANOTHER EXACT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16255062 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CAROTID ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE PATIENT HAS A PRIOR HISTORY OF TRANSIENT ISCHEMIC ATTACK ON THE LEFT SIDE. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) AND XACT CAROTID STENT WERE USED IN THE PROCEDURE WITHOUT ISSUE AND THE STENT WAS POST-DILATED WITH A 5.0 VIATRAC BALLOON. ONCE THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) IT WAS NOTED THAT THEY HAD RIGHT SIDED PARALYSIS INVOLVING THE ARM, LEG, AND FACE. A STROKE ALERT WAS CALLED AND NEUROLOGY ON BOARD. A COMPUTED TOMOGRAPHY SCAN AND MRI WERE PERFORMED AND AN EMBOLIC STROKE WAS DIAGNOSED WITH MIDDLE CEREBRAL ARTERY EMBOLISM. SYMPTOMS LASTED 48 HOURS. THE PATIENT WAS UNABLE TO RECEIVE TISSUE PLASMINOGEN ACTIVATOR (TPA) DUE TO STENT PLACEMENT. THE PATIENT WAS HOSPITALIZED DUE TO THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Stroke/CVA

  MAUDE report 15809209 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD 8X40X136 XACT STENT IMPLANTED ON (B)(6) 2022. THE FOLLOWING MORNING THE PATIENT SUFFERED RIGHT SIDE DRIFT AND SLURRED SPEECH. A COMPUTERIZED TOMOGRAPHY (CT) HEAD/NECK WAS PERFORMED AND CONFIRMED THE PATIENT SUFFERED A STROKE. THE CT DID REVEAL THE STENT WAS OCCLUDED WITH THROMBUS. THE STROKE WAS TREATED WITH HEPARIN AND THROMBOSIS WAS TREATED WITH TISSUE PLASMINOGEN ACTIVATOR (TPA). THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 15267796 ↗
• InjuryApr 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED INTERNAL CAROTID ARTERY THAT IS 92% STENOSED. THE 8X40X136MM XACT SELF-EXPANDING STENT SYSTEM WAS IMPLANTED; HOWEVER, THE PATIENT WAS TRANSFERRED TO SURGERY FOR CAROTID ENDARTERECTOMY. THE STENT WAS STRIPPED OUT DUE TO THE CALCIFICATION OF THE LESION THE STENT COULD NOT OPEN THE NARROW BLOOD VESSEL [RECOIL]. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142853 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED FOR A PERCUTANEOUS LEFT CAROTID INTERVENTION WITH MODERATE CALCIFICATION. AN EMBOSHIELD NAV 6 FILTER WAS SUCCESSFULLY PLACED, AND PRE-DILATATION WAS SUCCESSFULLY PERFORMED USING A VIATRAC BALLOON CATHETER. AN XACT STENT WAS DEPLOYED WITHOUT A DEVICE ISSUE, FROM THE INTERNAL CAROTID TO COMMON CAROTID, WITH TORTUOUS VESSEL VASCULATURE OBSERVED DISTAL. POST-STENT IMPLANTATION, CAROTID VASOSPASMS OCCURRED, DISTAL TO THE STENT, THE PATIENT BECAME HYPOTENSIVE AND THERE WERE CONCERNS FOR A CEREBRAL VASCULAR ACCIDENT. MEDICATIONS WERE PROVIDED AS TREATMENT AND PROLONGED HOSPITALIZATION WAS REQUIRED FOR OBSERVATION. PER IMAGING, TRANSIENT CEREBRAL VASCULAR HYPOPERFUSION, WITH LIMITED CAROTID FILLING WAS NOTED. THERE WAS NO OCCLUSION OR THROMBUS OBSERVED. NEITHER A CEREBRAL VASCULAR ACCIDENT OR TRANSIENT ISCHEMIC ATTACK WERE DIAGNOSED. THE PATIENT STABILIZED, WITHOUT ADDITIONAL ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Low Blood Pressure/ Hypotension; Nervous System Injury; Vasoconstriction

  MAUDE report 13581611 ↗
• InjuryDec 17, 2021Loose or Intermittent Connection; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Loose or Intermittent Connection; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE LEFT INTERNAL CAROTID, MILDLY CALCIFIED LESION. A BAREWIRE AND 90CM COOK SHUTTLE SHEATH WERE PLACED WITHOUT ISSUES. FOLLOWING, AN XACT STENT DELIVERY SYSTEM (SDS) ADVANCED INTO POSITION, ACROSS THE LESION. AS PROTOCOL, NEGATIVE WAS APPLIED TO THE SHEATH WHEN AIR WAS OBSERVED RETRACTING INTO THE SYRINGE. AS PREVENTION, ADDITIONAL ASPIRATION WAS PERFORMED. THE XACT SDS WAS REMOVED, AND THE PHYSICIAN TIGHTENED THE TUOHY BORST OVER THE 014 WIRE. FOLLOWING, NO MORE AIR WAS OBSERVED IN THE SYRINGE WHEN ASPIRATION WAS APPLIED WITHOUT THE XACT SDS. THE PHYSICIAN WAS CONCERNED THAT THE XACT SDS HAD A KINK, TEAR, OR THE SHAFT WAS NOT PERFECTLY ROUND, OR THE CONNECTION BETWEEN THE XACT SHAFT AND TUOHY BORST WAS ALLOWING AIR TO RETRACT INTO THE SYRINGE, CAUSING THE AIR RETRACTION WHEN NEGATIVE WAS APPLIED. A TEAR OR KINK WERE NOT OBSERVED. THE SAME XACT WAS RE-INSERTED ONTO THE SAME BAREWIRE WHEN UNUSUAL RESISTANCE/STICKINESS WAS FELT DURING ADVANCEMENT, REPORTEDLY THIS WAS DUE TO DRYING BLOOD INSIDE THE XACT LUMEN. THE XACT WAS FLUSHED, AND NO ADDITIONAL STICKINESS WAS NOTED FOLLOWING. ADDITIONAL ASPIRATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13029268 ↗
• MalfunctionAug 23, 2021Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN INTERNAL CAROTID ARTERY THAT WAS 90% STENOSED. AN XACT STENT WAS ADVANCED TO THE LESION AND DEPLOYMENT INITIATED. HOWEVER, IT WAS NOTED THAT THE RELEASE KNOB OF THE DEVICE COULD NOT BE TURNED NORMALLY AND THE STENT COMPLETELY FAILED TO DEPLOY. A NEW XACT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL PER DEVICE ANALYSIS CONFIRMED THAT [THE DISTAL END OF THE STENT IMPLANT WAS PARTIALLY EXPANDED OVER THE TIP FOR A LENGTH OF 6MM]. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353852 ↗
• MalfunctionJun 23, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING PREP, THE STENT OF A 8X40MM XACT SELF EXPANDING STENT SYSTEM (SESS) WAS NOTED TO BE EXPOSED BUT NOT FLOWERING. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054160 ↗
• InjuryJun 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH 75% STENOSIS. ON (B)(6) 2020, THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A 8.0X40MM XACT STENT IN THE RIGHT ICA. ON (B)(6) 2021, A SECOND PROCEDURE WAS PERFORMED AS THE PREVIOUSLY IMPLANTED STENT HAD BECOME SEPARATED AND IT WAS NOTED THE STENT HAD 63% RE-STENOSIS AT THE FRACTURED SITE. A NEW STENT WAS PLACED OVER THE SEPARATED STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 11921202 ↗
• MalfunctionMay 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY. A 8X40MM XACT SELF-EXPANDING STENT WAS IMPLANTED ON (B)(6) 2019. ON (B)(6)2021, THE PATIENT WAS ADMITTED INTO THE HOSPITAL, AND IT WAS DISCOVERED THAT THE IMPLANTED STENT HAD SEPARATED. THE PATIENT WAS ASYMPTOMATIC, AND THERE WAS NO TREATMENT PERFORMED. THE REASON THE PATIENT WAS READMITTED INTO THE HOSPITAL WAS NOT RELATED TO AN ISSUE WITH THE ABBOTT STENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11902307 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE COMMON CAROTID ARTERY. AN 8X40MM XACT SELF-EXPANDING STENT SYSTEM (SESS) WAS USED WITHOUT ISSUE. ONE HOUR AFTER THE PROCEDURE, THE PATIENT DEVELOPED HEMIPARESIS OF THE RIGHT LIMB, SLURRED SPEECH, AND THROMBOSIS. SUCTION, THROMBECTOMY, AND THROMBOLYSIS WERE PERFORMED. ANGIOGRAPHY CONFIRMED THAT THE THROMBUS IN THE STENT WAS COMPLETELY CLEARED AND THE BLOOD FLOW IN THE STENT WAS NORMAL. ADDITIONALLY, THE HEMIPARESIS AND SLURRED SPEECH WERE RESOLVED. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Nervous System Injury; Paresis; Thrombosis/Thrombus

  MAUDE report 11649290 ↗