Acculink™ 1011344-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08717648076398), received between Aug 22, 2016 and Jul 28, 2026 — classified as 10 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052762 ↗
• MalfunctionMar 30, 2026Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE CAROTID ARTERY. DURING PREPARATION OF THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS), THE DISTAL END OF THE DELIVERY CATHETER WAS BENT, MAKING IT IMPOSSIBLE TO INSERT THE FILTER INTO THE DELIVERY CATHETER. A NEW NAV6 WAS USED WITHOUT ISSUE. THE 7-10/40 ACCULINK SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT, THE HANDLE SLIDER WAS ADVANCED HOWEVER THE STENT FAILED TO DEPLOY. DEPLOYMENT WAS ATTEMPTED AGAIN HOWEVER NO STENT DEPLOYED. THE SES WAS REMOVED AND THE PROCEDURE COMPLETED USING A NEW ACCULINK. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE STENT IMPLANT WAS PARTIALLY DEPLOYED (FLOWERED) 1.5 CENTIMETERS (CM) FROM THE DISTAL END OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713721 ↗
• MalfunctionDec 16, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY TO HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE LEFT CAROTID ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EBS) WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. THE EBS LOST CANULATION WITH THE CATHETER AND THE VESSEL HAD TO BE RE-CANULATED. NEXT A 4.0X30MM VIATRAC PLUS BALLON CATHETER WAS ADVANCED AND THE LESION WAS DILATED WITHOUT ISSUES. A 10TX40X136MM XACT SELF EXPANDING STENT SYSTEM (SES) WAS BEING ADVANCED, BUT RESISTANCE WITH THE ANATOMY WAS FELT THEREFORE IT WAS REMOVED. A 7X10X40MM ACCULINK SES WAS ADVANCED WITHOUT ISSUES; HOWEVER, DURING DEPLOYMENT THE STENT JUMPED AND THE STENT DEPLOYED BUT MISSED ABOUT 20% OF THE LESION. THE PREVIOUSLY USED 10TX40X136MM XACT SES WAS ADVANCED AND DEPLOYED AT THE REST OF THE 20% OF THE LESION OVERLAPPING WITH THE ACCULINK STENT. AN ANGIOGRAM WAS PERFORMED AND FLOW WAS NOTED. WENT IN TO RETRIEVE THE NAV6 FILTER AND IT WAS REMOVED WITHOUT INCIDENT. REPEATED ANGIOGRAM AND IT WAS DISCOVERED THERE WAS NO FLOW AND THE PATIENT HAD A SPASM WHICH LED TO A STROKE. MEDICINE AND NURO INTERVENTION WAS PERFORMED TO TRY AND PULL OUT THE CLOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817449 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN INTERNAL CAROTID ARTERY. THE 7-10/40 ACCULINK STENT DELIVERY SYSTEM TIP WAS NOTED TO BE SEPARATED ONCE REMOVED FROM THE PACKAGING AND WAS NOT USED IN THE ANATOMY. ANOTHER ACCULINK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780311 ↗
• MalfunctionMay 6, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED DE NOVO LESION IN THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 7-10X40MM ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED ON A BAREWIRE TO THE TARGET LESION AND AN ATTEMPT WAS MADE TO RELEASE THE STENT; HOWEVER, THE STENT WAS NOT ABLE TO BE RELEASED AND COMPLETELY FAILED TO DEPLOY. THEREFORE, THE SESS WAS REMOVED FROM THE PATIENT AND ANOTHER ACCULINK SESS WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THE DISTAL END OF THE 7-10X40MM ACCULINK SELF EXPANDING STENT WAS EXTENDING DISTALLY FROM DISTAL END OF STENT SHEATH FOR A LENGTH OF 0.5MM (MILLIMETERS). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971867 ↗
• MalfunctionMay 24, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY. THE 7-10X40MM ACCULINK CAROTID STENT SYSTEM WAS ADVANCED ON A 0.014 GUIDE WIRE TO THE TARGET LESION AND THE STENT WAS ATTEMPTED TO BE DEPLOYED. HOWEVER, THE STENT WOULD ONLY PARTIALLY DEPLOY. THEREFORE, THE ACCULINK CAROTID STENT SYSTEM WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392954 ↗
• MalfunctionMay 17, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE LEFT INTERNAL AND EXTERNAL CAROTID ARTERY. THE LESION WAS PRE-DILATED WITH A 5.0X30MM VIATRAC BALLOON CATHETER. A 7.0X10MM ACCULINK SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER WHEN PULLING HANDLE THE STENT DID NOT DEPLOY. THE HANDLE WAS RETRACTED A LITTLE BIT AND PULLED BACK AGAIN HOWEVER THE STENT STILL DID NOT DEPLOY. THE SES WAS REMOVED AND REPLACED WITH ANOTHER ACCULINK OF THE SAME SIZE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE OUTER MEMBER WAS SEPARATED FROM THE SLIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340341 ↗
• InjuryApr 18, 2024Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CAROTID VESSEL WITH NO CALCIFICATION AND MODERATE TORTUOSITY. THE 7.0X10MM ACCULINK SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION AND UPON DEPLOYMENT, THE SLIDER BECAME STUCK AND STENT WAS NOT DEPLOYED. DURING WITHDRAWAL OF THE SES, THE SLIDER RELEASED AND THE STENT DEPLOYED PROXIMAL TO THE TARGET LESION IN HEALTHY TISSUE. THE PROCEDURE WAS ABORTED AT THIS TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19134476 ↗
• InjuryFeb 23, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS DEPLOYED AT THE TARGET LOCATION. THE 7-10X40MM ACCULINK SELF EXPANDING STENT (SES) WAS ADVANCED TO THE LESION THROUGH A 6F 80CM NON-ABBOTT SHEATH OVER AN UNSPECIFIED 0.014 GUIDE WIRE. THE STENT DELIVERY SYSTEM HANDLE WAS PULLED ALL THE WAY, WITH NO RESISTANCE NOTED; HOWEVER, THE ACCULINK STENT WAS ONLY PARTIALLY DEPLOYED AT THE TARGET SITE. THE NON-ABBOTT SHEATH WAS RAISED AS MUCH AS POSSIBLE AND THE ACCULINK DELIVERY CATHETER WAS REMOVED, WITH HALF OF THE STENT REMAINING IN THE GUIDING CATHETER. USING THE EPS RETRIEVAL CATHETER, THE STENT WAS PUSHED FROM THE GUIDING CATHETER AND WAS ABLE TO BE COMPLETELY DEPLOYED PARTIALLY INSIDE THE TARGET LESION AND PARTIALLY IN HEALTHY TISSUE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767783 ↗
• MalfunctionJul 20, 2023Difficult to Remove; Difficult to Advance; Mechanical Jam; Activation Failure; Difficult to Remove; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY WITH MODERATE TORTUOSITY. AN EMBOSHIELD NAV6 FILTER WAS DEPLOYED. THE 7-10 ACCULINK CAROTID STENT SYSTEM WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. DURING AN ATTEMPT TO DEPLOY THE STENT, RESISTANCE WAS FELT ON THE THUMBSLIDE. AFTER SEVERAL ATTEMPTS THE STENT COMPLETELY FAILED TO DEPLOYED. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE ANATOMY. ANOTHER ACCULINK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364160 ↗
• MalfunctionJun 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE ACCULINK STENT WAS TO BE USED TO TREAT THE DISTAL INTERNAL CAROTID ARTERY. HOWEVER, DURING PREPARATION AND BEFORE USE OF THE DEVICE, IT WAS NOTED THAT THE NOSE CONE WAS NOT FIXED TO THE CATHETER. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. THE DECISION WAS MADE TO TREAT THE PATIENT WITH A CAROTID ENDARTERECTOMY PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140322 ↗
• MalfunctionAug 26, 2022Difficult to Advance; Mechanical Jam; Activation Failure; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN INTERNAL CAROTID ARTERY. AN RX .014 ACCULINK 7-10/40 STENT WAS ADVANCED TO THE LESION, ALTHOUGH RESISTANCE WITH A GUIDE WIRE WAS NOTED IT ULTIMATELY REACHED THE LESION. DEPLOYMENT WAS INITIATED, HOWEVER, THE STENT WAS RELEASED TO 1/3, THERE WAS GREAT RESISTANCE IN RETRACTING THE HANDLE AND THE STENT COULD NOT BE RELEASED ANY MORE. IT WAS DECIDED TO WITHDRAW THE DEVICE AND REPLACED WITH A NON-ABBOTT STENT THAT SUCCESSFULLY COMPLETED THE PROCEDURE. 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 15306874 ↗
• InjuryJul 15, 2022Adverse 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 HEAVILY CALCIFIED AND TORTUOUS RIGHT COMMON CAROTID ARTERY. THE PROCEDURE WAS PERFORMED PLACING AN EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE AT THE TARGET SITE. PRE DILATATION WAS PERFORMED USING A VIATRAC DILATATION CATHETER. AN ACCULINK STENT DELIVERY SYSTEM WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE, AND DEPLOYED WITHOUT ISSUE. AS STANDARD PROCEDURE, POST DILATATION WAS PERFORMED USING A NON-ABBOTT DILATATION CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS OR DEVICE ISSUES NOTED DURING THE PROCEDURE. LATER, ON THE EVENING OF THE PROCEDURE, THE PATIENT EXPERIENCED BREATHING DIFFICULTY AND RESUSCITATION WAS PERFORMED. IT WAS NOTED THAT A HEMATOMA HAD OCCURRED AND WAS OBSTRUCTING THE PATIENT'S AIRWAY. IT WAS THOUGHT THAT THE HEMATOMA HAD FORMED OVER A PERFORATION THAT HAD OCCURRED DURING THE PROCEDURE, BUT WAS NOT NOTED. THE HEMATOMA RESOLVED ON ITS OWN, WITH NO ADDITIONAL INTERVENTION REQUIRED. THE PATIENT CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; Hypoxia; Perforation of Vessels

  MAUDE report 15033964 ↗
• InjuryJun 30, 2022Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY WITH MILD TORTUOSITY AND MODERATE CALCIFICATION AND 70% STENOSIS. ON (B)(6) 2021 THE 7-10X40 MM ACCULINK CAROTID STENT SYSTEM (CSS) WAS IMPLANTED WITHOUT ISSUE. ON 06/07/2022 IT WAS DISCOVERED THAT THE STENT HAD MIGRATED FOR AN UNKNOWN REASON. THE STENT IS COMPLETELY OUT OF THE TARGET LESION. A NON-ABBOTT STENT WAS USED TO OVERLAP AND TREAT THE LESION.

  Patient problems: Foreign Body In Patient

  MAUDE report 14877420 ↗
• MalfunctionMay 6, 2022Break; Mechanical Jam; Activation Failure; Break; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS INTERNAL CAROTID ARTERY THAT IS 95% STENOSED. THE LESION WAS PREPPED WITH A 4X20MM VIATRAC BALLOON INFLATED TO 8 ATMOSPHERES FOR 2 SECONDS. THE 7-10X40MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE SAFETY LOCK WAS TURNED COUNTER-CLOCKWISE TO THE DEPLOYMENT POSITION. THE HANDLE WAS PULLED BACK TO DEPLOY THE STENT; HOWEVER, THE STENT COMPLETELY FAILED TO DEPLOY. THE ACCULINK WAS WITHDRAWN UNDER FLUOROSCOPY AND REPLACED WITH A 9-7X40MM XACT STENT TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THE STENT WAS RETURNED PARTIALLY DEPLOYED, WITH DISTAL END RING 1 STRUT EXPOSED FROM THE SHEATH. THERE WAS SHAFT SEPARATION FROM THE SLIDER NOTED ONCE THE HANDLE HALVES WERE OPENED. THE SHAFT SEPARATION REMAINED IN ONE PIECE AS SHAFT WAS STILL HELD TOGETHER BY THE HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311164 ↗
• MalfunctionDec 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING PREPARATION OF THE 7-10X40MM RX .014 ACCULINK SELF-EXPANDING STENT SYSTEM (SESS), THE DEVICE WAS BEING FLUSHED AND LIQUID SPRAYED OUT THE SIDE OF THE DEVICE (HUB). ANOTHER SAME SIZE ACCULINK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052732 ↗
• MalfunctionOct 15, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, 70% STENOSED, DE NOVO LESION IN THE CAROTID ARTERY. DURING PREPARATION, A .014 ACCULINK 7-10/40 SELF-EXPANDING STENT (SES) WAS OPENED FOR PREPARATION WHEN IT WAS NOTED THAT THE TIP OF THE SES WAS MISSING. THE TIP WAS NOT FOUND IN THE PACKAGING, IT WAS NOT PRESENT AT ALL UPON OPENING THE PACKAGE. THE SES WAS NOT USED IN THE PATIENT AND ANOTHER SAME SIZE ACCULINK SES WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642698 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 10TX40X136 XACT CAROTID STENT WAS IMPLANTED TO TREAT AN OCCLUSION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LEFT VERTEBRAL ARTERY. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A SECOND PLANNED PROCEDURE IN ANOTHER VESSEL; HOWEVER, IT WAS NOTED THAT THE XACT STENT IMPLANTED IN MAY WAS BROKEN CIRCUMFERENTIALLY AND SEVERELY BLOCKING THE BLOOD FLOW. A 7-10/40 ACCULINK STENT WAS IMPLANTED AS TREATMENT, RELIEVING THE PATIENT SYMPTOMS. POST PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL INFARCTION FROM THROMBUS AND WAS HOSPITALIZED FOR OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 12305077 ↗
• MalfunctionFeb 19, 2021Break; Activation Failure; Break; Activation Failure

  IT WAS REPORT THAT THE PROCEDURE WAS TO TREAT A CAROTID ARTERY. AFTER PRE-DILATATION WAS PERFORMED A NON-ABBOTT EMBOLIC PROTECTION SYSTEM WAS USED. THE LESION WAS PRE-DILATATED AGAIN AND ANGIOGRAPHY REVEALED STENOSIS WAS SIGNIFICANTLY IMPROVED. A .014 RX ACCULINK SELF EXPANDING STENT WAS ADVANCED AND ONCE AT THE LESION THE STENT FAILED TO DEPLOY AFTER MANY ATTEMPTS. THE PHYSICIAN DECIDED TO PERFORM ANOTHER PROCEDURE AT A LATER DATE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. PER DEVICE ANALYSIS IT WAS OBSERVED THAT THE SHAFT WAS SEPARATED 7.5CM PROXIMAL TO THE DISTAL END OF THE STRAIN RELIEF. THE HYPOTUBE WAS STILL INTACT HOLDING BOTH PIECES TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 11349274 ↗
• InjuryFeb 8, 2021Material Separation; Patient-Device Incompatibility; Material Separation; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-CALCIFIED, NON-TORTUOUS RIGHT INTERNAL CAROTID ARTERY. A 7-10X40MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED, AND THE STENT WAS DEPLOYED. THE STENT HAD NOT FULLY APPOSED TO THE VESSEL WALL, AND IT WAS NOTED THAT THE TIP HAD SEPARATED. A SNARE WAS ATTEMPTED TO REMOVE THE SEPARATED TIP BUT WAS UNSUCCESSFUL. AN UNSPECIFIED STENT WAS TO EMBED THE TIP AND FIX THE POORLY APPOSED ACCULINK STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 11298193 ↗
• MalfunctionNov 23, 2020Break; Deformation Due to Compressive Stress; Difficult to Advance; Activation Failure; Break; Deformation Due to Compressive Stress; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 95% STENOSED, DE NOVO INTERNAL CAROTID ARTERY (ICA). THE 0.14 ACCULINK CAROTID STENT DELIVERY SYSTEM (SDS) WAS SLOWLY ADVANCED TO THE LESION WITH RESISTANCE MET DUE TO THE DIFFICULT ANATOMY. ONCE THE SDS REACHED THE LESION, SEVERAL ATTEMPTS WERE MADE TO RELEASE THE STENT, BUT IT FAILED TO DEPLOY. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10886086 ↗
• InjuryMay 14, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT CAROTID ARTERY THAT WAS CALCIFIED AND TORTUOUS. THE EMBOSHIELD WAS POSITIONED AND DEPLOYED DISTAL TO THE LESION WITHOUT ANY ISSUES. THE ACCULINK STENT WAS ADVANCED TO THE LESION. THE SHEATH WAS RE-POSITIONED BUT LOST POSITION, RESULTING IN THE STENT DEPLOYING IN AN UNINTENDED LOCATION, POSSIBLY IN THE LEFT COMMON CAROTID. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. WHILE PULLING THE EMBOSHIELD FILTER TOWARD THE SHEATH, IT BECAME ENTANGLE WITH THE IMPLANTED STENT. ATTEMPTS WERE MADE TO ADVANCE THE RETRIEVAL CATHETER, BUT BECAUSE THE FILTER WAS ENTANGLED WITH THE STENT, IT COULD NOT BE COLLAPSED INTO THE RETRIEVAL CATHETER. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE FILTER AND STENT. NO ADDITIONAL TREATMENT WAS PROVIDED, AND THE PATIENT REMAINS IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10059898 ↗
• MalfunctionSep 17, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED INTERNAL CAROTID DE NOVO ARTERY THAT WAS 80% STENOSED. A 7-10/40 MM ACCULINK CAROTID STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION. DURING IMPLANTATION OF THE STENT, THERE WAS POOR VISIBILITY OF THE STENT. IT WAS NOT EASY TO CONFIRM IF THE STENT HAD BEEN FULLY DEPLOYED/IMPLANTED UNTIL FINAL CONTRAST WAS PERFORMED. THE LESION WAS STANDARD POST-DILATED WITH A 5 X 20 MM NON-ABBOTT BALLOON. THE FINAL RESULT WAS GOOD. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9077118 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY. ON (B)(6) 2018, A 4X20X135MM VIATRAC PLUS BALLOON CATHETER WAS BEING USED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 4 ATMOSPHERES. A 7-10X40MM ACCULINK STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT BEING GIVEN PLAVIX POST-PROCEDURE. THE PATIENT HAD A SEIZURE OVERNIGHT AND A COMPUTERIZED TOMOGRAPHIC ANGIOGRAPHY CONFIRMED THROMBOSIS IN THE ACCULINK STENT. THE PATIENT IS IN STABLE CONDITION AND IS GOING BACK TO THE CATH LAB ON (B)(6) 2018 TO HAVE A COVERED STENT IMPLANTED TO TREAT THE THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Seizures; Thrombosis

  MAUDE report 7265234 ↗
• MalfunctionOct 26, 2017Crack; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION, THE FLUSH PORT OF A .014 ACCULINK II SELF-EXPANDING STENT WAS NOTED TO BE CRACKED WHEN A SYRINGE WAS ATTACHED. THE DEVICE COULD THEREFORE NOT BE FLUSHED AND IT WAS NOT USED IN THE ANATOMY. IT WAS REPLACED WITH ANOTHER ACCULINK DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THERE WAS A LEAK COMING FROM THE CRACKED FLUSH PORT OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6982227 ↗