Acculink™ 1011343-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08717648076374), received between Apr 3, 2017 and Jul 30, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (14 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Mechanical Jam; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50089981 ↗
• MalfunctionJul 14, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, AND 90% STENOSED INTERNAL CAROTID ARTERY. AN ACCULINK 6-8/40 WAS INSERTED BUT FAILED AS THE STENT PARTIALLY DEPLOYED AS THERE WAS MECHANICAL ISSUE WITH THE THUMBSLIDE. THE STENT WAS REMOVED AND REPLACED WITH AN ACCULINK 8/40. HOWEVER, THE SAME FAILURE TO DEPLOY TO BE DEPLOY OCCURRED. THE STENT WAS REMOVED AND REPLACED WITH A DIFFERENT SIZE ACCULINK WAS INSERTED AND SUCCESSFULLY DEPLOYED. 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 25815436 ↗
• MalfunctionJul 6, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 94% STENOSIS. THE ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION BUT THE STENT COULD NOT BE DEPLOYED. THERE WAS NO PROBLEM WITH THE DEPLOYMENT MECHANISM. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718475 ↗
• MalfunctionJun 3, 2026Material Separation; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION, HEAVY TORTUOSITY AND 80% STENOSIS. THE ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE HANDLE WAS PULLED BACK; HOWEVER, THE STENT ONLY PARTIALLY DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW ACCCULINK SESS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374354 ↗
• MalfunctionMay 5, 2026Material Separation; Component Missing

  IT WAS REPORTED THAT PRIOR TO USE OF THE 6-8X40MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS), THE WHITE TIP [NOSE CONE] WAS NOTED TO BE MISSING. THEREFORE, THE SESS WAS NOT USED IN THE PROCEDURE. ANOTHER UNSPECIFIED STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084890 ↗
• MalfunctionMay 5, 2026Break; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE ACCULINK DEVICE MET RESISTANCE DURING ADVANCEMENT BUT WAS DELIVERED TO THE TARGET LESION IN THE MILDLY CALCIFIED/TORTUOUS INTERNAL CAROTID ARTERY. THERE WAS A FAILURE OF THE ACCULINK STENT TO DEPLOY AT THE TARGET. AFTER MULTIPLE ATTEMPTS, THE DEVICE WAS WITHDRAWN. THERE WAS NO FLOWERING, NOR PARTIAL STENT DEPLOYMENT; NO STENT EXPOSED. THE STENT REMAINED COMPLETELY WITHIN THE DEPLOYMENT SHEATH. A NEW ACCULINK DEVICE WAS USED, SUCCESSFULLY COMPLETING THE PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED. THE SHAFT OF THE RETURNED DEVICE WAS SEPARATED AT THE DISTAL END OF THE HANDLE SLIDER. THE CUSTOMER WAS NOT AWARE OF THIS SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083350 ↗
• MalfunctionFeb 20, 2026Break; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN INTERNAL CAROTID ARTERY. ONCE AT THE LESION, THE HANDLE SLIDE OF THE 6-8X40MM ACCULINK CAROTID SELF-EXPANDING STENT SYSTEM OVER A 0.14 GUIDEWIRE WAS PULLED; HOWEVER, THE STENT COMPLETELY FAILED TO DEPLOY. AN XACT CAROTID STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENTLY, RETURNED DEVICE ANALYSIS OBSERVED THE SHAFT WAS SEPARATED AT THE DISTAL END OF THE HANDLE SLIDER. THE SHAFT AT THE SEPARATION WAS BUNCHED AND THE HYPOTUBE WAS STILL INTACT HOLDING BOTH PIECES TOGETHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24404130 ↗
• MalfunctionOct 15, 2025Premature Activation; Deformation Due to Compressive Stress; Difficult to Advance; Premature Activation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6-8X40MM ACCULINK SELF-EXPANDING STENT SYSTEM THE STENT WAS OBSERVED TO BE EXPOSED AND NOT FLOWERED. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 23293988 ↗
• MalfunctionNov 20, 2024Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INTERNAL CAROTID ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 95% STENOSIS. THE ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE HANDLE WAS BROKEN AND THE STENT COMPLETELY FAILED TO DEPLOY. ANOTHER ACCULINK SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE SHAFT WAS BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735407 ↗
• MalfunctionMay 24, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL INTERNAL CAROTID ARTERY WITH 95% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE ACCULINK CAROTID STENT SYSTEM PARTIALLY DEPLOYED AND WAS REMOVED. ANOTHER ACCULINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 19393039 ↗
• MalfunctionDec 4, 2023Break; Mechanical Jam; Activation Failure; Break; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A 95% STENOSED LESION IN THE INTERNAL CAROTID ARTERY (ICA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 6-8X40MM ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED; HOWEVER, THE STENT FAILED TO DEPLOY BECAUSE THE THUMBSLIDE WAS STUCK. ANOTHER ACCULINK SESS WAS USED IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THAT THE HYPOTUBE WAS SEPARATED INSIDE THE HANDLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259135 ↗
• MalfunctionSep 15, 2022Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION OF A 6-8 X 40MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS) THAT SALINE LEAKED OUT OF THE SIDE OF THE FLUSHING PORT WHERE THE SYRINGE ATTACHES. THE SYRINGE CONNECTION WAS CONFIRMED AND NO CRACKS WERE OBSERVED ON THE SESS. THE SESS WAS NOT USED IN THE PROCEDURE AND WAS REPLACED WITH ANOTHER ACCULINK SESS. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND A BREAK IN THE SHAFT (NOT IN TWO PIECES). THE ACCOUNT REPORTED THEY WERE NOT AWARE OF THE BREAK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433569 ↗
• MalfunctionAug 16, 2022Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY, AND 80% STENOSIS. THE 6-8X40 MM ACCULINK CAROTID STENT SYSTEM WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS ATTEMPTED BUT THERE WAS RESISTANCE IN THE DELIVERY SYSTEM. THE STENT ONLY PARTIALLY DEPLOYED SO IT WAS REMOVED AND A NON-ABBOTT STENT 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 15237866 ↗
• MalfunctionAug 8, 2022Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CAROTID ARTERY. THE ACCULINK SELF EXPANDING STENT SYSTEM WAS INSERTED ON THE WIRE AND DURING ADVANCEMENT, RESISTANCE WAS NOTED, SO IT WAS BACKLOADED OFF THE WIRE. THE STENT SYSTEM DID NOT ENTER THE PATIENT. SOMETHING DID NOT FEEL RIGHT AND IT WAS NOTED THAT THE STENT WAS EXPOSED, SO IT WAS NOT USED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A SAME SIZED XACT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188494 ↗
• MalfunctionJun 3, 2022Break; Mechanical Jam; Activation Failure; Break; Mechanical Jam; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN THE LEFT INTERNAL CAROTID ARTERY. WHEN ATTEMPTING TO DEPLOY THE STENT, AFTER UNLOCKING THE LOCK, THE PULLBACK HANDLE DID NOT SLIDE BACK, AND THE STENT DID NOT DEPLOY. THE USER TRIED SO HARD TO DEPLOY THE CLIP THAT THE HANDLE BROKE APART. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596853 ↗
• MalfunctionFeb 17, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE, THE PHYSICIAN OPENED THE CARTON OF THE DEVICE AND NOTICED THAT THE INNER POUCH WAS TORN, RESULTING IN UNSTERILE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER SAME SIZE ACCULINK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553180 ↗
• MalfunctionFeb 8, 2022Break; Difficult to Flush; Break; Difficult to Flush

  IT WAS REPORTED THAT DURING UNPACKING OF AN ACCULINK, IT WAS NOTED THAT THE HUB WAS CRACKED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE 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 13481924 ↗
• MalfunctionJul 21, 2021Material Separation; Difficult to Advance; Activation Failure; Material Separation; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INTERNAL CAROTID ARTERY WITH 90% STENOSIS. THE 6-8X40 MM ACCULINK CAROTID STENT SYSTEM WAS ADVANCED WITH RESISTANCE NOTED WITH THE GUIDING CATHETER. THE STENT WAS ATTEMPTED TO BE RELEASED BUT THE SHAFT OF THE DELIVERY SYSTEM WAS NOTED TO BE SEPARATED OUTSIDE OF THE PATIENT DURING THE PROCEDURE. THE DISTAL PORTION OF THE SEPARATION WAS SIMPLY WITHDRAWN AND THE STENT WAS RELEASED OUTSIDE OF THE ANATOMY. A NEW ACCULINK CAROTID STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 12207668 ↗
• InjuryJul 14, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INTERNAL CAROTID ARTERY. PRIOR TO IMPLANTATION OF THE 6-8X40 MM ACCULINK STENT, THE SELF-EXPANDING STENT SYSTEM (SESS) WAS CHECKED TO CONFIRM THAT THE STENT WAS INTACT. THE ACCULINK SESS WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND THE STENT WAS DEPLOYED. DURING REMOVAL OF THE DELIVERY SYSTEM, IT WAS FOUND THAT THE SHAFT OF THE DELIVERY SYSTEM HAD SEPARATED. THE SEPARATED PORTION WAS BLOCKING BLOOD FLOW AND THERE WAS THE POTENTIAL TO CAUSE A CEREBRAL INFARCTION. THE EMBOLIC PROTECTION SYSTEM RETRIEVAL CATHETER WAS IMMEDIATELY ADVANCED TO THE EMBOLIC PROTECTION DEVICE AND THE FILTER AND THE BROKEN PORTION OF THE STENT DELIVERY SYSTEM WERE ABLE TO BE PULLED INTO THE GUIDING CATHETER AND REMOVED. THERE WAS SOME RESISTANCE NOTED WITH THE GUIDE CATHETER DURING REMOVAL. NO ABNORMALITIES WERE SEEN ON ANGIOGRAPHY ONCE EVERYTHING WAS REMOVED. THE PATIENT SHOWED NO ABNORMAL SYMPTOMS WHEN CHECKED ON THE FOLLOWING TWO DAYS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12170714 ↗
• MalfunctionJun 29, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED, THAT THE PROCEDURE WAS TO TREAT THE LEFT INTERNAL CAROTID ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 6-8X40 MM ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED, THE STENT WAS IMPLANTED WITH NO ISSUES NOTED. AND THE STENT DELIVERY SYSTEM WAS REMOVED WITH SOME RESISTANCE NOTED, WITH THE GUIDE CATHETER. IN PROCESS OF RETRIEVING THE FILTER OF THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS), IT WAS NOTED, THAT THE TIP OF THE STENT DELIVERY SYSTEM HAD BROKEN OFF AND WAS ABLE TO BE VISUALIZED. THE RETRIEVAL CATHETER WAS STUCK, LIKELY ON THE SEPARATED TIP. AND THE GUIDING CATHETER WAS ADVANCED OVER THE RETRIEVAL CATHETER, ALLOWING THE FILTER AND THE SEPARATED TIP OF THE DELIVERY SYSTEM TO BE WITHDRAWN TOGETHER AS A SYSTEM. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE EMBOSHIELD NAV6 AND ACCULINK SESS WERE ADVANCED WITHOUT ISSUE. THE ACCULINK DELIVERY SYSTEM WAS NOT CHECKED IMMEDIATELY, ONCE IT CAME OUT OF THE PATIENT. THE RETRIEVAL CATHETER OF THE EMBOSHIELD NAV6 WAS ADVANCED WITHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085655 ↗
• MalfunctionMay 25, 2021Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED LESION IN THE INTERNAL CAROTID ARTERY. A 6-8X40MM .014 ACCULINK RX SELF-EXPANDING STENT SYSTEM (SESS) FAILED TO DEPLOY WHILE IN THE PATIENT. THE SESS WAS REMOVED AND ONCE OUTSIDE THE PATIENT IT COULD ONLY BE RELEASED ONE THIRD OF THE WAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURN DEVICE ANALYSIS IDENTIFIED THAT THE HANDLE WAS UNLOCKED, THE HANDLE SLIDER WAS MOVING FREELY, AND THE STENT DID NOT DEPLOY. IT WAS OBSERVED THAT THE SHAFT WAS SEPARATED 6.8CM PROXIMAL TO THE DISTAL END OF THE STRAIN RELIEF. THE HYPOTUBE WAS STILL INTACT HOLDING BOTH PIECES TOGETHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882009 ↗
• MalfunctionMar 29, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING PREP, AFTER A 6-8X40MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS) WAS REMOVED FROM ITS TRAY, THE STENT WAS SLIGHTLY EXPOSED BUT NOT FLOWERED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A 6-8X40MM XACT STENT WAS USED TO SUCCESSFULLY COMPLETE 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 11585675 ↗
• InjuryFeb 22, 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 AN EMBOLIZED RIGHT CAROTID ARTERY. THE PATIENT HAD HEMIPLEGIC SYMPTOMS WHICH WERE IMPROVED WITH THE IMPLANTATION OF A 6X8MM RX .014 ACCULINK STENT. TWO DAYS LATER, ROUTING POSTOPERATIVE REEXAMINATION OF CAROTID ARTERY WITH COLOR DOPPLER ULTRASOUND SHOWED STENT OCCLUSION WITH THROMBOSIS. EMERGENCY ARTERIAL EMBOLECTOMY, BALLOON DILATATION, AND STENT IMPLANTATION WERE IMMEDIATELY PERFORMED. THE EVENT WAS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11362995 ↗
• InjuryJun 2, 2020Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY STENOSED LESION, IN THE RIGHT COMMON FEMORAL ARTERY, GRAFT, WITH A VERY HIGH BIFURCATION. DURING ADVANCEMENT OF THE 6-8X40 MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS), RESISTANCE WAS FELT WITH THE ANATOMY AND THE DISTAL SHAFT SEPARATED. RESISTANCE WAS FELT DURING WITHDRAWAL, REQUIRING FORCE. THE SEPARATED SEGMENT WAS SNARED. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10112456 ↗
• MalfunctionOct 7, 2019Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Twisted/Bent; Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO BE PERFORMED TO TREAT A LESION IN THE RIGHT INTERNAL CAROTID ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. A 6.0X40 MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCING, BUT RESISTANCE MET WITH THE TORTUOSITY CAUSING THE DELIVERY CATHETER SHEATH TO BECOME KINKED. THE SESS COULD NOT CROSS THE TARGET LESION AND THEN THE SHEATH BECAME BENT. THEREFORE, THE SESS WAS REMOVED FROM THE PATIENT; HOWEVER, AFTER THE SESS WAS REMOVED, THE SHEATH BECAME SEPARATED FROM THE DEVICE. THE PROCEDURE WAS ABORTED AND RESCHEDULED TO BE PERFORMED AT A LATER DATE. THE PATIENT IS STABLE. 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 9163725 ↗