XACT™ 82086-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648010224), received between May 3, 2017 and Apr 22, 2026 — classified as 1 death, 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Difficult to Flush; Difficult to Insert

  IT WAS REPORTED THAT DURING PREPARATION, IT WAS FOUND THAT THE TIP OF A 9X7 MM XACT STENT WAS BLOCKED AND WAS UNABLE TO BE FLUSHED. IT WAS ALSO UNABLE TO BE ADVANCED ONTO THE 0.014 INCH GUIDEWIRE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OF THE RETURNED DEVICE NOTED A COMPLETE BLOCKAGE AT THE DISTAL END OF THE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958432 ↗
• MalfunctionJan 5, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS DEPLOYED. THE XACT SELF EXPANDING STENT SYSTEM (SESS) RELEASED THE STENT BY 1/3 BUT THE REMAINING PORTION COULD NOT BE RELEASED. THE 8FR GUIDING CATHETER THAT WAS ALREADY INSIDE THE ANATOMY WAS USED TO RETRACT THE STENT AND THE EMBOSHIELD NAV6 EPS FILTER WAS REMOVED WHEN THE STENT WAS REMOVED. ANOTHER SAME SIZE DEVICE 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 23964977 ↗
• MalfunctionNov 13, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, TORTUOUS LEFT CAROTID ARTERY THAT IS 80% STENOSED. A 6FR SHORT SHEATH WAS USED FOR ACCESS AND DIAGNOSTIC IMAGES WERE OBTAINED. THE SHEATH WAS EXCHANGED FOR A 6FR 90CM SHEATH. A EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM WAS ADVANCED WITH RESISTANCE FELT WITH ANATOMY; HOWEVER, DEPLOYED SUCCESSFULLY. THE LESION WAS PRE-DILATED WITH A 4X20MM VIATRAC BALLOON AND A 9TX40X136 XACT CAROTID STENT SYSTEM WAS ATTEMPTED TO BE ADVANCED; HOWEVER COULD NOT ADVANCE DUE TO ANATOMY. A 5.0X30MM VIATRAC BALLOON WAS USED TO DILATE THE LESION AGAIN WITH SUCCESSFUL INFLATION AND THE XACT WAS ATTEMPTED TO ADVANCE VARIETY OF WAYS INCLUDING WITH AN UNSPECIFIED BUDDY WIRE AND MICRO CATHETER; HOWEVER, WAS UNSUCCESSFUL DUE TO ANATOMY. THEN AN UNSPECIFIED ACCULINK STENT SYSTEM ALONG WITH AN UNSPECIFIED SUPPORT CATHETER WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE XACT WAS ADVANCED ONE MORE TIME AND WAS ABLE TO CROSS THE LESION; HOWEVER, RESISTANCE WAS MET WITH CALCIUM AND BECAME DIFFICULT TO MANEUVER. DURING REMOVAL THE STENT WAS STUCK IN THE SHEATH AND AND TO HOLD THE SHEATH IN THE GROIN WHILE THE STENT WAS FORCI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547461 ↗
• MalfunctionJan 29, 2025Unsealed Device Packaging; Component Missing; Unsealed Device Packaging; Component Missing

  IT WAS REPORTED THAT WHEN THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS REMOVED FROM THE CHIPBOARD BOX, THE DEVICE WAS FOUND TO BE IN THE DISPENSER HOOP BUT THERE WAS NO POUCH. THEREFORE THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW XACT SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269803 ↗
• InjuryMar 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A XACT STENT WAS IMPLANTED IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED INTERNAL CAROTID ARTERY. DURING A FOLLOW UP ON (B)(6) 2024, IT WAS NOTED THAT THE STENT HAD SEPARATED INTO TWO PIECES. REPORTEDLY, THE PATIENT WAS NOT STIMULATED BY EXTERNAL FORCES AND WAS ABLE TO MOVE NORMALLY. THE PHYSICIAN PLANS TO PERFORM SURGERY TO REMOVE THE STENT AND THE PATIENT HAS BEEN TRANSFERRED TO AN EXTERNAL HOSPITAL FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888362 ↗
• MalfunctionJan 13, 2023Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 70% STENOSED LESION IN THE INTERNAL CAROTID ARTERY. A 9TX40MMX136 XACT CAROTID SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE THUMBWHEEL BECAME STUCK AND COULD NOT BE ROTATED, CAUSING THE SESS TO BECOME EXPOSED BUT NOT FLOWERED OR DEPLOYED. THE STENT WAS COMPLETELY WITHIN THE DEPLOYMENT SHEATH AND EASILY REMOVED WITH THE DELIVERY CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE STENT WAS INTENTIONALLY RELEASED OUTSIDE OF THE ANATOMY WITHOUT ISSUE. A NEW, SAME SIZE XACT SESS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162421 ↗
• MalfunctionDec 27, 2022Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LEFT INTERNAL CAROTID ARTERY. THE 9TX40X136 XACT SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, MET RESISTANCE WITH THE UNSPECIFIED GUIDE WIRE. THE DISTAL END OF THE STENT BECAME PARTIALLY FLOWERED. THE XACT SESS WAS REMOVED AND A SECOND 9TX40X136 XACT SESS WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE SESS WAS REMOVED AND AN UNSPECIFIED ACCULINK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 16055111 ↗
• InjuryNov 26, 2021Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2021 TO TREAT A TORTUOUS VESSEL IN THE LEFT CAROTID ARTERY WITH A CERTAIN INCLUDED ANGLE, AND THE NECK RANGE OF MOTION AT THE STENT SITE WAS LARGE. AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) FILTER WAS OPENED AND AN UNSPECIFIED BALLOON WAS USED FOR DILATATION WITH THE FILTER. THE 9.0X40MM XACT SELF-EXPANDING STENT SYSTEM (SESS) DIDN'T FULLY EXPAND WHEN THE STENT WAS DEPLOYED AND AN ADDITIONAL BALLOON WAS USED TO FURTHER DEPLOY THE STENT AND IMPLANT IT IN THE VESSEL. THE PATIENT WAS RE-EXAMINED ON (B)(6) 2021 AS A ROUTINE PROCEDURE 2-3 MONTHS AFTER OPERATION AND THAT'S WHEN THE STENT WAS NOTED TO BE SEPARATED IN TWO PIECES. THE STENT REMAINS IMPLANTED AND NO TREATMENT WAS PERFORMED. THE PATIENT'S BLOOD FLOW IS FINE HAVING NO EFFECT ON THE PATIENT. 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 12879212 ↗
• MalfunctionApr 5, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING PREPARATION OF AN XACT SELF-EXPANDING STENT SYSTEM (SESS), THE SESS WAS REMOVED FROM THE PACKAGING AND IT WAS NOTED THAT THE STENT WAS EXPOSED BUT NOT FLOWERING. THE DEVICE WAS DISCARDED. 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 11615687 ↗
• InjuryDec 16, 2019Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT INTERNAL CAROTID ARTERY. IN (B)(6) 2017, AN XACT STENT WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2019, THE PATIENT THEN EXPERIENCED VISION LOSS. THEREFORE, THE PATIENT WAS SENT FOR TREATMENT THE SAME DAY. VIA ANGIOGRAPHY, IT WAS NOTED THAT THE XACT STENT WAS FRACTURED (BUT NOT IN TWO PIECES). DURING PREPARATION OF AN EMBOSHIELD NAV6, IT WAS DIFFICULT TO LOAD THE FILTER ONTO THE DELIVERY CATHETER (DC) POD. HOWEVER, AFTER SOME MANIPULATION THE FILTER WAS ABLE TO LOAD ONTO THE DC POD SUCCESSFULLY AND WAS USED WITHOUT ISSUE. THEN THREE UNSPECIFIED STENTS WERE USED TO SUCCESSFULLY TREAT THE FRACTURED STENT. THE PATIENT IS FINE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 9475167 ↗
• DeathDec 13, 2019Adverse 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 90% STENOSED LEFT INTERNAL CAROTID ARTERY. THE CAROTID LESION WAS NOTED DURING A CORONARY ANGIOGRAM, AND THIS PROCEDURE WAS PERFORMED TO TREAT BOTH CAROTID AND CORONARY ARTERIES. THE CAROTID ARTERY WAS CHOSEN FIRST. A 4X30MM VIATRAC 14 BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION. AN EMBOSHIELD NAV6 WAS USED ALONG WITH A 9X40MM XACT SELF-EXPANDING STENT SYSTEM (SESS). THE STENT WAS IMPLANTED SUCCESSFULLY. A 5X30MM VIATRAC 14 BDC WAS USED FOR POST-DILATATION, AND A PROGLIDE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DEVELOPED ATRIAL FLUTTER, SO DOPAMINE WAS GIVEN AS TREATMENT. THE PATIENT WAS STABLE; HOWEVER, THE PATIENT WENT INTO CARDIAC ARREST. CPR WAS PERFORMED, BUT THE PATIENT EXPIRED 30 TO 45 MINUTES AFTER THE PROCEDURE. THERE WERE NO DEVICE ISSUES NOTED. IN THE OPINION OF THE PHYSICIAN, PATIENT DEATH WAS NOT RELATED TO ANY OF THE DEVICES USED IN THE CAROTID PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Flutter; Cardiac Arrest

  MAUDE report 9466803 ↗
• InjuryOct 25, 2019Adverse 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. A XACT CAROTID STENT SYSTEM WAS USED FOR THIS PROCEDURE AND DEPLOYED WITHOUT ISSUE FOLLOWING THE INSTRUCTIONS FOR USE (IFU). AN UNSPECIFIED BALLOON WAS USED FOR STANDARD POST-DILATATION OF THE LESION. HOWEVER THE PATIENT STARTED TO FEEL DISCOMFORT. AT THIS POINT, THE FILTER WAS RETRIEVED AND NEUROLOGICAL, VISUAL, AND VERBAL TESTS WERE DONE. IT WAS NOTED THAT THE PATIENT'S LEFT EYE DROOPED AND VISION CHANGES OCCURRED, WHEN THE PATIENT SMILED THE FACE STARTED TO DROOP, SPEECH WAS SLURRED; THE PATIENT HAD A STROKE. TISSUE PLASMINOGEN ACTIVATOR MEDICATION WAS PROVIDED TO THE PATIENT IMMEDIATELY. THERE IS NO DETERMINATION ON WHAT CAUSED THE STROKE. PATIENT IS DOING WELL AND RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Stroke/CVA

  MAUDE report 9239746 ↗
• InjuryAug 8, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, AN XACT STENT WAS SUCCESSFULLY IMPLANTED, WITHOUT ANY DEVICE ISSUES, IN THE RIGHT INTERNAL CAROTID, ACROSS A BIFURCATION. ON (B)(6) 2019, THE PATIENT PRESENTED WITH TRANSIENT ISCHEMIC SYMPTOMS AND SYNCOPE. IMAGING WAS PERFORMED AND THE XACT STENT HAD PARTIALLY FRACTURED. THE PHYSICIAN IS UNSURE IF THE TIA SYMPTOMS AND SYNCOPE ARE RELATED TO THE XACT STENT OR IF THEY ARE RELATED TO THE PATIENT'S PRE-EXISTING ATRIAL FIBRILLATION. THERE WAS STILL GOOD BLOOD FLOW THROUGH THE STENT SO NO TREATMENT WAS DEEMED NECESSARY. THE EVENT DID NOT REQUIRED HOSPITALIZATION AND NO TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Syncope; Transient Ischemic Attack

  MAUDE report 8876165 ↗
• MalfunctionOct 25, 2017Inaccurate Delivery; Physical Resistance

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MODERATE CALCIFICATION AND MILD TORTUOSITY IN THE INTERNAL CAROTID ARTERY. AN ATTEMPT WAS MADE TO DIRECT STENT WITH A 9 X 40 MM XACT STENT. THE XACT STENT SYSTEM WAS ADVANCED, BUT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. THE PHYSICIAN ATTEMPTED MULTIPLE TIMES PUSHING THE DEVICE, BUT WAS UNSUCCESSFUL AND THE VESSEL WENT INTO SPASM. THE XACT WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE, AND A 4.0 X 20 MM VIATRAC BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. THEN, THE XACT WAS RE-ADVANCED BUT STILL COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND WAS WITHDRAWN FROM THE ANATOMY A SECOND TIME. ONCE AGAIN, DILATATION WAS PERFORMED USING A 5.0 X 20 MM VIATRAC BALLOON CATHETER. THE XACT WAS ADVANCED A THIRD TIME; HOWEVER, VESSEL SPASM OCCURRED AGAIN. THE PATIENT WAS GIVEN MEDICATION FOR THE VESSEL SPASM. THE XACT WAS ADVANCED TO THE TARGET LESION, BUT DURING DEPLOYMENT THE STENT JUMPED DISTALLY. THEREFORE, A 9 X 30 MM XACT WAS ADVANCED WITHOUT ISSUE AND IMPLANTED PROXIMALLY WITH A 5 MM OVERLAP OF THE 9 X 40 MM XACT STENT TO SUCCESSFULLY COVER THE REMAINING PART OF THE LESION. POST DILATATION WAS PERFORMED WITH

  Patient problems: Vasoconstriction

  MAUDE report 6977628 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. AN EMBOSHIELD NAV6 WAS USED FOR PROTECTION AND A 9TX40X136 CM XACT STENT WAS DEPLOYED SUCCESSFULLY IN THE LESION. THE PROCEDURE WENT AS PLANNED WITHOUT ANY COMPLICATIONS OR ANY NOTED DEVICE ISSUES; HOWEVER, POST-PROCEDURE, WHEN TALKING WITH THE PATIENT, IT WAS OBSERVED THAT HE HAD DIFFICULTY TALKING AND A HARD TIME MOVING HIS RIGHT ARM. THE PATIENT WAS SENT TO A DIFFERENT HOSPITAL AND A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH DID NOT REVEAL ANYTHING OUT OF THE ORDINARY. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED A DISTAL M2 INFARCT. IT CANNOT BE DETERMINED AT WHAT POINT DURING THE PROCEDURE THE INFARCT TOOK PLACE. NO TREATMENT WAS PERFORMED AND AS OF (B)(6) 2017, THE PATIENT IS REPORTED TO BE DOING WELL AND RECOVERING IN HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 6838134 ↗
• InjuryJul 27, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE, ON (B)(6) 2017, WAS TO TREAT THE RIGHT INTERNAL CAROTID ARTERY. THE EMBOSHIELD NAV6 WAS PLACED FOLLOWED BY SUCCESSFUL IMPLANTATION OF THE 9-7X40 XACT STENT. AFTER THE XACT STENT WAS IMPLANTED, THERE WAS NO FLOW DISTAL TO THE STENT AND THE PATIENT WAS NOTED TO HAVE SLURRED SPEECH. MEDICATION (TPA) WAS ADMINISTERED TO BREAK UP ANY POTENTIAL CLOT AND AN ASPIRATION CATHETER WAS USED TO REMOVE DEBRIS FROM THE EMBOSHIELD NAV6. THE FILTER WAS THEN REMOVED AND DISTAL FLOW WAS RESTORED. THE SLURRED SPEECH IMPROVED, BUT WAS STILL PRESENT. VISUAL EXAMINATION OF THE FILTER IDENTIFIED THE DEBRIS THAT WAS IN THE FILTER APPEARED TO BE CALCIUM RATHER THAN CLOT. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT FOR A CT SCAN. AN INTRACRANIAL BLEED WAS NOTED. ON AN UNKNOWN DATE, THE PATIENT WAS UNABLE TO SPEAK AND WAS IN A VEGETATIVE STATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intracranial Hemorrhage; Neurological Deficit/Dysfunction

  MAUDE report 6749399 ↗
• MalfunctionMay 3, 2017Partial Blockage; Difficult To Position

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED INTERNAL CAROTID ARTERY. A BAREWIRE WOULD NOT ADVANCE THROUGH THE GUIDE WIRE LUMEN OF A 9.0 X 40 MM XACT SELF-EXPANDING STENT SYSTEM. A NEW 9.0 X 40 MM XACT WAS GOING TO BE USED; HOWEVER, THE GUIDE WIRE COULD NOT ADVANCE THROUGH THE LUMEN OF THE SECOND XACT EITHER. OUTSIDE THE ANATOMY A COMMAND GUIDE WIRE ALSO COULD NOT ADVANCE THROUGH THE INNER MEMBER OF THE XACT STENT SYSTEMS. IT APPEARED THAT THE GUIDE WIRE LUMEN OF THE TWO XACT DELIVERY SYSTEMS WAS PLUGGED. A NON-ABBOTT STENT DELIVERY SYSTEM WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6541881 ↗
• MalfunctionMay 3, 2017Partial Blockage; Difficult To Position

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED INTERNAL CAROTID ARTERY. A BAREWIRE WOULD NOT ADVANCE THROUGH THE GUIDE WIRE LUMEN OF A 9.0 X 40 MM XACT SELF-EXPANDING STENT SYSTEM. A NEW 9.0 X 40 MM XACT WAS GOING TO BE USED; HOWEVER, THE GUIDE WIRE COULD NOT ADVANCE THROUGH THE LUMEN OF THE SECOND XACT EITHER. OUTSIDE THE ANATOMY A COMMAND GUIDE WIRE ALSO COULD NOT ADVANCE THROUGH THE INNER MEMBER OF THE XACT STENT SYSTEMS. IT APPEARED THAT THE GUIDE WIRE LUMEN OF THE TWO XACT DELIVERY SYSTEMS WAS PLUGGED. A NON-ABBOTT STENT DELIVERY SYSTEM WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6541864 ↗