Axium Detachable Coil System QC-3-6-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00847536037694), received between Jan 11, 2023 and Mar 18, 2026 — classified as 1 injury, 18 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K081465); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED ON THE ANTERIOR COMMUNICATING ARTERY  WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY WAS TREATED WITH COIL EMBOLIZATION. AFTER THE MICROCATHETER WAS POSITIONED INTRAOPERATIVELY, THE QC-3-6-3D COIL WAS SELECTED FOR DELIVERY AND FILLING. ONCE THE COIL WAS FULLY FILLED WITHIN THE ANEURYSM, THE DETACHMENT ZONE OF THE PUSHER ROD WAS BROKEN AND PULLED OUT, BUT FLUOROSCOPIC OBSERVATION SHOWED THAT THE COIL HAD NOT DETACHED. THE COIL WAS THEN REMOVED AND REPLACED WITH ANOTHER COIL TO CONTINUE THE PROCEDURE. THE QC-3-6-3D COIL WAS RETURNED FOR EVALUATION. NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH MANUAL DETACHMENT, THEY DID NOT TRY TO USE ANOTHER INSTANT DETACHER. A MANUAL ATTEMPT  AT DETACHMENT VIA HYPO TUBE WAS USED AND WAS ATTEMPTED 2 TIMES. ALL DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626958 ↗
• MalfunctionNov 25, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT FOR THE TREATMENT OF A CONGENITAL VASCULAR FISTULA, QC COIL WAS USED FOR FILLING. THE ACCESS AND COIL WAS ROUTINELY HYDRATED AND FLUSHED. A QC-10-30-3D COIL WAS SELECTED TO FORM A HOOP AND FRAME COULD NOT BE PUSHED OUT OF THE ECHELON 10 MICROCATHETER. A NEW QC-10-30-3D COIL WAS THEN SELECTED, WHICH SUCCESSFULLY PUSHED OUT AND FORM A HOOP. WHEN THE QC-3-6-3D COIL WAS GRADUALLY FILLED, IT COULD NOT BE PUSHED OUT OF THE ECHELON 10 MICROCATHETER. ADJUSTMENTS DID NOT IMPROVE THE SITUATION. THE COIL WAS REMOVED AND REPLACED WITH NEW QC-2-4-3D COIL, THE SAME PROBLEM STILL OCCURRED AND IT COULD NOT BE PUSHED OUT OF THE MICROCATHETER. THE QC-2-8-2D COIL WAS THEN SELECTED, WHICH WAS ABLE TO PUSH OUT AND CONTINUE THE EMBOLIZATION. SUBSEQUENT COILS COULD BE USED NORMALLY TO COMPLETE THE PROCEDURE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF COMPLEX NEUROVASCULAR ABNORMALITIES. ABNORMALITY WAS NOT LOCATED IN THE ELOQUENT REGION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646452 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATION WAS FOR AN INTRACRANIAL ANEURYSM EMBOLIZATION. THE RESISTANCE DURING THE MICROCATHETER DELIVERY OF THE SPRING COIL WAS LARGE AND IT WAS DIFFICULT TO ADVANCE. WHEN WITHDRAWING, THE SPRING COIL WAS DETACHED BY ITSELF. THE MICROCATHETER WAS WITHDRAWN TO REMOVE THE SPRING COIL, AND THEN IT WAS REPLACED WITH A NEW SPRING COIL FOR EMBOLIZATION. THE OPERATION WAS SUCCESSFULLY COMPLETED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506116 ↗
• MalfunctionJun 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM QC COIL COULD NOT BE PUSHED INTO THE MICROCATHETER. DURING ANEURYSM SURGERY, RESISTANCE WAS ENCOUNTERED WHEN PUSHING THE COIL INTO THE ECHELON 10 MICROCATHETER. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE PROXIMAL SECTION OF THE CATHETER. THERE WAS NO CATHETER OR COIL DAMAGE OBSERVED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER USED WAS AN ECHELON 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170978 ↗
• MalfunctionMay 20, 2025Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT ONE AXIUM COIL PREMATURELY DETACHED AND ANOTHER ENCOUNTERED RESISTANCE IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED RIGHT ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION, IT WAS FOUND THAT THE SPRING COIL (QC-3-6-3D) AUTOMATICALLY DETACHED IN THE MICROCATHETER DURING THE SPRING COIL PUSHING PROCESS. THE MICROCATHETER WAS WITHDRAWN, THE SPRING COIL WAS PUSHED OUT AND IT WAS REPLACED WITH A NEW ONE, AND THE NEW ONE WAS DELIVERED NORMALLY. IT WAS ALSO REPORTED THAT THE SPRING COIL (QC-4-12-3D) COULD NOT BE PUSHED OUT OF THE INTRODUCTION SHEATH. THE DELIVERY ROD WAS FOUND TO BE DAMAGED. IT WAS REPLACED WITH A NEW COIL AND PUSHED NORMALLY. ADDITIONALLY, BOTH COILS WERE REPORTED TO BE USED AFTER THE USE BY DATE. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050955 ↗
• MalfunctionMay 15, 2025Stretched; Separation Failure; Stretched; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PROCEDURE WAS COMPLETED BY REPLACING THE NEW QC COIL TO COMPLETE THE OPERATION. THE CAUSE OF THE NON-DETACHMENT/STRETCH WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THEY WERE NOT USING THE INSTANT DETACHER. THERE WAS ONE ATTEMPT TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027413 ↗
• MalfunctionMar 31, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATION OCCURRING WAS A WHOLE BRAIN ANGIOGRAPHY AND INTRACRANIAL ANEURYSM EMBOLIZATION. THE LOCATION OF THE INTRACRANIAL ANEURYSM WAS DETERMINED BY ANGIOGRAPHY. THE 6F SHORT SHEATH, THE DISTAL ACCESS CATHETER, THE GUIDEWIRE SYNCHRO-14, THE ECHELON 145-5091-150 MICROCATHETER, AND THE DETACHABLE SPRING COIL WERE SELECTED. AFTER THE PREPARATION WORK WAS COMPLETED, THE ECHELON 145-5091-150 MICROCATHETER WAS RINSED AND MOISTENED WITH NORMAL SALINE. AFTER THE GUIDEWIRE WAS PUT IN PLACE, THE DETACHABLE SPRING COIL QC-3-6-3D WAS DELIVERED INTO THE ANEURYSM TO FORM A HOOP. THE EFFECT WAS SATISFACTORY. THE DETACHABLE SPRING COIL WAS DETACHED. WHEN THE SURGEON DETACHED IT, IT WAS FOUND THAT ALL THE DETACHMENT WIRES WERE PULLED OUT. UNDER ANGIOGRAPHY, IT WAS FOUND THAT THE DETACHABLE SPRING COIL COULD NOT BE DETACHED. FOR SAFETY REASONS, THE SPRING COIL WAS PULLED OUT AGAIN AND ANOTHER DETACHABLE SPRING COIL WAS USED INSTEAD FOR EMBOLIZATION. AFTER THE OPERATION, THE SURGEON REPORTED THAT THE DETACHABLE SPRING COIL COULD NOT BE SUCCESSFULLY DETACHED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730560 ↗
• MalfunctionMar 17, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620217 ↗
• MalfunctionMar 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO DETACHMENT ATTEMPTS MADE WITH EITHER THE INSTANT DETACHER OR THE MANUAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575750 ↗
• MalfunctionJan 2, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE TREATMENT OF A RUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY USING A BARE AXIUM 3D COIL, THE COIL BECAME STUCK IN THE SHEATH. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 4 MILLIMETERS AND A NECK DIAMETER OF 1 MILLIMETER, WITH MODERATE VESSEL TORTUOSITY AND NORMAL BLOOD FLOW. THE PROCEDURE INVOLVED THE USE OF A MICROCATHETER, SPECIFICALLY AN ECHELON. THE DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE COIL EXPERIENCED RESISTANCE AND BECAME STUCK IN THE SHEATH. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL ACCIDENTALLY BROKE DURING THE PROCEDURE, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063992 ↗
• MalfunctionJun 17, 2024Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WERE FOUND STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT INTRACRANIAL ANEURYSM EMBOLIZATION WAS PERFORMED. AFTER THE MICROCATHETER WAS IN PLACE, THE DETACHABLE SPRING COIL QC-3-6-3D WAS SELECTED FOR FILLING. THE SPRING COIL WAS STRETCHED, AND IT WAS REPLACED WITH ANOTHER SPRING COIL AND FILLED SMOOTHLY, AND THEN FILLED. FINALLY, THE APB-1.5-4-3D-ES SPRING COIL WAS SELECTED TO FILL THE TUMOR NECK, THE TAIL END OF THE SPRING COIL WAS STRETCHED, AND IT WAS REPLACED WITH ANOTHER SPRING COIL OF THE SAME MODEL TO SUCCESSFULLY COMPLETE THE SURGERY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554182 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING ORIGIN ARTERY WITH A MAX DIAMETER OF 4.6MM AND A 1.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE SURGERY, THERE WAS GREAT RESISTANCE WHEN DELIVERING THE COIL THROUGH THE MICROCATHETER, AND ACCIDENTAL DETACHMENT OCCURRED BEFORE IT FULLY ENTERED THE SAC. THE ENTIRE SYSTEM TOGETHER WITH THE MICROCATHETER AND THE INTERMEDIATE CATHETER WERE REMOVED FROM THE BODY. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES AND DID NOT ATTEMPT TO DETACH THE COIL. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.  ANCILLARY DEVICES INCLUDE A SL-10 AND ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349877 ↗
• InjuryApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE HAD BEEN NO ATTEMPT MADE TO DETACH THE COIL. IT REMAINS IN THE PATIENT AND WAS ULTIMATELY IMPLANTED AT THE INTENDED LOCATION. FIBRINOGEN MEDICATION WAS USED TO ADDRESS THE REPORTED INFARCTION. POST-OPERATIVELY, THE PATIENT WAS AWAKE AND RESPONDING WELL BUT HAS PARALYSIS OF THE LEFT LOWER EXTREMITY (LLE).

  Patient problems: Foreign Body In Patient; Ischemia Stroke; Ventilator Dependent

  MAUDE report 19215970 ↗
• MalfunctionApr 15, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY C7 SEGMENT WITH A MAX DIAMETER OF 6.3 MM AND A 3.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM SPRING COIL COULD NOT BE DETACHED. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE INSTANT DETACHER WAS UNUSED. THE PHYSICIAN DID NOT USE ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT MADE TO DETACH THE COIL VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104341 ↗
• MalfunctionJan 12, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502781 ↗
• MalfunctionOct 11, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS BEING USED IN AN ANIMAL GOOD LABORATORY PRACTICE STUDY, AND NO PATIENT WAS HARMED IN THE PROCEDURE. THE AXIUM COIL BROKEN IN HALF WHILE IT WAS HALFWAY OUTSIDE OF THE MICROCATHETER DURING DELIVERY OF THE COIL. THERE WAS NO HARM TO THE ANIMAL, AND THE HALF OF THE COIL OUTSIDE OF THE MICROCATHETER COIL PACK WAS PUSHED INTO THE COIL PACK BY THE PROXIMAL END OF THE PUSHER. THE ANIMAL WAS LATER SACRIFICED AS PER PROTOCOL FOR HISTOLOGY ANALYSIS. THE COIL WAS NEVER DETACHED, AND THE PUSHER AND PART OF THE BROKEN COIL WAS REMOVED AND KEPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916063 ↗
• MalfunctionSep 18, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO COIL NON-DETACHMENT, IT DEPLOYED NORMALLY. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769965 ↗
• MalfunctionAug 28, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE AXIUM COIL DIDN¿T GET DETACHED AFTER USING THE MANUAL METHOD OR INSTANT DETACHER. PRIOR TO COIL NON-DETACHMENT THERE WERE NO ISSUES ENCOUNTERED. THERE WAS PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17636753 ↗
• MalfunctionJan 11, 2023Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED C7 ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PATIENT HAD AN ANEURYSM OF THE TERMINAL INTERNAL CAROTID ARTERY. 6FNAVIEN INTERMEDIATE CATHETER AS SUPPORT. THE REBAR WITH THE GUIDANCE OF THE GUIDEWIRE IN PLACE ENTERED INTO THE DISTAL BLOOD VESSELS RESPECTIVELY. ECHELON MICROCATHETER WITH THE GUIDANCE OF THE GUIDEWIRE IN PLACE ENTERED TO ANEURYSMS. SELECTED QC-3-6-3D TO FORM A HOOP AND DEPLOYED THE SAB-4-20 STENT. DURING THE PROCESS OF FORMING A HOOP, IT WAS FOUND THAT THE DEPLOYMENT AND RECOVERY OF THE SPRING COIL COULD NOT BE CONTROLLED BY THE PUSH ROD. THE SPRING COIL DETACHED ITSELF. THE SURGEON INDICATED THAT THE COIL HAD A QUALITY PROBLEM. IT WAS NOTED THAT COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL REMAINS IN THE PATIENT. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. ACTION/TREATMENT PLANNED TO SECURE THE COIL IS STENT PRESSURE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WA

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137437 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab